Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Signature Orthopaedics Pty, Ltd. · Predicate Candidate Screening
44 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
214 daysmedian FDA review time
325 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddb | Signature Orthopaedics Pty, Ltd. | 2026-03-12 | 188 | 0 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 | 85 | 0 |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | 2025-12-16 | 189 | 0 |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-08-07 | 314 | 0 |
| K242674 | Freedom Posterior Cervical Screws | Signature Orthopaedics Pty, Ltd. | 2025-05-13 | 249 | 0 |
| K242477 | Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. | 2025-05-12 | 264 | 0 |
| K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-05-02 | 217 | 0 |
| K243029 | Origin™ TT Stem | Signature Orthopaedics Pty, Ltd. | 2025-03-11 | 165 | 0 |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024-11-25 | 56 | 0 |
| K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | 2024-09-11 | 183 | 0 |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024-08-01 | 50 | 0 |
| K231134 | VerteLoc Spinal System | Signature Orthopaedics Pty, Ltd. | 2024-02-13 | 298 | 0 |
| K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | Signature Orthopaedics Pty, Ltd. | 2023-05-03 | 55 | 0 |
| K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2023-01-13 | 325 | 0 |
| K223062 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2022-11-04 | 35 | 0 |
| K222380 | TriVerse Total Knee Replacement System | Signature Orthopaedics Pty, Ltd. | 2022-10-04 | 60 | 0 |
| K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | 2022-06-16 | 280 | 0 |
| K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), Wo | Signature Orthopaedics Pty, Ltd. | 2022-04-11 | 28 | 0 |
| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2022-01-07 | 214 | 0 |
| K211505 | Encore Hip Stem | Signature Orthopaedics Pty, Ltd. | 2021-09-24 | 133 | 0 |
| K201047 | Fusion Taper System | Signature Orthopaedics Pty, Ltd. | 2021-04-16 | 360 | 0 |
| K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty, Ltd. | 2020-09-21 | 131 | 0 |
| K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr F | Signature Orthopaedics Pty, Ltd. | 2020-08-14 | 415 | 0 |
| K192883 | Spartan Hip Stem | Signature Orthopaedics Pty, Ltd. | 2020-08-05 | 300 | 0 |
| K201951 | Cemented Origin Hip Stem | Signature Orthopaedics Pty, Ltd. | 2020-07-31 | 18 | 0 |
| K192024 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | 2020-06-19 | 326 | 0 |
| K190577 | World Knee Total Knee Systems | Signature Orthopaedics Pty, Ltd. | 2019-11-27 | 266 | 0 |
| K190704 | Signature Ceramic Femoral Head | Signature Orthopaedics Pty, Ltd. | 2019-08-28 | 163 | 0 |
| K181340 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | 2019-02-11 | 266 | 0 |
| K181190 | Pinehurst Anterior Cervical Plate System | Signature Orthopaedics Pty, Ltd. | 2019-01-17 | 258 | 0 |
| K181338 | Imboki Knee Instrument System | Signature Orthopaedics Pty, Ltd. | 2019-01-17 | 241 | 0 |
| K180754 | C-Zero Pedicle Screw System, Freedom Pedicle Screw System | Signature Orthopaedics Pty, Ltd. | 2018-12-07 | 260 | 0 |
| K181530 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2018-10-24 | 135 | 0 |
| K180750 | World Knee System | Signature Orthopaedics Pty, Ltd. | 2018-04-20 | 29 | 0 |
| K163081 | 40-42mm BiPolar Head and 22mm Femoral Head | Signature Orthopaedics Pty, Ltd. | 2018-01-29 | 452 | 0 |
| K172020 | Arlington PLIF/TLIF Cage | Signature Orthopaedics Pty, Ltd. | 2017-11-29 | 147 | 0 |
| K172019 | Brisbane ALIF Device, Gladstone ALIF Device | Signature Orthopaedics Pty, Ltd. | 2017-11-29 | 147 | 0 |
| K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar | Signature Orthopaedics Pty, Ltd. | 2017-08-11 | 232 | 0 |
| K170613 | Genius Total Knee System | Signature Orthopaedics Pty, Ltd. | 2017-07-17 | 138 | 0 |
| K160159 | Active-X Total Knee System | Signature Orthopaedics Pty, Ltd. | 2016-09-06 | 223 | 0 |
| K161155 | Origin Coxa Vara Hip Stem | Signature Orthopaedics Pty, Ltd. | 2016-07-19 | 85 | 0 |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner | Signature Orthopaedics Pty, Ltd. | 2016-06-03 | 217 | 0 |
| K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | 2015-03-17 | 132 | 0 |
| K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR | Signature Orthopaedics Pty, Ltd. | 2012-12-28 | 242 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda