Modular Plus Hip Stem

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K032709 ↗

FDA Product Code

LWJ

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Rt-Plus Modular Cemented Knee Components

  Class II

  FDA 510(k) K003504 Active Cleared 11 May 2001

• Plus Bipolar Prosthesis Cocrmo

  Class II

  FDA 510(k) K982447 Active Cleared 25 Nov 1998

• Tc-Plus Porous Tibial Components

  Class II

  FDA 510(k) K011288 Active Cleared 24 May 2001

• Modification to Slim Gliding Nail System

  Class II

  FDA 510(k) K033763 Active Cleared 18 Dec 2003

• Uc-Plus Solution Unicondylar Knee

  Class II

  FDA 510(k) K032052 Active Cleared 25 Jul 2003

• Pe-Plus Acetabular Cup

  Class II

  FDA 510(k) K992153 Active Cleared 23 Sep 1999

See all devices from Plus Orthopedics →

• What types of bone conditions is the Modular Plus Hip Stem specifically designed to address in the femur during revision surgery?

  The Modular Plus Hip Stem is engineered for cases involving significant bone damage or fracture in the distal femur, where long-segment femoral bone loss requires stable fixation. Its two-part modular design—distal anchorage and proximal revision modules—provides customizable support for complex revision hip arthroplasty scenarios.

• How is the Modular Plus Hip Stem secured in place during surgery, and what makes its connection system unique?

  The stem’s distal and proximal components connect via a multi-stage tapered coupling, which is then secured with a cylindrical screw. The proximal module also features a 12/14 taper, enabling modular head attachment for added flexibility in revision procedures.

• Is the Modular Plus Hip Stem intended for reuse, or is it meant to be used once per patient?

  The Modular Plus Hip Stem is supplied as a sterile, single-use device, meaning each component is designed for one-time surgical use per patient. This aligns with standard orthopedic practice to ensure patient safety and sterility.

• What regulatory pathway does the Modular Plus Hip Stem follow, and what does ‘substantially equivalent’ mean in this context?

  The device follows the FDA’s 510(k) clearance pathway (K032709) with a Special review classification, categorized under product code LWJ. ‘Substantially equivalent’ means the Modular Plus Hip Stem has been determined to have the same intended use and technological characteristics as a predicate device already on the market, ensuring it meets FDA safety and effectiveness standards.