SIGNATURE ORTHOPAEDICS PTY LIMITED

FDA Device Registration & Listing · Sydney New South Wales, AU · Registration 3008262872

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008262872
FEI Number
3008262872
Entity Name
SIGNATURE ORTHOPAEDICS PTY LIMITED
City/State/Country
Sydney New South Wales, AU
Establishment Address
7 Sirius Road, Lane Cove West, Sydney New South Wales 2066, AU
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Signature Orthopaedics Pty Limited (Owner Number: 10037793)
Owner / Operator Contact Address
7 Sirius Road, Lane Cove West, AU-NSW 2066, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201951
PMA Number
N/A

All Registered Proprietary Names

SignaSure Dual Mobility System Pinehurst Anterior Cervical Plate System Evolve AP Cup Brisbane ALIF Cage Gladstone ALIF Cage Rx Knee System Shoulder Anchors Retractor Genius Total Knee System PureGenius Total Knee System Genius Total Knee Trial Instruments Crescendo Total Knee System BIOLOX Forte Encina HA Femoral Stem Standard Offset Collared Manza Polyethylene Liner Manza Screws Logical Acetabular Liner Logical G Series Cup Apex Hole Cover BIOLOX Delta Aria Stem Encina HA Femoral Stem Standard Offset NEO-T Stem Tryon Liner Encina Taper Femoral Stem High Offset Encina HA Femoral Stem High Offset Femoral Head CoCr Head Manza Hole Cover Logical Bone Screw Kratos Stem Manza Heads Encina Taper Femoral Stem Standard Offset Logical PX Series Logical Hole Cover Origin Stem Tryon Acetabular Cup Fixation Screw Sirocco Stem Stratus Stem Vento Cup Vento Fixation Screw Cancellous Bone Screw Ceramic Head Vento XLPE Liner Logical XLPE Liner Cemented TSI Hip Stem Spartan World Knee Slap Hammer SignaLoc Screw PEEK RCI Screw Biocomposite Screw DM Sleeve Driver Imboki Knee Instrument System The Beeley Trocar Dymaxeon Spine System Evolve Helios Stem Pelion Stem Pegasus Stem Bipolar Head Remedy Stem Evolve Masters Stem Distal Centraliser Cement Plug SKYLON Stem Encina Taper A Xerxes Hip Stem TriVerse Tray World Knee World Knee System Freedom Posterior Cervical Screw Cemented TSI Hip Stem Fusion Taper System Osteosynthesis Plate System Liner Impactor World Hip System Patella Caliper Dymaxeon Spine System TriVerse I-Beam Osteotome TriVerse Fin Punch TriVerse I-Beam Solid Punch Trial Devices Everglade Hip Stem Hammers Stylus Currette Chisels Calipers Guides Clamps Cambridge Partial Knee TSI Stem Origin-NS World Total Knee System SignaSure Dual Mobility System Cemented Origin Hip Stem

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-01-17
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2023-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-01-20
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-06-01
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2026-06-01
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2026-06-01
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-06-01
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-12-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-10-29
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-09-29
GAD Retractor General, Plastic Surgery Class 1 878.4800 2017-10-09
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-07-17
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2013-01-17
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2013-01-17
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-08-03
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-08-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-12-20
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2023-02-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-05-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-05-17
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2023-01-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-01-23
FBM Cannula And Trocar, Suprapubic, Non-Disposable Gastroenterology, Urology Class 1 876.5090 2013-01-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-09-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-09-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-09-13
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2014-08-11
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2014-08-11
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2014-08-11
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-08-11
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2024-01-17
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2024-01-17
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-01-17
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2023-02-09
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2022-04-20
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2022-04-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-04-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-11-13
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-09-29
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2019-02-18
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-04-20
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-04-20
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-04-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-02-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-02-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2026-02-12
HWA Impactor Orthopedic Class 1 888.4540 2023-01-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2020-09-21
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-09-21
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2020-09-21
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2023-02-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-09-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-09-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-09-13
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2023-02-09
HWT Template Orthopedic Class 1 888.4800 2018-09-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-09-27
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-09-27
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2018-09-18
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2026-02-11
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2013-12-11
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2019-12-16
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-12-16
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-01-24
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2022-01-24
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-08-03

Official Correspondent

Declan Brazil

US Agent Details

Jeremy Tincher Email: jeremy@signatureortho.us Phone: (901) 3312747

Related Public Records

Same Entity

Signature Orthopaedics Pty Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014763043 Signature Orthopaedics Europe Ltd Athlone Westmeath, IE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21
K140975 Lima Corporate S.P.A. MASTERSL FEMORAL STEM 2014-06-10
K932222 Dow Corning Wright SLT FEMORAL HEAD 1994-05-27
K910547 Turnkey Intergration USA, Inc. FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) 1991-04-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0001-2019 Smith & Nephew, Inc. 2
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008262872. Last updated year: 2026. Please use registration number 3008262872 when referencing this establishment in official correspondence.
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