OPTIMIZED ORTHO PTY LTD

FDA Device Registration & Listing · Sydney New South Wales, AU · Registration 3012916784

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
3012916784
FEI Number
3012916784
Entity Name
OPTIMIZED ORTHO PTY LTD
City/State/Country
Sydney New South Wales, AU
Establishment Address
17 Bridge Street, Sydney New South Wales 2073, AU
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Corin Group (Owner Number: 9012268)
Owner / Operator Contact Address
THE CORINIUM CENTRE, --, CIRENCESTER, GB-GLS GL7 1YJ, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K192656
PMA Number
N/A

All Registered Proprietary Names

Optimized Position System Functional Hip Analysis (OPS FHA) Optimized Positioning System (OPS) Surgical Instrument Optimized Positioning System (OPS™) Plan Optimized Positioning System (OPS) Plan Optimized Positioning System (OPS) ReView Optimized Positioning System (OPS) Femoral Optimized Positioning System (OPS) Femoral Optimized Positioning System (OPS) Insight

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 2025-12-31
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2025-12-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-31
PLW Acetabular Cup Orientation System Orthopedic Class 2 888.3350 2025-12-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-31
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2025-12-31
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-08-13
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-12-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-31
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-12-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-31
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-12-31
PLW Acetabular Cup Orientation System Orthopedic Class 2 888.3350 2025-12-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-31
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2025-12-31
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2025-12-31
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2025-12-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-31
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2025-12-31
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2025-12-31
PLW Acetabular Cup Orientation System Orthopedic Class 2 888.3350 2025-12-31
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2025-12-31
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-12-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-12-31
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-12-31

Official Correspondent

Aaron Brunt

US Agent Details

Lucinda Gerber Business: Corin USA Email: lucinda.gerber@coringroup.com Phone: (772) 3212478

Related Public Records

Same Entity

Corin Group
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013682146 OMNIlife science, Inc. Milpitas, CA, US
9614209 Corin Limited CIRENCESTER Gloucestershire, GB
1226188 OMNIlifeScience, Inc. Raynham, MA, US

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-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011 Depuy Orthopaedics, Inc. 1
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number Establishment Name Location
3021386586 LINCOTEK (WUXI) CO., LTD. Wuxi Jiangsu, CN
3005061536 SYMMETRY MEDICAL MANUFACTURING INC CLAYPOOL, IN, US
3007923096 Changzhou Biomet Medical Devices Co., Ltd. Changzhou City Jiangsu, CN
3005562917 BGS Beta-Gamma-Service GmbH & Co KG Bruchsal Baden-Wurttemberg, DE
1450662 Isomedix Operations, Inc. Libertyville, IL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012916784. Last updated year: 2026. Please use registration number 3012916784 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.