Origin Coxa Vara Hip Stem— 510(k) K161155

Clearance details

Applicant

Signature Orthopaedics Pty, Ltd.

Product code

Code MEH

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

2016-04-25

Decision date

2016-07-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lane Cove West, AU

• K261576 — Icona Hip Stem2026-08-10
• K250375 — Allure Hip Stem and Intramedullary Plugs2025-11-05
• K251166 — Mfinity Femoral System2025-06-13
• K251052 — Trivicta® Hip Stem2025-05-22
• K242315 — Resolve Modular Revision Hip Stem2025-05-01

• 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

Injury

2,021

Total

2,021

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 →

• Z-1568-2020 — Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934Class II·Ongoing·Signature Orthopaedics Europe Ltd·20191009

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161155.