Patient Specific Implant (PSI) Hip Femoral Component

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

510(k) Number

K964395 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Corticellous Bone Screw

  Class II

  FDA 510(k) K953198 Active Cleared 24 Nov 1995

• Unisyn Ha Plasma Modular Hip

  Class II

  FDA 510(k) K062383 Active Cleared 21 Dec 2006

• Consensus Acetablar Shell, Ti Coated

  Class II

  FDA 510(k) K020153 Active Cleared 15 Apr 2002

• Consensus Acetabular Shell System

  Class II

  FDA 510(k) K060635 Active Cleared 28 Apr 2006

• Consensus Acetabular Insert, Cross-Linked Polyethylene

  Class II

  FDA 510(k) K021466 Active Cleared 24 Jul 2002

• Consensus Femoral Component, Porous, Cocr/Ti

  Class II

  FDA 510(k) K983004 Active Cleared 25 Nov 1998

See all devices from Hayes Medical, Inc. →

• What is the Patient Specific Implant PSI Hip Femoral Component used for?

  It is a femoral component designed for use in total hip arthroplasty to replace the hip joint in patients with degenerative joint disease, fracture, or failure of previous arthroplasty, intended for uncemented implantation.

• How is the Patient Specific Implant PSI Hip Femoral Component supplied?

  The device is supplied as a patient-specific implant, meaning it is individually designed and manufactured based on the patient's anatomy for use in total hip arthroplasty.

• Is the Patient Specific Implant PSI Hip Femoral Component intended for cemented or uncemented use?

  It is indicated for uncemented use in total hip arthroplasty, as specified in the device description and regulatory documentation.

• What regulatory pathway was used for the Patient Specific Implant PSI Hip Femoral Component?

  The device received FDA 510(k) clearance (K964395) under product code LZO through a traditional clearance pathway with review by the orthopedic advisory committee.