03.22.13
Alphatec Holdings Inc., parent company of Alphatec Spine, has been granted U.S. Food and Drug Administration 510(k) clearance to market the Alphatec Solus internal fixation anterior lumbar interbody fusion (ALIF) device.
The Alphatec Solus ALIF device features two counter-rotating titanium blades, which are designed to deploy into adjacent vertebrae on a zero-degree axis, locking the device in place. This provides four points of fixation delivered in a single step. The device, which is patented by Alphatec, reportedly provides enhanced segmental stability with a simplified surgical technique, while providing substantial spacing to insert bone graft to help promote rapid fusion at the site.
“We are extremely pleased to announce that the Alphatec Solus ALIF system will soon be available for commercial release within the United States,” said Les Cross, chairman and CEO of Alphatec Spine. “We launched Alphatec Solus in Europe in January this year and thus far it has been a success. Our product development programs will remain a collaborative effort between spine surgeons and our internal development group to ensure that the latest product innovations keep advancing improved patient care in the operating room.”
According to Millennium Research Group, a Canadian research group that gathers data on the medtech industry, the market for internal fixation ALIF spacer devices is estimated to be approximately $129 million in 2013, representing approximately half of the total market for the ALIF spacer devices.
Carlsbad, Calif.-based Alphatec Spine Inc. makes products for the treatment of spinal disorders associated with trauma, congenital deformities, disease and degeneration.
Stryker Introduces Mandibulo-Maxillary Fixation System
Kalamazoo, Mich.-based Stryker Corporation has released the Universal Smartlock hybrid MMF (mandibulo-maxillary fixation) system worldwide. The device has been granted 510(k) clearance by the U.S. Food and Drug Administration and also is available in international markets where it has been cleared for sale.
Inventor Jeffrey R. Marcus, M.D., associate vice chair of surgery at Duke University, in collaboration with Stryker, designed the system to combine the strength and rigidity of arch bars with the safety and efficiency of MMF screws.
“The Universal Smartlock hybrid MMF system is easy to apply, comfortable for the patients, and can impressively increase a surgeon’s efficiency,” said Michael D. Turner, M.D., associate director of oral and maxillofacial surgery at Beth Israel and Jacobi Medical Center in New York, N.Y.
According to the company, the Smartlock system’s nine potential points of fixation along the plate offers better posterior fixation and vector control. The screws have self-drilling locking technology, designed to allow purchase into both the bone and the plate for additional stability, and to eliminate the need for interdental wiring typically required with arch bars.
“The Universal Smartlock hybrid MMF system is an effective and technically simple process that may change the surgical management of maxillary and mandibular fixation for all surgical specialties,” said Jairo Bastidas, D.M.D., deputy director of oral and maxillofacial surgery at Montefiore Medical Center, New York, N.Y. “Closed reduction of the jaws can be accomplished with less exposure risk to the surgeon, decreased operative time and excellent skeletal stability. The Universal Smartlock hybrid MMF system is an innovation for the management of facial trauma.”
Stryker produces a range of medical devices in segments including surgical, neurotechnology, orthopedic and spine.
Zimmer Updates Spine Implant System, New Instruments Added
Minneapolis, Minn.-based Zimmer Spine has released the Zimmer DTO 5.5 system, an updated version of the company’s original DTO implant that received U.S. Food and Drug Administration approval in 2007. New implants and instruments have been added to the system, which is part of the Dynesys product family, so that the Dynesys dynamic stabilization system can be used with the company’s Sequoia pedicle screw system and Instinct Java spinal fixation system. According to Zimmer, the DTO 5.5 system enables clinicians to treat varying levels of disc degeneration at adjacent levels, integrating fusion and non-fusion treatments through a single construct.
The Dynesys system is a pedicle-screw fixation system—an implant device consisting of a spacer, cord and pedicle screw. It offers an approach to stabilization and mobilization of the spine and pain relief that relies on flexible materials and is purported to preserve much of the spinal anatomy. Dynesys can be used in skeletally mature patients to provide immobilization and stabilization of spinal segments. It is used as an adjunct to fusion to treat degenerative slipped discs (spondylolisthesis) in the thoracic, lumbar or sacral regions when there is evidence of resulting neurologic impairment or in the case of a previous failed fusion (pseudarthrosis).
The DTO 5.5 implant is so named because of the new 5.5 mm titanium rod, which is combined with a 100 mm polyethylene-terephthalate cord that can be contoured to match patient anatomy, according to the company.
