510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Signature Orthopaedics Pty Limited

Sydney New South Wales, AU

SIGNATURE ORTHOPAEDICS PTY LIMITED appears in FDA device records in Sydney New South Wales, AU. FDA records list 45 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
45
PMA records
0
Recall records
4
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Signature Orthopaedics Pty Limited carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Signature Orthopedics Pty Limitedenforcement report, recall

510(k) clearance history

FDA records hold 45 510(k) clearances for Signature Orthopaedics Pty Limited between 2012 and 2026. The busiest year on record is 2025, with 7. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Signature Orthopaedics Pty Limited, by decision year
YearClearances
20121
20141
20151
20163
20174
20184
20195
20205
20212
20225
20232
20244
20257
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDISubstantially Equivalent
K253239Active-V Total Knee System; World Total Knee SystemMBHSubstantially Equivalent
K251771Cambridge Partial KneeHSXSubstantially Equivalent
K243021Longboard Revision Hip StemLZOSubstantially Equivalent
K242674Freedom Posterior Cervical ScrewsNKGSubstantially Equivalent
K242477Shoulder Soft Tissue AnchorsMBISubstantially Equivalent
K243043Origin™ Cemented Hip StemLZOSubstantially Equivalent
K243029Origin™ TT StemLZOSubstantially Equivalent
K243162World LinerMEHSubstantially Equivalent
K240683Rx Knee SystemJWHSubstantially Equivalent
K241690Logical Liner; World Liner; World Knee PatellaMEHSubstantially Equivalent
K231134VerteLoc Spinal SystemMQPSubstantially Equivalent
K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewMBISubstantially Equivalent
K220495SignaSure Dual Mobility SystemMEHSubstantially Equivalent
K223062World Total Knee SystemJWHSubstantially Equivalent
K222380TriVerse Total Knee Replacement SystemJWHSubstantially Equivalent
K212870TLC Unicompartmental Knee SystemHSXSubstantially Equivalent
K220737World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)JWHSubstantially Equivalent
K211742SignaSure Dual Mobility SystemMEHSubstantially Equivalent
K211505Encore Hip StemMEHSubstantially Equivalent
K201047Fusion Taper SystemLZOSubstantially Equivalent
K201278World Hip Stem, World Cup, World LinerMEHSubstantially Equivalent
K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadLPHSubstantially Equivalent
K192883Spartan Hip StemLZOSubstantially Equivalent
K201951Cemented Origin Hip StemLZOSubstantially Equivalent
K192024Cemented TSI Hip StemLZOSubstantially Equivalent
K190577World Knee Total Knee SystemsJWHSubstantially Equivalent
K190704Signature Ceramic Femoral HeadLZOSubstantially Equivalent
K181340Cemented TSI Hip StemJDISubstantially Equivalent
K181338Imboki Knee Instrument SystemJWHSubstantially Equivalent
K181190Pinehurst Anterior Cervical Plate SystemKWQSubstantially Equivalent
K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemNKBSubstantially Equivalent
K181530World Total Knee SystemJWHSubstantially Equivalent
K180750World Knee SystemJWHSubstantially Equivalent
K16308140-42mm BiPolar Head and 22mm Femoral HeadKWYSubstantially Equivalent
K172020Arlington PLIF/TLIF CageMAXSubstantially Equivalent
K172019Brisbane ALIF Device, Gladstone ALIF DeviceOVDSubstantially Equivalent
K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate SystemKWQSubstantially Equivalent
K170613Genius Total Knee SystemJWHSubstantially Equivalent
K160159Active-X Total Knee SystemJWHSubstantially Equivalent
K161155Origin Coxa Vara Hip StemMEHSubstantially Equivalent
K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerMEHSubstantially Equivalent
K143184Evolve UniPolar HeadKWLSubstantially Equivalent
K133370REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CELPHSubstantially Equivalent
K121297ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARLPHSubstantially Equivalent

Registered establishments

FDA registered establishments for Signature Orthopaedics Pty Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30082628723008262872SIGNATURE ORTHOPAEDICS PTY LIMITED7 Sirius Road, Sydney New South Wales 2066 AU2026and 30 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1694-2021Logical 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.Class IITerminated
Z-0834-2019Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement componentProduct mix upClass IITerminated
Z-0833-2019Genius Knee Cemented Tibial Component Product Usage: Knee replacement componentProduct mix upClass IITerminated
Z-0920-2018Signature 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 trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis Inflammatory joint disease including rheumatoid arthritis Correction of functional deformity including congenital hip dysplasia Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacementThis 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.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain