Osteonics Microsutered Femoral Componentes

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

510(k) Number

K926201 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

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 Osteonics Microsutered Femoral Component used for?

  This device is designed specifically for orthopedic hip arthroplasty, serving as part of a total hip prosthesis system. Its primary purpose is to provide structural support and facilitate articulation within the hip joint, while the microsutered surface promotes better osseointegration—meaning it encourages the surrounding bone to grow and bond more effectively to the implant for improved stability.

• How is the Osteonics Microsutered Femoral Component supplied and prepared for use?

  The component is supplied as a single-use, sterile implant, meaning it is intended for one surgical procedure only and must remain unopened until use. Sterility and integrity must be maintained by following the manufacturer’s guidelines for handling and storage, which include keeping it in its original packaging until implantation.

• Is the device reusable or intended for single-use only?

  This femoral component is explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, structural integrity, or performance. Single-use ensures patient safety and compliance with regulatory standards.

• What distinguishes the microsutered surface of this femoral component?

  The microsutered surface is a textured design engineered to enhance osseointegration—the process where bone grows directly into the implant. This texture increases the surface area for bone attachment, improving stability and longevity of the hip prosthesis compared to smoother alternatives.

• Can this femoral component be used in MRI procedures?

  No, the Osteonics Microsutered Femoral Component is explicitly not intended for MRI use. MRI scans involve strong magnetic fields and radio waves that could potentially affect metallic implants, posing risks to both the patient and the imaging equipment. Always verify compatibility with the manufacturer’s guidelines before any MRI procedure.