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Data / Medical devices / Ireland / Signature Orthopaedics Europe Ltd

Signature Orthopaedics Europe Ltd: FDA-registered device maker in Athlone Westmeath, Ireland, 29 510(k) clearances

Signature Orthopaedics Europe Ltd is registered with the FDA (registration 3014763043) in Athlone Westmeath, Ireland. It lists 31 device types. The FDA files 29 510(k) clearances under its listings, the newest dated March 12, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Signature Orthopaedics Europe Ltd
FDA registration number
3014763043
Address
Unit A, IDA Business & Technology Park, Garrycastle, Athlone Westmeath, Ireland, N37 DY26
Owner or operator
Signature Orthopaedics Pty Limited (10037793)
Roles
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

DeviceProduct codeClassRoleSource
Driver, ProsthesisHWR1Manufacturer, Specification developeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Manufactureraccessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOQG2Manufactureraccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOQI2Manufactureraccessdata.fda.gov
ImpactorHWA1Manufacturer, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Contract manufactureraccessdata.fda.gov
OsteotomeHWM1Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerKWZ2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateMEH2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousMBL2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerHSX2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOIY2Manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Manufactureraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Manufactureraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 12, 2026K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDISubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
December 23, 2025K253239Active-V Total Knee System; World Total Knee SystemMBHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
December 16, 2025K251771Cambridge Partial KneeHSXSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
August 7, 2025K243021Longboard Revision Hip StemLZOSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
May 13, 2025K242674Freedom Posterior Cervical ScrewsNKGSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
May 12, 2025K242477Shoulder Soft Tissue AnchorsMBISubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
March 11, 2025K243029Origin™ TT StemLZOSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
February 6, 2025K241599Signature Osteosynthesis Plate SystemHRSSubstantially EquivalentSignature Orthopaedic Pty , Ltd.accessdata.fda.gov
November 25, 2024K243162World LinerMEHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
September 11, 2024K240683Rx Knee SystemJWHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
February 13, 2024K231134VerteLoc Spinal SystemMQPSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
May 3, 2023K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewMBISubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
January 13, 2023K220495SignaSure Dual Mobility SystemMEHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
November 4, 2022K223062World Total Knee SystemJWHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
October 4, 2022K222380TriVerse Total Knee Replacement SystemJWHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
April 11, 2022K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)JWHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
January 7, 2022K211742SignaSure Dual Mobility SystemMEHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
September 24, 2021K211505Encore Hip StemMEHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
April 16, 2021K201047Fusion Taper SystemLZOSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
September 21, 2020K201278World Hip Stem, World Cup, World LinerMEHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
August 5, 2020K192883Spartan Hip StemLZOSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
November 27, 2019K190577World Knee Total Knee SystemsJWHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
January 29, 2018K16308140-42mm BiPolar Head and 22mm Femoral HeadKWYSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
July 17, 2017K170613Genius Total Knee SystemJWHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
September 6, 2016K160159Active-X Total Knee SystemJWHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
July 19, 2016K161155Origin Coxa Vara Hip StemMEHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
June 3, 2016K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerMEHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov
July 22, 2014K133370REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CELPHSubstantially EquivalentSignature Orthopaedics Pty Limitedaccessdata.fda.gov
December 28, 2012K121297ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARLPHSubstantially EquivalentSignature Orthopaedics Pty, Ltd.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
October 9, 201985121Class IIOngoingEncina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay.accessdata.fda.gov

Compare with other makers

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.