Data / Medical devices / Australia / Signature Orthopaedics Pty Limited
Signature Orthopaedics Pty Limited: FDA-registered device maker in Sydney New South Wales, Australia, 49 510(k) clearances
Signature Orthopaedics Pty Limited is registered with the FDA (registration 3008262872) in Sydney New South Wales, Australia. It lists 40 device types. The FDA files 49 510(k) clearances under its listings, the newest dated March 12, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008262872
- Address
- 7 Sirius Road Lane Cove West, Sydney New South Wales, Australia, 2066
- Owner or operator
- Signature Orthopaedics Pty Limited (10037793)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- August 16, 2011
- Registered through
- 2026
- Brand names listed
- Acetabular Reamer, Active-V Knee, Active-X Cemented Femoral Component, Active-X Cemented Tibial Component, Active-X Inlay Patella Component, Active-X Patella Component, Active-X Regular Meniscal Insert, Active-X Ultracongruent Meniscal Insert and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2026 | K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | JDI | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| December 23, 2025 | K253239 | Active-V Total Knee System; World Total Knee System | MBH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| December 16, 2025 | K251771 | Cambridge Partial Knee | HSX | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| August 7, 2025 | K243021 | Longboard Revision Hip Stem | LZO | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| May 13, 2025 | K242674 | Freedom Posterior Cervical Screws | NKG | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| May 12, 2025 | K242477 | Shoulder Soft Tissue Anchors | MBI | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| March 11, 2025 | K243029 | Origin TT Stem | LZO | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| February 6, 2025 | K241599 | Signature Osteosynthesis Plate System | HRS | Substantially Equivalent | Signature Orthopaedic Pty , Ltd. | accessdata.fda.gov |
| November 25, 2024 | K243162 | World Liner | MEH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| September 11, 2024 | K240683 | Rx Knee System | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| August 1, 2024 | K241690 | Logical Liner; World Liner; World Knee Patella | MEH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| February 13, 2024 | K231134 | VerteLoc Spinal System | MQP | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| May 3, 2023 | K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | MBI | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| January 13, 2023 | K220495 | SignaSure Dual Mobility System | MEH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| November 4, 2022 | K223062 | World Total Knee System | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| October 4, 2022 | K222380 | TriVerse Total Knee Replacement System | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| April 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) | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| January 7, 2022 | K211742 | SignaSure Dual Mobility System | MEH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| September 24, 2021 | K211505 | Encore Hip Stem | MEH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| April 16, 2021 | K201047 | Fusion Taper System | LZO | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| September 21, 2020 | K201278 | World Hip Stem, World Cup, World Liner | MEH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| August 5, 2020 | K192883 | Spartan Hip Stem | LZO | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| July 31, 2020 | K201951 | Cemented Origin Hip Stem | LZO | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| June 19, 2020 | K192024 | Cemented TSI Hip Stem | LZO | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| November 27, 2019 | K190577 | World Knee Total Knee Systems | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| February 11, 2019 | K181340 | Cemented TSI Hip Stem | JDI | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| January 17, 2019 | K181338 | Imboki Knee Instrument System | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| January 17, 2019 | K181190 | Pinehurst Anterior Cervical Plate System | KWQ | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| December 7, 2018 | K180754 | C-Zero Pedicle Screw System, Freedom Pedicle Screw System | NKB | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| October 24, 2018 | K181530 | World Total Knee System | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| April 20, 2018 | K180750 | World Knee System | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| January 29, 2018 | K163081 | 40-42mm BiPolar Head and 22mm Femoral Head | KWY | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| November 29, 2017 | K172020 | Arlington PLIF/TLIF Cage | MAX | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| November 29, 2017 | K172019 | Brisbane ALIF Device, Gladstone ALIF Device | OVD | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| August 11, 2017 | K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System | KWQ | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| July 17, 2017 | K170613 | Genius Total Knee System | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| September 6, 2016 | K160159 | Active-X Total Knee System | JWH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| July 19, 2016 | K161155 | Origin Coxa Vara Hip Stem | MEH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| June 3, 2016 | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner | MEH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| March 17, 2015 | K143184 | Evolve UniPolar Head | KWL | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| July 22, 2014 | K133370 | REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE | LPH | Substantially Equivalent | Signature Orthopaedics Pty Limited | accessdata.fda.gov |
| December 28, 2012 | K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR | LPH | Substantially Equivalent | Signature Orthopaedics Pty, Ltd. | accessdata.fda.gov |
| March 24, 2011 | K110555 | ARCOMXL ACTIVE ARTICULATION | LPH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 1, 2011 | K102172 | MSA HIP SYSTEM | MEH | Substantially Equivalent | Global Manufacturing Technology | accessdata.fda.gov |
| June 29, 2007 | K071053 | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | KXA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 31, 2006 | K062995 | M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 1, 2004 | K042037 | M2A MAGNUM SYSTEM | KWA | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 11, 2002 | K023188 | PRESS-FIT HEAD RESURFACING DEVICE | KXA | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| June 26, 2002 | K021799 | CEMENTED FEMORAL HEAD RESURFING DEVICE | KXA | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 20, 2021 | 87862 | Class II | Terminated | Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant. | Product mislabeled, with the incorrect product inside the package. | accessdata.fda.gov |
| December 10, 2018 | 81967 | Class II | Terminated | Genius Knee Cemented Tibial Component Product Usage: Knee replacement component | Product mix up | accessdata.fda.gov |
| February 2, 2018 | 79219 | Class II | Terminated | Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem tr | This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved. | accessdata.fda.gov |
Compare with other makers
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Tape, Measuring, Rulers And Calipers
Updated March 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.