Company · AU
Signature Orthopaedics Pty, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 10 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 8 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 8 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 |
| NKG | Posterior Cervical Screw System | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2026 | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head Signature Orthopaedics Pty, Ltd., AU | JDI |
| Dec 23, 2025 | K253239 | Active-V Total Knee System; World Total Knee System Signature Orthopaedics Pty, Ltd., AU | MBH |
| Dec 16, 2025 | K251771 | Cambridge Partial Knee Signature Orthopaedics Pty, Ltd., AU | HSX |
| Aug 7, 2025 | K243021 | Longboard Revision Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| May 13, 2025 | K242674 | Freedom Posterior Cervical Screws Signature Orthopaedics Pty, Ltd., AU | NKG |
| May 12, 2025 | K242477 | Shoulder Soft Tissue Anchors Signature Orthopaedics Pty, Ltd., AU | MBI |
| May 2, 2025 | K243043 | Origin Cemented Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Mar 11, 2025 | K243029 | Origin TT Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Nov 25, 2024 | K243162 | World Liner Signature Orthopaedics Pty, Ltd., AU | MEH |
| Sep 11, 2024 | K240683 | Rx Knee System Signature Orthopaedics Pty, Ltd., AU | JWH |
| Aug 1, 2024 | K241690 | Logical Liner; World Liner; World Knee Patella Signature Orthopaedics Pty, Ltd., AU | MEH |
| Feb 13, 2024 | K231134 | VerteLoc Spinal System Signature Orthopaedics Pty, Ltd., AU | MQP |
| May 3, 2023 | K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw Signature Orthopaedics Pty, Ltd., AU | MBI |
| Jan 13, 2023 | K220495 | SignaSure Dual Mobility System Signature Orthopaedics Pty, Ltd., AU | MEH |
| Nov 4, 2022 | K223062 | World Total Knee System Signature Orthopaedics Pty, Ltd., AU | JWH |
| Oct 4, 2022 | K222380 | TriVerse Total Knee Replacement System Signature Orthopaedics Pty, Ltd., AU | JWH |
| Jun 16, 2022 | K212870 | TLC Unicompartmental Knee System Signature Orthopaedics Pty, Ltd., AU | HSX |
| Apr 11, 2022 | K220737 | World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) Signature Orthopaedics Pty, Ltd., AU | JWH |
| Jan 7, 2022 | K211742 | SignaSure Dual Mobility System Signature Orthopaedics Pty, Ltd., AU | MEH |
| Sep 24, 2021 | K211505 | Encore Hip Stem Signature Orthopaedics Pty, Ltd., AU | MEH |
| Apr 16, 2021 | K201047 | Fusion Taper System Signature Orthopaedics Pty, Ltd., AU | LZO |
| Sep 21, 2020 | K201278 | World Hip Stem, World Cup, World Liner Signature Orthopaedics Pty, Ltd., AU | MEH |
| Aug 14, 2020 | K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head Signature Orthopaedics Pty, Ltd., AU | LPH |
| Aug 5, 2020 | K192883 | Spartan Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Jul 31, 2020 | K201951 | Cemented Origin Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Jun 19, 2020 | K192024 | Cemented TSI Hip Stem Signature Orthopaedics Pty, Ltd., AU | LZO |
| Nov 27, 2019 | K190577 | World Knee Total Knee Systems Signature Orthopaedics Pty, Ltd., AU | JWH |
| Aug 28, 2019 | K190704 | Signature Ceramic Femoral Head Signature Orthopaedics Pty, Ltd., AU | LZO |
| Feb 11, 2019 | K181340 | Cemented TSI Hip Stem Signature Orthopaedics Pty, Ltd., AU | JDI |
| Jan 17, 2019 | K181338 | Imboki Knee Instrument System Signature Orthopaedics Pty, Ltd., AU | JWH |
| Jan 17, 2019 | K181190 | Pinehurst Anterior Cervical Plate System Signature Orthopaedics Pty, Ltd., AU | KWQ |
| Dec 7, 2018 | K180754 | C-Zero Pedicle Screw System, Freedom Pedicle Screw System Signature Orthopaedics Pty, Ltd., AU | NKB |
| Oct 24, 2018 | K181530 | World Total Knee System Signature Orthopaedics Pty, Ltd., AU | JWH |
| Apr 20, 2018 | K180750 | World Knee System Signature Orthopaedics Pty, Ltd., AU | JWH |
| Jan 29, 2018 | K163081 | 40-42mm BiPolar Head and 22mm Femoral Head Signature Orthopaedics Pty, Ltd., AU | KWY |
| Nov 29, 2017 | K172020 | Arlington PLIF/TLIF Cage Signature Orthopaedics Pty, Ltd., AU | MAX |
| Nov 29, 2017 | K172019 | Brisbane ALIF Device, Gladstone ALIF Device Signature Orthopaedics Pty, Ltd., AU | OVD |
| Aug 11, 2017 | K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System Signature Orthopaedics Pty, Ltd., AU | KWQ |
| Jul 17, 2017 | K170613 | Genius Total Knee System Signature Orthopaedics Pty, Ltd., AU | JWH |
| Sep 6, 2016 | K160159 | Active-X Total Knee System Signature Orthopaedics Pty, Ltd., AU | JWH |
| Jul 19, 2016 | K161155 | Origin Coxa Vara Hip Stem Signature Orthopaedics Pty, Ltd., AU | MEH |
| Jun 3, 2016 | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Aceta Signature Orthopaedics Pty, Ltd., AU | MEH |
| Mar 17, 2015 | K143184 | Evolve UniPolar Head Signature Orthopaedics Pty, Ltd., AU | KWL |
| Jul 22, 2014 | K133370 | REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE Signature Orthopaedics Pty Limited, AU | LPH |
| Dec 28, 2012 | K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR Signature Orthopaedics Pty, Ltd., AT | LPH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||