Osteo Steinmann Pin

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922194 ↗

FDA Product Code

HTY

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteo Ex-Fi-Re

  Class II

  FDA 510(k) K920149 Active Cleared 9 Apr 1992

• Osteo Kirschner Wire

  Class II

  FDA 510(k) K922193 Active Cleared 23 Jul 1992

• Osteo Compression Hip Screw

  Class II

  FDA 510(k) K920037 Active Cleared 11 Mar 1992

• Osteo Interlocking-Compression Nail

  Class II

  FDA 510(k) K933340 Active Cleared 30 Jun 1994

• Osteo Femoral Nail

  Class II

  FDA 510(k) K922195 Active Cleared 23 Jul 1992

• Osteo Complete Pneumatic Drill-Oscilair

  Class I

  FDA 510(k) K913559 Active Cleared 7 Nov 1991

See all devices from Osteo AG →

• What is the Osteo Steinmann Pin used for?

  The Osteo Steinmann Pin is designed for intramedullary splinting of long bone fractures. It acts as a temporary external fixation device, inserted into the medullary cavity to stabilize bone fragments and maintain proper alignment during the healing process. This aids in preparing the bone for definitive internal fixation when permanent stabilization is needed.

• Is the Osteo Steinmann Pin reusable or single-use?

  The Osteo Steinmann Pin is classified as a reusable orthopedic instrument. It is intended for surgical settings and use by trained medical professionals, though the regulatory data does not explicitly specify sterility or single-use requirements.

• What sizes or models are available for the Osteo Steinmann Pin?

  The provided specifications do not include details on available sizes or specific model references for the Osteo Steinmann Pin. For precise sizing information, consult the manufacturer’s product catalog or technical documentation.

• How is the Osteo Steinmann Pin supplied?

  The device is supplied as a reusable orthopedic instrument, intended for use in surgical environments. Packaging specifics, such as sterilization packaging or quantity per box, are not detailed in the regulatory submission.

• What regulatory clearance does the Osteo Steinmann Pin hold?

  The Osteo Steinmann Pin holds a Traditional 510(k) clearance (K922194) from the FDA, granted in 1992. It is classified under FDA regulation 888.3040 as a Pin, Fixation, Smooth, and falls under Device Class II.