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Strategic Orthopaedic-related 510(k) Update

Tags: fda, supplier, regulatory, industry watch, device company, oem, 510k, 510(k)

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

Algea Therapies
Affirm Vertebral Compression Fracture System, K110998*

  • Inflatable bone tamp for use with PMMA cement

Apex Tools & Orthopedics
Kirschner Wires and Steinmann Pins, K112254*

  • Supplier company (See the Supplier Directory)

Aston Medical
Duocentric Reversed Shoulder, K103251*

  • Cemented or uncemented
  • Polyethylene UHMW insert, titanium alloy screws, stainless steel stem/baseplates, hydroxyapatite coating for stem, double coating of titanium and hydroxyapatite for baseplate

Captiva Spine
CapLOX II Spinal Fixation System, K111115

  • Titanium alloy posterior, non-cervical pedicle fixation system

ExtraOrtho
Xtrafix External Fixation System, K111155*

  • Clamps feature 80° of motion
  • Pinch-Lock feature ensures that bars stay attached to clamps during fracture reduction
  • Company recently acquired by Zimmer

Internal Fixation Systems
Bone Plates, Screws, Washers, K110086

  • Titanium 6A1-4V ELI or stainless steel

Intuitive Spine
Discovery Intervertebral Fusion Device, K111484*

  • PEEK Optima LT I, includes tantalum markers; for anterior cervical interbody fusion
  • Low cost device manufacturer

Kalitec Direct
Odalys Pedicle Screw, K111370*

  • Titanium alloy, for dorsal stabilization of the spine

Konigsee Implantate
SFC Vertebral Body Replacement, K110153*

  • Company based in Germany

Mahe Medical
Perfect Spine Pedicle Screw, K110655

  • Supplier company (See the Supplier Directory)

Medical Concepts
Interbody Fusion System, K110659*

  • PEEK Optima LTl, includes tantalum markers; for cervical/lumbar intervertebral body fusion and vertebral body replacement

Mediscope Manufacturing
Compression Staple and Accessories, K102387*

  • Supplier company

Quantum Medical Concepts
Framewalker Fixation Device, K111993*

  • Company based in Portland, Oregon

SpineWorks
A-Wedge Anterior Interbody System, K111166

  • PEEK-OPTIMA LT1 polymer

Tarsus Medical
Meta-Lock Suture Anchor, K110800*

  • Titanium, stainless steel, polyester

TGM Medical
Helicon Hip System, K111472*

  • Porous-coated, semi-constrained prosthesis for primary or revision hip arthroplasty
  • CoCr femoral head, non-crosslinked UHMWPE insert

Thompson MIS
Bonebac T-PLIF Intervertebral Body Fusion System, K111512*

  • Implants made of Solvay Zeniva ZA-500 PEEK

Source: FDA 510(k) Releasable Database, 9/11 and 10/11

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