Unity Total Knee System 112.120.18

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05055343872024 UDI-DI	Date17 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK113060	Date10 Sep 2012Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05055343872024
FDA 510(k) database 510(k) number K113060

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

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Unity Total Knee System
Generic name: Knee arthroplasty wedge
Model / Ref / Catalog: 112.120.18
Description: Unity Tibia Augment 5mm Size 9

Primary DI / UDI-DI: 05055343872024
510(k) Number: K113060
FDA product code: JWH
GMDN term: Knee arthroplasty wedge

Device class: Class II
Regulation number: 888.3560
GUDID distribution status: In Commercial Distribution

Sterilisation method: Radiation Sterilization

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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