Omnifit Ceramic Morse Taper Head

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

510(k) Number

K894694 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

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 Ceramic Morse Taper Head used for?

  The Omnifit Ceramic Morse Taper Head is a semi-constrained component designed specifically for orthopedic hip replacement surgeries. It attaches securely to femoral stems via a Morse taper connection, ensuring stability and durability within the hip joint during load-bearing activities. This design is ideal for patients undergoing total or partial hip arthroplasty, where reliable fixation and long-term performance are critical.

• How is the Omnifit Ceramic Morse Taper Head supplied and prepared for use?

  This device is supplied as a reusable orthopedic implant, meaning it must undergo proper sterilization and handling procedures as outlined in medical protocols before use. It is intended exclusively for sterile operating environments to prevent contamination and ensure patient safety. Sterilization methods should follow manufacturer guidelines to maintain the integrity of the ceramic material and taper connection.

• Is the Omnifit Ceramic Morse Taper Head single-use or reusable?

  The Omnifit Ceramic Morse Taper Head is classified as a reusable implant. Reusability is contingent on adherence to strict sterilization protocols and manufacturer instructions to preserve functionality and prevent cross-contamination. Proper cleaning, sterilization, and storage are essential to maintain its performance for subsequent surgical procedures.

• What sizes or variations are available for the Omnifit Ceramic Morse Taper Head?

  The Omnifit Ceramic Morse Taper Head comes in specific sizes and variations, such as the 1002 Series, which are detailed in the manufacturer’s documentation. These sizes must be carefully matched to the corresponding femoral stem to ensure a proper fit and secure attachment. Always verify compatibility with the intended stem before use to avoid complications during surgery.

• How should the Omnifit Ceramic Morse Taper Head be stored?

  This device should be stored in a clean, dry environment protected from physical damage, moisture, and contamination. Storage conditions must comply with medical device regulations and manufacturer recommendations to preserve sterility and functionality. If reusable, it should be stored in a way that allows for easy access to sterilization packaging and documentation.