40-42mm BiPolar Head and 22mm Femoral Head— 510(k) K163081

Clearance details

Applicant

Signature Orthopaedics Pty, Ltd.

Product code

Code KWY

Device class

Class 2

Regulation

21 CFR 888.3390

Advisory panel

Orthopedic

Date received

2016-11-03

Decision date

2018-01-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lane Cove West, AU

• K253357 — b-ONE® Bipolar Head2026-04-13
• K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip)2025-08-25
• K231526 — CORAIL Cemented Femoral Stem2023-12-19
• K223441 — SpaceFlex Acetabular Cup2023-03-23
• K221794 — Vario-Cup System2022-07-20

• K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head2026-03-12
• K253239 — Active-V Total Knee System; World Total Knee System2025-12-23
• K251771 — Cambridge Partial Knee2025-12-16
• K243021 — Longboard Revision Hip Stem2025-08-07
• K242674 — Freedom Posterior Cervical Screws2025-05-13

Death

3

Injury

2,049

Total

2,052

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →