Osteo Small and Mini Bone Screws

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

510(k) Number

K971778 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →

• What are the Osteo Small and Mini Bone Screws designed for?

  These screws are specifically engineered for internal fracture fixation of small bones, providing mechanical support to stabilize bone fragments and promote proper healing during the bone union process. They are intended for use in smaller anatomical sites where standard fixation hardware may not be suitable.

• Are the Osteo Small and Mini Bone Screws available in sterile and non-sterile versions?

  Yes, the screws are supplied in both sterile and non-sterile configurations to accommodate different surgical settings. When used in sterile environments, they must be handled according to sterile protocols to ensure patient safety.

• Are these screws intended for single-use or reusable applications?

  The Osteo Small and Mini Bone Screws are designed for single-use applications only. This ensures patient safety and reduces the risk of infection or contamination associated with reuse.

• What regulatory clearance does this device have?

  The Osteo Small and Mini Bone Screws received a Traditional 510(k) clearance from the FDA, classified under Product Code HWC. This clearance establishes that the device is substantially equivalent to a predicate device already on the market.

• How should these screws be stored before use?

  For sterile configurations, storage should follow the manufacturer’s guidelines to maintain sterility until use. Non-sterile screws should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for specific storage instructions.