“Many patients present with differing levels of disc degeneration at adjacent segments of the lumbar spine,” said Steve Healy, president of Zimmer Spine. “This makes it challenging for clinicians to effectively treat the entire pathology without the flexibility of combining fusion and non-fusion approaches.”
The new DTO system reportedly provides stabilization at levels adjacent to fusion while preserving contiguous segment anatomy and restoring posterior disc height. This is possible because the system offers the capability for transition from fusion to non-fusion within a single implant. According to the company, the DTO 5.5 streamlines reduction and compression capabilities that enable the treatment of a broad range of pathologies at contiguous levels, depending on patient need and clinician preference.
Zimmer Spine is a division of Zimmer Holdings Inc. based in Warsaw, Ind.
FDA Clears Patient-Specific Cranial Implant Device from OPM
Oxford Performance Materials (OPM), a South Windsor, Conn.-based manufacturer of polyetherketoneketone (PEKK) materials, has received U.S. Food and Drug Administration 510(k) clearance for its OsteoFab patient-specific cranial device. The device is an implant to replace gaps in the skull that may have been caused by trauma or disease, and therefore need to be highly customizable. OsteoFab is OPM’s brand for additively manufactured medical and implant parts produced from PEKK polymer. Using additive manufacturing (AM, also called 3-D printing), implants are “grown” layer by layer directly from a digital CAD (computer-aided design) file without the aid of tooling and with few practical limits on what can be produced, making it well-suited to create implants for specific anatomies.
PEKK is considered a high-performance polymer. Until now, OPM had traditionally sold the plastic as a raw material or in a semi-finished form, but the firm began developing AM technologies in 2006. In 2011, the company established a biomedical compliant manufacturing facility in South Windsor to support its growing additive manufacturing business. As an implantable polymer, PEKK is unique in that is biocompatible, mechanically similar to bone, and radiolucent so as not to interfere with X-ray equipment. Also, according to company tests, the OsteoFab implant is osteoconductive, which means it can act as a scaffold to which bone cells can attach and initiate bone growth.
“It is our firm belief that the combination of PEKK and additive manufacturing … is a highly transformative and disruptive technology platform that will substantially impact all sectors of the orthopedic industry,” said Scott DeFelice, president and CEO of OPM. “We have sought our first approval within cranial implants because the need was most compelling; however, this is just the beginning. We will now move systematically throughout the body in an effort to deliver improved outcomes at lower overall cost to the patient and healthcare provider.”
OPM makes biomedical raw materials, biomedical devices, and also has an industrial parts division.
ECA Medical Instruments Rolls Out a New Line of Products
Newbury Park, Calif.-based ECA Medical Instruments Inc., a designer of single-procedure torque-limiting and fixed-driver surgical instruments and kits, recently introduced a new line of fixed-driver surgical instruments featuring the company’s patented Wick Away technology. Wick Away is designed for use by orthopedic surgeons and is intended to provide a secure grip during surgical procedures by wicking away debris and fluids into the waffle geometry and crevices of the polymer handle. ECA sells Wick Away products as does its partner, Greatbatch Medical.
According to officials at ECA, the technology offers the tactile properties and grip needed by surgeons for procedures where a fixed-driver instrument is used to secure implant screws, fasteners and connectors. The line of Wick Away products includes single-procedure instruments for use in general orthopedic reconstructive surgery, small-bone and trauma procedures and for spine implants. Each instrument can be modified to conform to the stainless steel shaft lengths and tip geometries used by medical implant companies, officials also noted.
“Our family of fixed-driver instrumentation employing Wick Away technology received top marks from leading orthopedic surgeons during our product design and voice-of-the-customer studies,” said John Nino, ECA’s president and CEO. “The solid grip and ease of use are unprecedented in a disposable instrument and are a perfect complement to our single-procedure torque-limiting instruments and orthopedic procedural kits.”
According to the company, orthopedic implant makers are adopting sterile-packed, disposable torque-limiting and fixed-driver instruments to reduce per-procedure costs by eliminating some of the recurring operational overhead of traditional reusable instruments that require extensive handling, cleaning, inspection and re-sterilization after each use. Costly and potentially deadly hospital-borne and surgical-site infections also can be reduced by adopting sterile single-procedure instruments.
ECA’s kits may be purchased off-the-shelf for private label, or ECA works with OEMs on custom configurations.
