Hip Joint Metal/Polymer Semi-Constrained Prothesis

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

510(k) Number

K921525 ↗

FDA Product Code

LPH

Device Class

Class II

Regulation

21 CFR Part 888.3358

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• LSF HA Coated Femoral Hip

  Class II

  FDA 510(k) K915617 Active Cleared 28 May 1992

• Lsf Cemented Femoral Hip

  Class II

  FDA 510(k) K902727 Active Cleared 9 Aug 1990

• Communitrach Tube

  Class II

  FDA 510(k) K823291 Active Cleared 8 Jan 1983

• Implant Technology Bone Cement Extractor

  Class II

  FDA 510(k) K891472 Active Cleared 2 May 1989

• Communi-Trach Tube

  Class II

  FDA 510(k) K841546 Active Cleared 30 Apr 1984

• Lsf Total Hip System - Muller-Type Acetabular Cup

  Class II

  FDA 510(k) K920021 Active Cleared 25 Mar 1992

See all devices from Implant Technology, Inc. →

• What is the purpose of the hip joint metal/polymer semi-constrained prosthesis?

  This device is intended to be implanted to replace a hip joint. It limits translation and rotation in one or more planes through the geometry of its articulating surfaces, providing stability to the joint replacement.

• What configurations are available for this hip prosthesis?

  The device is available in both cemented and uncemented configurations, with some models offering porous-coated options. The specific configuration depends on the surgical needs and the particular model selected.

• Is this device single-use or reusable?

  The hip joint prosthesis is supplied sterile and may be either single-use or reusable depending on the specific model. Users should refer to the manufacturer's instructions for the particular model regarding reuse protocols.

• What are the storage requirements for this implant?

  This device requires specific storage conditions as per the manufacturer's instructions. Proper storage is essential to maintain the integrity of the implant until its use in surgical procedures.