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Strategic Orthopaedic-related 510(k) Update

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.

Altus Spine

Pedicle Screw System, K132280*

  • Non-cervical fixation/stabilization device for the treatment of severe spondylolisthesis; immobilization/stabilization an adjunct to fusion to treat acute, chronic instabilities or deformities of the thoracic, lumbar and sacral spine
  • Titanium alloy, supplied non-sterile

Anchor Innovation Medical

AIM Suture Anchor, K132461*

  • 1.7mm diameter PEEK anchor, pre-mounted on disposable inserter, preloaded with USP size 0 Ultra
  • High Molecular Weight Polyethylene suture
  • For arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone in hand, wrist, foot, ankle

Beijing Libeier Bio-Engineering Institute

Locking Plate, K132642*

  • Titanium Locking Plate System for adult patients for fracture fixation in ulna, radius, humerus, femur, tibia, fibula

Binder Biomedical

Logic Standalone Intervertebral Body Fusion Device, K130641

  • PEEK spacer with titanium bone screws for intervertebral body fusion
  • For use with autogenous bone graft to treat degenerative disc disease at one or two contiguous levels of the lumbosacral spine

Corentec

Lospa IS Pedicle Screw, Straight and Pre-bent Rods, K132644

  • For immobilization and stabilization of spinal segments in skeletally mature patients as adjunct to fusion in the treatment of acute and chronic instabilities or deformities; for anterior screw fixation in the treatment of degenerative disc disease
  • Titanium; pre-bent rod is additionally available in CoCrMo alloy

Elite Surgical

Biolign Transforaminal Lumbar Interbody Fusion and Anterior Cervical Interbody Fusion Systems, Stand Alone Cervical Cage ACIF, K130274

  • TLIF: Slightly curved PEEK Optima cage with tantalum markers, used with supplemental fixation/autograft bone graft, posterolateral insertion
  • ACIF: PEEK Optima cage in 2 footprints, various sizes, used with autograft bone
  • STACC: Anatomically-shaped PEEK Optima ring, can be packed with autograft, implanted via anterior approach

Innovative Surgical Designs

True Spinal Fixation System, K130958*

  • Titanium alloy, pairs of longitudinal rods, polyaxial pedicle screws and rod/rod connectors
  • Intended for use only as a dual rod system
  • For posterior, non-cervical pedicle fixation to provide immobilization and stabilization as an adjunct to fusion to treat acute and chronic instabilities or deformities

Intelligent Implant

Marauder Cervical-Thoracic Spinal Fixation System, K132900

  • Titanium temporary construct intended to stabilize spinal operative site during posterior fusion by means of hooks and screws joined with spinal rods; removed after fusion

Jeil Medical

Arix Foot System, K131311

  • Unalloyed Titanium and Titanium Alloy
  • Intended for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid- and hind foot and ankle

NovoSource

NovoKnee Total Knee, K131398

  • Cruciate retaining version of NovoKnee Total Knee
  • Has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint

Tyber Medical

Interbody System: ACIF, ALIF, PLIF, TLIF, DLIF, K130573*

  • PEEK Optima or PEEK with plasma-sprayed commercially pure titanium coated implants, "toothed" exterior superior and inferior surfaces
  • Indicated as intervertebral fusion device in the treatment of degenerative disc disease at one level of cervical spine, placed via anterior approach using autogenous bone

Source: FDA 510(k) Releasable Database, 9/13-10/13; news releases, company web sites

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