The Alphatec Solus ALIF device features two counter-rotating titanium blades, which are designed to deploy into adjacent vertebrae on a zero-degree axis, locking the device in place. This provides four points of fixation delivered in a single step. The device, which is patented by Alphatec, reportedly provides enhanced segmental stability with a simplified surgical technique, while providing substantial spacing to insert bone graft to help promote rapid fusion at the site.
“We are extremely pleased to announce that the Alphatec Solus ALIF system will soon be available for commercial release within the United States,” said Les Cross, chairman and CEO of Alphatec Spine. “We launched Alphatec Solus in Europe in January this year and thus far it has been a success. Our product development programs will remain a collaborative effort between spine surgeons and our internal development group to ensure that the latest product innovations keep advancing improved patient care in the operating room.”
According to Millennium Research Group, a Canadian research group that gathers data on the medtech industry, the market for internal fixation ALIF spacer devices is estimated to be approximately $129 million in 2013, representing approximately half of the total market for the ALIF spacer devices.
Carlsbad, Calif.-based Alphatec Spine Inc. makes products for the treatment of spinal disorders associated with trauma, congenital deformities, disease and degeneration.
Stryker Introduces Mandibulo-Maxillary Fixation System
Kalamazoo, Mich.-based Stryker Corporation has released the Universal Smartlock hybrid MMF (mandibulo-maxillary fixation) system worldwide. The device has been granted 510(k) clearance by the U.S. Food and Drug Administration and also is available in international markets where it has been cleared for sale.
The Smartlock Hybrid MMF Plate. Photo courtesy of Stryker Corporation. |
“The Universal Smartlock hybrid MMF system is easy to apply, comfortable for the patients, and can impressively increase a surgeon’s efficiency,” said Michael D. Turner, M.D., associate director of oral and maxillofacial surgery at Beth Israel and Jacobi Medical Center in New York, N.Y.
According to the company, the Smartlock system’s nine potential points of fixation along the plate offers better posterior fixation and vector control. The screws have self-drilling locking technology, designed to allow purchase into both the bone and the plate for additional stability, and to eliminate the need for interdental wiring typically required with arch bars.
“The Universal Smartlock hybrid MMF system is an effective and technically simple process that may change the surgical management of maxillary and mandibular fixation for all surgical specialties,” said Jairo Bastidas, D.M.D., deputy director of oral and maxillofacial surgery at Montefiore Medical Center, New York, N.Y. “Closed reduction of the jaws can be accomplished with less exposure risk to the surgeon, decreased operative time and excellent skeletal stability. The Universal Smartlock hybrid MMF system is an innovation for the management of facial trauma.”
Stryker produces a range of medical devices in segments including surgical, neurotechnology, orthopedic and spine.
Zimmer Updates Spine Implant System, New Instruments Added
Minneapolis, Minn.-based Zimmer Spine has released the Zimmer DTO 5.5 system, an updated version of the company’s original DTO implant that received U.S. Food and Drug Administration approval in 2007. New implants and instruments have been added to the system, which is part of the Dynesys product family, so that the Dynesys dynamic stabilization system can be used with the company’s Sequoia pedicle screw system and Instinct Java spinal fixation system. According to Zimmer, the DTO 5.5 system enables clinicians to treat varying levels of disc degeneration at adjacent levels, integrating fusion and non-fusion treatments through a single construct.
The Dynesys system is a pedicle-screw fixation system—an implant device consisting of a spacer, cord and pedicle screw. It offers an approach to stabilization and mobilization of the spine and pain relief that relies on flexible materials and is purported to preserve much of the spinal anatomy. Dynesys can be used in skeletally mature patients to provide immobilization and stabilization of spinal segments. It is used as an adjunct to fusion to treat degenerative slipped discs (spondylolisthesis) in the thoracic, lumbar or sacral regions when there is evidence of resulting neurologic impairment or in the case of a previous failed fusion (pseudarthrosis).
The DTO 5.5 implant is so named because of the new 5.5 mm titanium rod, which is combined with a 100 mm polyethylene-terephthalate cord that can be contoured to match patient anatomy, according to the company.
“Many patients present with differing levels of disc degeneration at adjacent segments of the lumbar spine,” said Steve Healy, president of Zimmer Spine. “This makes it challenging for clinicians to effectively treat the entire pathology without the flexibility of combining fusion and non-fusion approaches.”
