Michael Barbella, Managing Editor06.04.22
Product news drove the lion's share of ODT website traffic this past week.
Stryker, Embody Inc., and SI-BONE each gained regulatory clearances for their respective products, while Enovis Corp. attracted cybervisitors with its purchase of Outcome-Based Technologies.
Embody received FDA clearance for its TAPESTRY RC system to treat rotator cuff disease. Designed for arthroscopic procedures, the product combines the TAPESTRY biointegrative collagen implant’s healing benefits with streamlined delivery and bioabsorbable anchor fixation. TAPESTRY RC’s arthroscopic introducer is pre-loaded with the implant. The fully bioabsorbable fixation anchors are the first of their kind cleared for tendon and bone fixation in a pre-loaded anchor inserter, according to the company.
Stryker, meanwhile, earned FDA 510(k) clearance for its Q Guidance System. When used with the company’s Spine Guidance Software, the system is an advanced planning and intra-op guidance tool for open or percutaneous computer-assisted surgery. The Q Guidance System was designed to deliver spine surgery planning and navigation via multiple tracking options, software algorithms, and smart instrumentation. It features redesigned software applications, semi-auto and auto segmentation, gesture recognition, and broad image set compatibility.
Finally, the FDA granted SI-BONE 510(k) clearance for its iFuse Bedrock Granite implant system for sacroiliac fusion and sacropelvic fixation as a foundation for segmental spinal fusion. Granite was previously awarded FDA breakthrough designation and recently granted a proposal by the Centers for Medicare and Medicaid Services (CMS) for a New Technology Add-on Payment (NTAP). CMS also gave new technology “Section X” ICD-10 unique procedure coding for hospitals to report NTAP eligible cases that use Granite as an internal fixation device with tulip connector for open or percutaneous sacroiliac joint fusion and sacropelvic fixation.
Amid all the product clearances, Enovis Corp.’s subsidiary DJO garnered page views with its acquisition of Outcome-Based Technologies, which will allow the firm to enter the fast-growing hip bracing market. The newly gained EXCYBAIR hip brace touts a lower profile design and ease of use to raise compliance. Its modular components allow for specific protocols tailored to each patient. The brace’s soft components have strapping for enhanced range of motion restrictions at the hip. EXCYBAIR also integrates the option to supplement with cold therapy paired to the brace in order to add stronger pain management.
Stryker, Embody Inc., and SI-BONE each gained regulatory clearances for their respective products, while Enovis Corp. attracted cybervisitors with its purchase of Outcome-Based Technologies.
Embody received FDA clearance for its TAPESTRY RC system to treat rotator cuff disease. Designed for arthroscopic procedures, the product combines the TAPESTRY biointegrative collagen implant’s healing benefits with streamlined delivery and bioabsorbable anchor fixation. TAPESTRY RC’s arthroscopic introducer is pre-loaded with the implant. The fully bioabsorbable fixation anchors are the first of their kind cleared for tendon and bone fixation in a pre-loaded anchor inserter, according to the company.
Stryker, meanwhile, earned FDA 510(k) clearance for its Q Guidance System. When used with the company’s Spine Guidance Software, the system is an advanced planning and intra-op guidance tool for open or percutaneous computer-assisted surgery. The Q Guidance System was designed to deliver spine surgery planning and navigation via multiple tracking options, software algorithms, and smart instrumentation. It features redesigned software applications, semi-auto and auto segmentation, gesture recognition, and broad image set compatibility.
Finally, the FDA granted SI-BONE 510(k) clearance for its iFuse Bedrock Granite implant system for sacroiliac fusion and sacropelvic fixation as a foundation for segmental spinal fusion. Granite was previously awarded FDA breakthrough designation and recently granted a proposal by the Centers for Medicare and Medicaid Services (CMS) for a New Technology Add-on Payment (NTAP). CMS also gave new technology “Section X” ICD-10 unique procedure coding for hospitals to report NTAP eligible cases that use Granite as an internal fixation device with tulip connector for open or percutaneous sacroiliac joint fusion and sacropelvic fixation.
Amid all the product clearances, Enovis Corp.’s subsidiary DJO garnered page views with its acquisition of Outcome-Based Technologies, which will allow the firm to enter the fast-growing hip bracing market. The newly gained EXCYBAIR hip brace touts a lower profile design and ease of use to raise compliance. Its modular components allow for specific protocols tailored to each patient. The brace’s soft components have strapping for enhanced range of motion restrictions at the hip. EXCYBAIR also integrates the option to supplement with cold therapy paired to the brace in order to add stronger pain management.