Osteo Compression Hip Screw System

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

510(k) Number

K971654 ↗

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 types of fractures is this system specifically designed to stabilize, and how does it work to achieve stability?

  The Osteo Compression Hip Screw System is designed to stabilize intertrochanteric femoral fractures and intracapsular femoral neck fractures. It achieves stability through a combination of a compression hip screw plate, lag screws, and a compression screw. The system is engineered to engage the femoral head while minimizing soft tissue irritation, allowing for optimal bone fragment impaction and secure fixation.

• Is this device reusable, or is it intended for single-use only? How should it be stored to maintain sterility?

  The Osteo Compression Hip Screw System is sterile and intended for single-use only. To maintain sterility and functionality, it must be handled and stored strictly according to the manufacturer’s instructions, as outlined in the provided documentation.

• What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this submission?

  This device received FDA 510(k) clearance (K971654) under the Traditional clearance type, determined to be substantially equivalent to a predicate device. The submission was reviewed by the Orthopedic (OR) Advisory Committee, which categorizes submissions under the Hip Screw System (Product Code: HWC) classification.

• Can this device be used in an MRI environment, or are there any special handling considerations?

  The Osteo Compression Hip Screw System is not MRI-safe. This means it should not be used in an MRI environment, as the magnetic fields could cause interference or harm. Always follow manufacturer guidelines for safe handling and disposal.

• What surgical context is this device intended for, and why is minimizing soft tissue irritation important?

  This system is intended for orthopedic surgical use under sterile conditions to fix proximal femoral fractures. Minimizing soft tissue irritation is critical because it reduces postoperative complications, such as wound healing issues or infection, while ensuring the device remains securely positioned for optimal bone healing.