TriVerse Total Knee Replacement System— 510(k) K222380

Name: FDA 510(k) clearance K222380
Creator: U.S. Food and Drug Administration
Published: 2022-10-04

Substantially Equivalent

Signature Orthopaedics Pty, Ltd.

FDA 510(k) clearance K222380 for TriVerse Total Knee Replacement System, Substantially Equivalent on 2022-10-04. Applicant: Signature Orthopaedics Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Signature Orthopaedics Pty, Ltd.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2022-08-05
Decision date: 2022-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lane Cove West, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K261563 — Freedom Total Knee System (E-Poly Tibial Liners)2026-08-07
K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)2026-07-31
K261734 — Klassic Infection Spacer System2026-07-23
K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
K261032 — NovoKnee (SteriKnee)2026-04-27

More clearances from Signature Orthopaedics Pty, Ltd.

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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

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.