Revolution External Plating System

510(k) K181630

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

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	NumberK181630	Date29 May 2019Cleared	StatusActive

5 recalls · 3 ongoing · FDA

- Ongoing Z-1649-2022 FDA Class II initiated 28 Dec 2020
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
- Ongoing Z-1280-2022 FDA Class II initiated 14 Aug 2019 on shared 510(k) K181630
Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
- Ongoing Z-1824-2023 FDA Class II initiated 23 Jul 2019
The threads on posts stripping out when tensioned during application process.
- Completed Z-1236-2022 FDA Class II initiated 8 Jun 2020
1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.
- Terminated Z-0318-2020 FDA Class II initiated 10 Oct 2019 on shared 510(k) K181630
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)