The new DTO system reportedly provides stabilization at levels adjacent to fusion while preserving contiguous segment anatomy and restoring posterior disc height. This is possible because the system offers the capability for transition from fusion to non-fusion within a single implant. According to the company, the DTO 5.5 streamlines reduction and compression capabilities that enable the treatment of a broad range of pathologies at contiguous levels, depending on patient need and clinician preference.
Zimmer Spine is a division of Zimmer Holdings Inc. based in Warsaw, Ind.
FDA Clears Patient-Specific Cranial Implant Device from OPM
Oxford Performance Materials (OPM), a South Windsor, Conn.-based manufacturer of polyetherketoneketone (PEKK) materials, has received U.S. Food and Drug Administration 510(k) clearance for its OsteoFab patient-specific cranial device. The device is an implant to replace gaps in the skull that may have been caused by trauma or disease, and therefore need to be highly customizable. OsteoFab is OPM’s brand for additively manufactured medical and implant parts produced from PEKK polymer. Using additive manufacturing (AM, also called 3-D printing), implants are “grown” layer by layer directly from a digital CAD (computer-aided design) file without the aid of tooling and with few practical limits on what can be produced, making it well-suited to create implants for specific anatomies.
A patient-specific cranial flap can be taken from a patient’s CT or MRI scan and converted to a CAD file. Oxford Performance Materials then creates a representative shape to fill the area of the bone defect and optimize that shape for load or biofunction, such as to promote natural bone ingrowth. Photo courtesy of Oxford Performance Materials. |
PEKK is considered a high-performance polymer. Until now, OPM had traditionally sold the plastic as a raw material or in a semi-finished form, but the firm began developing AM technologies in 2006. In 2011, the company established a biomedical compliant manufacturing facility in South Windsor to support its growing additive manufacturing business. As an implantable polymer, PEKK is unique in that is biocompatible, mechanically similar to bone, and radiolucent so as not to interfere with X-ray equipment. Also, according to company tests, the OsteoFab implant is osteoconductive, which means it can act as a scaffold to which bone cells can attach and initiate bone growth.
“It is our firm belief that the combination of PEKK and additive manufacturing … is a highly transformative and disruptive technology platform that will substantially impact all sectors of the orthopedic industry,” said Scott DeFelice, president and CEO of OPM. “We have sought our first approval within cranial implants because the need was most compelling; however, this is just the beginning. We will now move systematically throughout the body in an effort to deliver improved outcomes at lower overall cost to the patient and healthcare provider.”
OPM makes biomedical raw materials, biomedical devices, and also has an industrial parts division.
ECA Medical Instruments Rolls Out a New Line of Products
Newbury Park, Calif.-based ECA Medical Instruments Inc., a designer of single-procedure torque-limiting and fixed-driver surgical instruments and kits, recently introduced a new line of fixed-driver surgical instruments featuring the company’s patented Wick Away technology. Wick Away is designed for use by orthopedic surgeons and is intended to provide a secure grip during surgical procedures by wicking away debris and fluids into the waffle geometry and crevices of the polymer handle. ECA sells Wick Away products as does its partner, Greatbatch Medical.
According to officials at ECA, the technology offers the tactile properties and grip needed by surgeons for procedures where a fixed-driver instrument is used to secure implant screws, fasteners and connectors. The line of Wick Away products includes single-procedure instruments for use in general orthopedic reconstructive surgery, small-bone and trauma procedures and for spine implants. Each instrument can be modified to conform to the stainless steel shaft lengths and tip geometries used by medical implant companies, officials also noted.
“Our family of fixed-driver instrumentation employing Wick Away technology received top marks from leading orthopedic surgeons during our product design and voice-of-the-customer studies,” said John Nino, ECA’s president and CEO. “The solid grip and ease of use are unprecedented in a disposable instrument and are a perfect complement to our single-procedure torque-limiting instruments and orthopedic procedural kits.”
According to the company, orthopedic implant makers are adopting sterile-packed, disposable torque-limiting and fixed-driver instruments to reduce per-procedure costs by eliminating some of the recurring operational overhead of traditional reusable instruments that require extensive handling, cleaning, inspection and re-sterilization after each use. Costly and potentially deadly hospital-borne and surgical-site infections also can be reduced by adopting sterile single-procedure instruments.
ECA’s kits may be purchased off-the-shelf for private label, or ECA works with OEMs on custom configurations.