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Unity Total Knee System 112.004.95

by Corin Ltd

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K113060

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055343871423 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113060 Date10 Sep 2012DecidedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0213-2024 FDA Class II initiated 13 Oct 2023
    • Ongoing Z-0214-2024 FDA Class II initiated 13 Oct 2023

    Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

    • Terminated Z-0273-2023 FDA Class II initiated 31 Oct 2022

    The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Unity Total Knee System
Generic name
Knee femur stem prosthesis
Model / Ref / Catalog
112.004.95
Primary DI / UDI-DI
05055343871423
510(k) Number
FDA product code
JWH
GMDN term
Knee femur stem prosthesis
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Related devices

Category: Knee femur stem prosthesis

Cleared under the same submission (K113060)

Show all (12)

Other devices from Corin Ltd

See all devices from Corin Ltd →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (8)

  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No