# Signature Orthopaedics Pty, Ltd.

- Location (FDA's records): Lane Cove West, AU
- FDA decisions: 45 (2012–2026): 45 510(k) clearances
- Names in FDA's records: Signature Orthopaedics Pty, Ltd. (44); Signature Orthopaedics Pty Limited (1)
- Product codes: JWH (10), MEH (8), LZO (8), LPH (3), MBI (2), KWQ (2), HSX (2), MAX (1), NKB (1), NKG (1), OVD (1), KWY (1)
- 510(k) review time since 2016: median 186 days, against 111 for FDA's reviews in the same codes and years (9 of 38 faster)
- Predicates its devices cite: 153 (51 its own); citations of its devices by later devices: 61 (51 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- DePuy Orthopaedics, Inc.: 12 (https://510kreport.com/company/depuy-orthopaedics)
- Smith & Nephew, Inc.: 9 (https://510kreport.com/company/smith-nephew)
- Howmedica Osteonics Corp.: 9 (https://510kreport.com/company/howmedica-osteonics)
- Encore Medical L.P.: 6 (https://510kreport.com/company/encore-medical)
- Encore Orthopedics, Inc.: 5 (https://510kreport.com/company/encore-orthopedics)
- Depuy, Inc.: 4 (https://510kreport.com/company/depuy)
- Depuy Spine, Inc.: 4 (https://510kreport.com/company/depuy-spine)
- Serf: 4 (https://510kreport.com/company/serf)

## Firms that cite its devices most
- Xerxes Arthopedix, LLC: 4 (https://510kreport.com/company/xerxes-arthopedix)
- Waldemar Link GmbH & Co. KG: 1 (https://510kreport.com/company/waldemar-link)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Microport Orthopedics, Inc.: 1 (https://510kreport.com/company/microport-orthopedics)
- The General Hospital Corporation, d/b/a Massachusetts: 1 (https://510kreport.com/company/general-hospital-d-b-a-massachusetts)
- Maxx Orthopedics, Inc.: 1 (https://510kreport.com/company/maxx-orthopedics)
- Total Joint Orthopedics, Inc.: 1 (https://510kreport.com/company/total-joint-orthopedics)

## Its most-cited devices
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular (2012), cited by 12
- K181530: World Total Knee System (2018), cited by 5
- K180750: World Knee System (2018), cited by 4
- K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE (2014), cited by 4
- K153131: Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner (2016), cited by 3
- K201278: World Hip Stem, World Cup, World Liner (2020), cited by 3

## Recent decisions
- K252824: Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (Mar 12, 2026)
- K253239: Active-V Total Knee System; World Total Knee System (Dec 23, 2025)
- K251771: Cambridge Partial Knee (Dec 16, 2025)
- K243021: Longboard Revision Hip Stem (Aug 7, 2025)
- K242674: Freedom Posterior Cervical Screws (May 13, 2025)
- K242477: Shoulder Soft Tissue Anchors (May 12, 2025)
- K243043: Origin™ Cemented Hip Stem (May 2, 2025)
- K243029: Origin™ TT Stem (Mar 11, 2025)

Source page: https://510kreport.com/company/signature-orthopaedics