Omnifit Acetabular Shell Cement Spacer System

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

510(k) Number

K882812 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

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 Omnifit Acetabular Shell Cement Spacer System used for?

  The Omnifit Acetabular Shell Cement Spacer System is designed for use in orthopedic hip arthroplasty procedures. It serves as a semi-constrained acetabular prosthesis, providing structural stability when cemented into place. This system is particularly useful in cases requiring temporary or permanent fixation of the acetabular component, ensuring proper alignment and support during joint reconstruction.

• How is the Omnifit Acetabular Shell Cement Spacer System supplied and what are its sterility and usage guidelines?

  The system is supplied as a sterile, single-use device, meaning it is intended for one-time use only to prevent contamination and ensure patient safety. Proper handling and storage are critical to maintain its sterility and structural integrity before use. Always follow manufacturer guidelines for unpacking and preparing the device in a sterile field during surgery.

• Is the Omnifit Acetabular Shell Cement Spacer System reusable, and if not, why?

  No, the Omnifit Acetabular Shell Cement Spacer System is not reusable. It is classified as a single-use device to minimize infection risks and ensure consistent performance. Reusing medical devices, especially those in direct contact with the body, can introduce contaminants and compromise sterility, which is why this system is designed for one surgical procedure only.

• What regulatory clearance does the Omnifit Acetabular Shell Cement Spacer System hold?

  The system holds FDA 510(k) clearance under the classification of a Class II medical device, with a clearance number of K882812. This clearance was granted through the Orthopedic Advisory Committee, indicating it was deemed substantially equivalent to a legally marketed predicate device. The clearance process involved a traditional review pathway without third-party review.

• What product code and advisory committee classification does this device fall under?

  The Omnifit Acetabular Shell Cement Spacer System is classified under product code JDI, which corresponds to prostheses for hip replacement. It was reviewed and cleared by the Orthopedic Advisory Committee (OR), reflecting its classification as a hip-related orthopedic device intended for cemented fixation in surgical procedures.