510(k) K212512

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

April 28, 2022

Date Received

August 10, 2021

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

Device Class

Class II

Regulation Number

888.3310

Review Panel

OR

Submission Type

For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.