OEM News

FDA Roundup: Clearance for 45 Orthopedic Devices in March

A total of 35 orthopedic companies received good news from the agency last month.

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

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