FDA.reportPublic FDA data

Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral

Primary DI
09351327000053
Brand
Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral
Company
OPTIMIZED ORTHO PTY LTD
Model
1248-1500, 1248-1700, 1250-1100
Device description
Patient Specific Acetabular Guide, Trial Acetabulum and Patient Specific Femoral Guide
Published
2019-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152893000
K181061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152893000Corin Optimized Positioning System (OPS)Corin USA2016-06-03LZO
K181061000Corin Optimized Positioning System (OPS) FemoralCorin USA2018-09-07LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351327000053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351327000053093513270000539351327000053

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made orthopaedic surgical guide, non-sterileA non-sterile, custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
745735175
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351327000374OPS™ FHA1205-00012019-11-11
09351327000077Optimized Positioning System (OPS) Plan1250-13002019-04-23
09351327000091Optimized Positioning System (OPS) Plan 1250-1300 2019-04-23
09351327001302Optimized Ortho Positioning (OPS) System1248-50002022-05-26
09351327001364Optimized Ortho Positioning (OPS) System1248-50012022-05-26
09351327000848OPSInsight™1.21200-00002021-03-16
09351327000022Optimized Positioning System (OPS)1248-1500 and 1248-17002019-04-18
09351327000060Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral1248-1500, 1248-1700, 1250-1100,1250-12002019-04-18
09351327000084Optimized Positioning System (OPS) Femoral 1250-1100,1250-12002019-04-18
09351327000008Optimized Ortho Positioning (OPS) System 1248-15002019-04-12
09351327000015Optimized Ortho Positioning (OPS) System 1248-17002019-04-12
09351327000039Optimized Ortho Positioning (OPS) Femoral1250-11002019-04-12
09351327000046Optimized Ortho Positioning (OPS) Femoral1250-12002019-04-12
09351327000695OPS1248-00722020-02-17
09351327000701OPS1248-00412020-02-17
09351327000718OPS1248-00422020-02-17
09351327000725OPS1248-00432020-02-17
09351327000732OPS1248-00762020-02-17
09351327000749OPS1248-00772020-02-17
09351327000756OPS1248-00832020-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542788314AMIStem-PMedacta International SALZO2026-06-08
07630542788321AMIStem-PMedacta International SALZO2026-06-08
07630542788338AMIStem-PMedacta International SALZO2026-06-08
07630542788345AMIStem-PMedacta International SALZO2026-06-08
07630542788352AMIStem-PMedacta International SALZO2026-06-08
07630542788369AMIStem-PMedacta International SALZO2026-06-08
07630542788376AMIStem-PMedacta International SALZO2026-06-08
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812210InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01