Femoral & Tibial Augment Block

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

510(k) Number

K924940 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• S-ROM Total Hip Replacement System

  Class II

  FDA 510(k) K920739 Active Cleared 24 Nov 1992

• S-ROM ZTT Acetabular Cup-Apical Hole Plug

  Class III

  FDA 510(k) K931676 Active Cleared 18 May 1994

• S-Rom Femoral Hip Stem - Size 14 X 8

  Class II

  FDA 510(k) K954935 Active Cleared 22 Jan 1996

• Knee Prothesis

  Class II

  FDA 510(k) K941769 Active Cleared 1 Feb 1995

• Src Total Knee

  Not classified

  FDA 510(k) K841022 Active Cleared 25 Jun 1984

• S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis

  Class II

  FDA 510(k) K951084 Active Cleared 31 May 1995

See all devices from Joint Medical Products Corp. →

• What is the Femoral & Tibial Augment Block used for?

  The Femoral & Tibial Augment Block is designed to address bone defects in the femur or tibia during knee joint replacement surgeries. It provides additional structural support where standard prosthetic implants may not suffice, helping restore alignment and stability in the knee joint. This modular implant is particularly useful in cases requiring extra reinforcement beyond conventional arthroplasty components.

• How is the Femoral & Tibial Augment Block supplied and prepared for use?

  The device is supplied as a reusable surgical implant, intended for use in controlled operating room environments. It must be handled and stored according to sterile surgical instrument protocols to preserve its integrity before use. The cobalt-chromium-molybdenum alloy construction ensures durability, while ultra-high molecular weight polyethylene components maintain biocompatibility.

• Is the Femoral & Tibial Augment Block single-use or reusable?

  This augment block is explicitly designed for reuse within a sterile surgical setting. Its modular construction and robust materials—cobalt-chromium-molybdenum alloy and ultra-high molecular weight polyethylene—allow for repeated use under proper sterilization and handling procedures. Reusability is supported by FDA clearance under 510(k) K924940, provided adherence to sterile protocols is maintained.

• What materials are used in the Femoral & Tibial Augment Block?

  The augment block features cobalt-chromium-molybdenum alloys for its structural components, offering high strength and corrosion resistance. Ultra-high molecular weight polyethylene is incorporated for articulating surfaces, ensuring smooth motion and biocompatibility. These materials are selected for their durability, longevity, and compatibility with the human body in orthopedic applications.

• How should the Femoral & Tibial Augment Block be stored?

  Storage must comply with standard sterile surgical instrument protocols to prevent contamination or damage. The device should be kept in a clean, dry environment, protected from physical stress or exposure to chemicals. Since it is reusable, it must undergo proper sterilization between uses, adhering to FDA guidelines for orthopedic implants under 21 CFR 888.3560. Always follow manufacturer instructions for packaging and storage to maintain sterility and functionality.