Novae Sunfit Th Dual Mobility Acetabular Cup Model Sunfit Th (Metal-Back), Novae E Th Dual Mobility Acetabular Cup Model

510(k) K111572

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK111572	Date29 Aug 2011Cleared	StatusActive

5 recalls · FDA

3 recalls, same reason
- Terminated Z-0922-2021 FDA Class II initiated 21 Dec 2020
- Terminated Z-0921-2021 FDA Class II initiated 21 Dec 2020
- Terminated Z-0920-2021 FDA Class II initiated 21 Dec 2020
Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
2 recalls, same reason
- Terminated Z-2479-2019 FDA Class II initiated 23 Jul 2019
- Terminated Z-2480-2019 FDA Class II initiated 23 Jul 2019
Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

1 jurisdiction

United States — FDA 510(k) Active

510(k)