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Orthopro, LLC

United StatesFDA applicant, unverified

Devices
11
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Orthopro, LLC makes

Orthopro, LLC manufactures orthopedic fixation devices for foot and ankle surgery, including systems for hammer toe correction, Steinman pins and Kirschner wires, screw-based implants, hemi-toe prosthetics, metal implants, and trauma stabilization for the ankle and ulna. Their portfolio also includes devices for ulnar shortening procedures.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • I-Fuse Hammer Toe Systems Ref K113006

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Orthopro Steinman Pins And Kirschner Wires Ref K070555

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ortho-Pro Cannulated Bone Screws Ref K042310

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Orthoflex Rod Ref K102601

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tc Plating System Ref K094037

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Csts Screw Ref K093055

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sts Screw Ref K032682

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Orthropro Hemi Toe Ref K062908

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Metal Hemi Implant Ref K071243

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dc Ulnar Shortening System Ref K073228

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ankle Trauma System Ref K122936

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-11 of 11

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Orthopro, LLC, initiated on 2008-05-29. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use and sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2008

    • 29 May 2008 Z-2228-2008 Unclassified (pre-2012) Terminated Labeling presented conflicting information as to whether device was sterile or not. Distribution: AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA. Submission number: K071243

Frequently asked questions

How many devices does Orthopro, LLC have in the registry?

The registry currently lists 11 devices for Orthopro, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Orthopro, LLC's devices?

Among its 11 most recently registered devices, Orthopro, LLC has devices listed in FDA 510(k) (11 devices).

What risk classes do Orthopro, LLC's devices fall under?

Among its 11 most recently registered devices, the classes recorded for Orthopro, LLC's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Orthopro, LLC?

FDA recall records list 1 recall initiated by Orthopro, LLC, the most recent initiated on 29 May 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Orthopro, LLC in the registry?

The most recently registered devices listed for Orthopro, LLC include I-FUSE HAMMER TOE SYSTEMS, ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES, ORTHO-PRO CANNULATED BONE SCREWS and ORTHOFLEX ROD.

Generated automatically from registry data and not verified by a human reviewer.