Omniflex Normalized Hip Stem for Press-Fit Fixat.

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

510(k) Number

K872768 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

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 is the Omniflex Normalized Hip Stem primarily used for in surgical procedures?

  The Omniflex Normalized Hip Stem is designed for press-fit fixation in total hip arthroplasty, providing stable fixation within the femoral canal without the need for cement. It is a semi-constrained, metal, uncemented acetabular prosthesis intended to offer a durable solution for patients undergoing hip joint replacement.

• Is the Omniflex Normalized Hip Stem intended for single-use or reusable applications?

  The Omniflex Normalized Hip Stem is explicitly supplied as a reusable surgical implant. It is intended for multiple uses in orthopedic procedures, provided it adheres to sterile packaging and reprocessing guidelines.

• How is the Omniflex Normalized Hip Stem regulated in the U.S., and what does that mean for its use?

  The device is regulated under FDA 510(k) clearance (K872768) and classified as a Class III medical device, meaning it undergoes rigorous review to ensure safety and effectiveness. The clearance was granted under the 'Substantially Equivalent' decision, indicating it meets the performance criteria of a predicate device. This classification ensures compliance with strict manufacturing, labeling, and post-market surveillance requirements.

• What packaging and sterility requirements apply to the Omniflex Normalized Hip Stem?

  The Omniflex Normalized Hip Stem must be supplied in sterile packaging to ensure aseptic conditions for surgical use. Sterility is critical for orthopedic implants to prevent infection and complications during hip replacement procedures.

• Does the Omniflex Normalized Hip Stem come in multiple sizes or models, and how are they differentiated?

  While the provided data does not specify exact sizes or model variations in detail, the multiple FEI numbers (e.g., 3020282716, 1047843) indicate different manufacturing variants or configurations. These likely correspond to variations in stem design, length, or other clinical parameters to accommodate diverse patient anatomies. For precise sizing, refer to the manufacturer’s catalog or surgical planning tools.