Strategic Orthopaedic-related 510(k) Update

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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