7000 Series Total Knee Modular Component Cement CA

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

510(k) Number

K922104 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteonics(R) Omnifit(R) Normalized Hip Stem

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  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

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  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

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• MC2P Acetabular Component Open recall

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  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 knee surgeries is this modular prosthesis designed for, and why is modularity important in this context?

  The 7000 Series Total Knee Modular Component Cement CA is specifically designed for total knee arthroplasty, a procedure to replace a damaged knee joint. Modularity is important because it allows surgeons to customize the implant to fit the patient’s unique anatomy, ensuring a better fit and stability. Since the device is semi-constrained, it also provides controlled movement while maintaining stability through cemented fixation, which is critical for long-term durability and patient recovery.

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

  This device is sterile and intended for single-use only, meaning it should not be reused after a single surgical procedure. To maintain sterility before use, it must be stored according to aseptic protocols—typically in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer’s instructions for storage should be followed to prevent contamination.

• What materials is the 7000 Series prosthesis made from, and how does that affect its performance?

  The prosthesis is constructed from a polymer/metal/polymer composite, combining durability with flexibility. The outer layers of polymer provide a smooth articulation surface, while the metal core offers structural integrity. This composite design helps reduce wear and tear on the implant while accommodating varying anatomical shapes through modular components, ensuring stable fixation when cemented into place during surgery.

• How do I confirm this device meets FDA requirements, and what classification does it fall under?

  This device has received FDA 510(k) clearance (K922104) under product code JWH, classifying it as a Class II special control prosthesis under the Orthopedic category. The clearance was granted through a traditional review process by the FDA’s Orthopedic (OR) Advisory Committee in 1992, confirming it meets regulatory standards for safety and effectiveness in its intended use for total knee arthroplasty.

• Can this device be used in outpatient settings, or is it strictly for in-hospital procedures?

  The 7000 Series Total Knee Modular Component Cement CA is intended for in-hospital surgical use only, as specified in its design and regulatory submission. While some knee procedures may be performed in outpatient or ambulatory settings, this particular device is not labeled for such use. Its modular, cemented design requires controlled surgical conditions to ensure proper implantation and sterility.