Ultima Cemented Long Stem Femoral Component

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K952859 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SN

• P.F.C. Uni-Compartmental Knee System

  Class II

  FDA 510(k) K954481 Active Cleared 10 Oct 1996

• J & J Cardiovascular Maxima Hollow Fiber Oxygenato

  Class II

  FDA 510(k) K853251 Active Cleared 16 Oct 1985

• Darwin Knee System (TC3)

  Class II

  FDA 510(k) K952830 Active Cleared 18 Jan 1996

• Adaptalite* Porcelain Veneer Cementation System

  Class II

  FDA 510(k) K871295 Active Cleared 29 May 1987

• Coman(R) Cu-11 Model Number 82-6634

  Class II

  FDA 510(k) K945585 Active Cleared 26 Oct 1995

• Fotofill Activator Light

  Class II

  FDA 510(k) K772278 Active Cleared 3 Jan 1978

See all devices from Johnson & Johnson Professionals, Inc. →

• What types of patients is the Ultima Cemented Long Stem Femoral Component intended to support with its design features?

  This device is designed for patients undergoing total hip arthroplasty who require deep femoral fixation, such as those with degenerative joint disease or trauma. The long stem and cemented fixation provide structural support and stability, limiting joint translation and rotation to restore mobility. The semi-constrained design helps maintain joint alignment during movement.

• How is the Ultima Cemented Long Stem Femoral Component supplied, and what does that mean for surgical planning?

  The device is supplied sterile and intended for single-use only, meaning it must be used once per patient and discarded afterward. This ensures infection control and compliance with aseptic surgical techniques. Clinicians should plan accordingly, accounting for inventory management and proper sterilization of surgical tools for each procedure.

• What material is the Ultima Cemented Long Stem Femoral Component made from, and why does that matter?

  The component is constructed from cobalt-chromium-molybdenum alloy, a durable material known for its strength and corrosion resistance. This choice is critical for long-term stability in the femur, as it ensures the implant can withstand mechanical stresses while maintaining biocompatibility with surrounding bone and tissue.

• Is this device reusable, or does it require special handling after use?

  The Ultima Cemented Long Stem Femoral Component is explicitly intended for single-use only and must not be reused. Since it is supplied sterile, any unused portion cannot be reprocessed or sterilized for later use. This aligns with best practices for infection control in orthopedic surgery, where single-use implants minimize cross-contamination risks.

• What regulatory pathway does the Ultima Cemented Long Stem Femoral Component follow, and what does that mean for purchasing or clinical use?

  The device holds a FDA 510(k) clearance (K952859) under product code JDI, indicating it is deemed substantially equivalent to a legally marketed predicate device for orthopedic applications. This means it has undergone FDA review for safety and effectiveness in total hip arthroplasty procedures, but purchasers or clinicians should confirm compliance with the manufacturer’s instructions and sterile handling protocols to ensure proper use.