Second Generation Knee System, Femoral, Patellar

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

510(k) Number

K895145 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• Tibial Tray Pmma Plug for Plus/Axiom Total Knee Sy

  Class II

  FDA 510(k) K911198 Active Cleared 23 May 1991

• Titanium Nitride Coated Hemi-Head Component

  Class II

  FDA 510(k) K924050 Active Cleared 25 Aug 1993

• Hybrid Femoral Stem, Perfecta Total Hip System

  Class II

  FDA 510(k) K925536 Active Cleared 7 Jan 1994

• Lea Plaza Spinal Frame System

  Class II

  FDA 510(k) K884585 Active Cleared 27 Jan 1989

• Intraform Total Hip System

  Class II

  FDA 510(k) K890742 Active Cleared 10 May 1989

• Omc Orthomet Cannulated Screw

  Not classified

  FDA 510(k) K862157 Active Cleared 29 Aug 1986

See all devices from Orthomet, Inc. →

• What is the Second Generation Knee System, Femoral, Patellar used for?

  This device is a semi-constrained knee prosthesis designed to replace damaged knee joints caused by degenerative or traumatic conditions. Its polymer-metal-polymer construction articulates to limit movement in specific planes, restoring stability and function while alleviating pain. It is intended for surgical implantation by orthopedic specialists to improve mobility in patients with severe knee joint issues.

• How is the Second Generation Knee System, Femoral, Patellar supplied and implanted?

  The system is supplied as a reusable surgical implant and requires cement fixation during placement. It is intended for use in hospital operating rooms under sterile conditions by orthopedic specialists. The cement ensures secure attachment of the prosthesis to the patient’s bone, providing stability post-surgery.

• Is the Second Generation Knee System, Femoral, Patellar single-use or reusable?

  The device is designed as a reusable surgical implant, meaning it is intended for use in multiple patients after proper cleaning, sterilization, and inspection. However, its reuse must comply with strict medical device sterility and surgical protocol standards to ensure safety and efficacy.

• What regulatory approval does this knee prosthesis hold?

  The Second Generation Knee System, Femoral, Patellar holds FDA 510(k) clearance under the reference number K895145. This clearance was granted by the Orthopedic Advisory Committee, affirming its substantial equivalence for specific indications in knee joint replacement procedures.

• How should the Second Generation Knee System, Femoral, Patellar be stored and handled?

  Storage and handling must adhere to medical device sterility and surgical protocol standards to maintain safety and efficacy. The device should be kept in a clean, controlled environment, protected from contamination, and prepared for use in sterile operating room conditions prior to implantation.