04.17.15
A rundown of the U.S. Food and Drug Administration's product approvals and clearances for March 2015:
Company: Aesculap Implants System LLC
Device: Vega knee system, Columbus total knee system
Company: Biomet Spine (Biomet Inc.)
Device: Biomet Spine fusion system; Biomet proximal humerus plating system
Company: Blue Belt Technologies Inc.
Device: Navio
Company: Consensus Orthopedics Inc.
Device: Consensus knee system modular tibial baseplate
Company: Cayenne Medical Inc.
Device: Short Surelock all-suture anchor
Company: Depuy Synthes Companies
Device: Rapidsorb injectable polymer system; DePuy Synthes variable angle locking hand system
Company: Degen Medical Inc.
Device: F1-modular pedicle screw system
Company: Extremity Medical LLC
Device: Extremity medical calcaneal osteotomy device
Company: Ellipse Technologies Inc.
Device: MAGEC spinal bracing and distraction system
Company: Eminent Spine LLC
Device: Eminent foot plate system
Company: Fournitures Hospitalieres Industries
Device: Arrow reverse shoulder long keel and short keel glenoid base
Company: Jiangsu Ideal Medical Science & Technology Co. Ltd.
Device: Ideal locking plate system
Company: K2M Inc.
Device: Range/Denali/Mesa spinal system
Company: L&K Biomed Co. Ltd.
Device: LnK anterior cervical plate system
Company: Life Spine Inc.
Device: Tarsa-link wedge fixation system; Nautilus spinal system
Company: Mako Surgical Corp.
Device: Restoris porous partial knee system
Company: Micromar Industria e Comercio Ltda
Device: Easydrill Autostop cranial perforator
Company: Medacta International
Device: Mpact double mobility system
Company: Miami Device Solutions LLC
Device: Proximal humerus plating system
Company: Medicrea International SA
Device: PASS LP spinal system
Company: NuVasive Inc.
Device: NuVasive Coroent system; Affix IIS spinous process plate system; NuVasive NVM5 system
Company: Pioneer Surgical Technology Inc. (becoming RTI Surgical Inc.)
Device: Nerve monitoring cable system
Company: The Progressive Orthopaedic Company LLC
Device: Progressive orthopedic total knee system
Company: Smith & Nephew plc
Device: SL-plus MIA and SL-plus femoral stems with Ti/HA
Company: Stryker Corp.
Device: Stryker CMF Medpor customized implant; AccuLIF TL and PL cage; LITe plate system
Company: Signature Orthopaedics Pty Ltd.
Device: Evolve Unipolar head
Company: Spine Wave Inc.
Device: Leva spacer system
Company: SeaSpine Inc.
Device: Integra laminoplasty system
Company: Tornier Inc.
Device: Simpliciti shoulder system
Company: Wright Medical Technology Inc.
Device: Infinity total ankle system; Inbone total ankle system; Invision total ankle revision system; Salvation external fixation syste
Company: Xenco Medical LLC
Device: Xenco medical lumbar interbody system
Company: Zimmer Holdings Inc.
Device: Herbert/Whipple bone screw system; Zimmer plates and screws system—non-sterile ZPS
Company: Zimmer Spine Inc.
Device: Invizia anterior cervical plate system
Company: Aesculap Implants System LLC
Device: Vega knee system, Columbus total knee system
Company: Biomet Spine (Biomet Inc.)
Device: Biomet Spine fusion system; Biomet proximal humerus plating system
Company: Blue Belt Technologies Inc.
Device: Navio
Company: Consensus Orthopedics Inc.
Device: Consensus knee system modular tibial baseplate
Company: Cayenne Medical Inc.
Device: Short Surelock all-suture anchor
Company: Depuy Synthes Companies
Device: Rapidsorb injectable polymer system; DePuy Synthes variable angle locking hand system
Company: Degen Medical Inc.
Device: F1-modular pedicle screw system
Company: Extremity Medical LLC
Device: Extremity medical calcaneal osteotomy device
Company: Ellipse Technologies Inc.
Device: MAGEC spinal bracing and distraction system
Company: Eminent Spine LLC
Device: Eminent foot plate system
Company: Fournitures Hospitalieres Industries
Device: Arrow reverse shoulder long keel and short keel glenoid base
Company: Jiangsu Ideal Medical Science & Technology Co. Ltd.
Device: Ideal locking plate system
Company: K2M Inc.
Device: Range/Denali/Mesa spinal system
Company: L&K Biomed Co. Ltd.
Device: LnK anterior cervical plate system
Company: Life Spine Inc.
Device: Tarsa-link wedge fixation system; Nautilus spinal system
Company: Mako Surgical Corp.
Device: Restoris porous partial knee system
Company: Micromar Industria e Comercio Ltda
Device: Easydrill Autostop cranial perforator
Company: Medacta International
Device: Mpact double mobility system
Company: Miami Device Solutions LLC
Device: Proximal humerus plating system
Company: Medicrea International SA
Device: PASS LP spinal system
Company: NuVasive Inc.
Device: NuVasive Coroent system; Affix IIS spinous process plate system; NuVasive NVM5 system
Company: Pioneer Surgical Technology Inc. (becoming RTI Surgical Inc.)
Device: Nerve monitoring cable system
Company: The Progressive Orthopaedic Company LLC
Device: Progressive orthopedic total knee system
Company: Smith & Nephew plc
Device: SL-plus MIA and SL-plus femoral stems with Ti/HA
Company: Stryker Corp.
Device: Stryker CMF Medpor customized implant; AccuLIF TL and PL cage; LITe plate system
Company: Signature Orthopaedics Pty Ltd.
Device: Evolve Unipolar head
Company: Spine Wave Inc.
Device: Leva spacer system
Company: SeaSpine Inc.
Device: Integra laminoplasty system
Company: Tornier Inc.
Device: Simpliciti shoulder system
Company: Wright Medical Technology Inc.
Device: Infinity total ankle system; Inbone total ankle system; Invision total ankle revision system; Salvation external fixation syste
Company: Xenco Medical LLC
Device: Xenco medical lumbar interbody system
Company: Zimmer Holdings Inc.
Device: Herbert/Whipple bone screw system; Zimmer plates and screws system—non-sterile ZPS
Company: Zimmer Spine Inc.
Device: Invizia anterior cervical plate system