Posterior Stabilized Apollo Knee System

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

510(k) Number

K935789 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• Drg Cemeted Stem

  Class II

  FDA 510(k) K920003 Active Cleared 13 Mar 1992

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  Class I

  FDA 510(k) K895121 Active Cleared 11 Sep 1989

• Intermedics High Tibial Osteotomy System

  Class II

  FDA 510(k) K892228 Active Cleared 6 Oct 1989

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  Class II

  FDA 510(k) K873815 Active Cleared 28 Oct 1987

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  Class II

  FDA 510(k) K935802 Active Cleared 22 May 1995

• Zweymueller Sl Femoral Hip Stem

  Class II

  FDA 510(k) K962101 Active Cleared 19 Aug 1996

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• What is the Posterior Stabilized Apollo Knee System used for?

  It is a prosthesis designed for use in knee arthroplasty procedures to restore joint function in patients requiring knee replacement.

• How is the Posterior Stabilized Apollo Knee System supplied and is it reusable?

  The device is supplied as a sterile, single-use implant intended for surgical implantation in a hospital or clinical setting and is not designed for reuse.

• What regulatory pathway was used for the Posterior Stabilized Apollo Knee System?

  It received FDA 510(k) clearance under product code JWH, with a decision date of February 6, 1995, and is regulated as a Class II medical device.