Concept Unicompartmental Knee System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K896648 ↗

FDA Product Code

HSX

Device Class

Class II

Regulation

21 CFR Part 888.3520

Advisory Committee

Orthopedic

FDA Decision

SN

• Shutt Universal Stress Post

  Class I

  FDA 510(k) K833624 Active Cleared 28 Nov 1983

• Dental Stain Remover

  Class I

  FDA 510(k) K761352 Active Cleared 3 Jan 1977

• Thornton Anterior Chamber Irrigator

  Class I

  FDA 510(k) K771732 Active Cleared 28 Sep 1977

• Esa Camera

  Class I

  FDA 510(k) K823516 Active Cleared 30 Dec 1982

• Vitreous Suction Cutter

  Class II

  FDA 510(k) K761353 Active Cleared 5 Jan 1977

• Suture Retention Clamp

  Class I

  FDA 510(k) K771554 Active Cleared 2 Sep 1977

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