FDA.reportPublic FDA data

Zimmer Patient Specific Instruments

Primary DI
E314005970000170
Brand
Zimmer Patient Specific Instruments
Company
Materialise NV
Model
00-5970-000-17
Catalog number
00-5970-000-17
Device description
NexGen® LPS Pin Guides (Femur and Tibia) CT
Published
2017-07-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113829000ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNEMaterialise NV2012-04-02JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E31400597000017PreviousHIBCC0
E314005970000170PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy model/surgical guide kitA collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is 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
373139427
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
05404028001257SurgiCase PlannerSurgiCase Knee PlannerSurgiCase Knee Planner2026-05-28
05404028007006OrthoViewOrthoViewOrthoView2026-05-22
05404028001196Mimics Cardiac PlannerMimics Cardiac Planner TAVRMimics Cardiac Planner TAVR2026-05-15
05420060350856TruMatch CMF Titanium 3D Printed GuidesSD980.060SD980.0602026-04-29
05420060351631TruMatch CMF Titanium 3D Printed GuidesSD980.064SD980.0642026-04-29
05420060351648TruMatch CMF Titanium 3D Printed GuidesSD980.065SD980.0652026-04-29
05404028001202Mimics Automatic AlgorithmsMimics Automatic Algorithms CMF Orthognathic CT CBMimics Automatic Algorithms CMF Orthognathic CT CB2026-04-20
05404028001219Mimics Automatic Algorithms Mimics Automatic Algorithms CMF Reconstruction CT Mimics Automatic Algorithms CMF Reconstruction CT 2026-04-20
05404028001226Mimics Automatic Algorithms Mimics Automatic Algorithms Knee MRIMimics Automatic Algorithms Knee MRI2026-04-20
05404028001080Materialise Mimics Enlight CMFOrthognathic and Trauma PlannerOrthognathic and Trauma Planner2026-04-10
05404028001097Materialise Mimics Enlight CMFReconstruction PlannerReconstruction Planner2026-04-10
05404028001103Materialise Mimics Enlight CMFSplint DesignerSplint Designer2026-04-10
05404028001158Mimics FlowMimics FlowMimics Flow2026-03-23
05404028001172SurgiCase OnlineSurgiCase OnlineSurgiCase Online2026-03-23
05404028001189ProPlan CMF ProPlan CMF Online ProPlan CMF Online 2026-03-23
05404028000861Mimics Thoracic PlannerMimics Thoracic PlannerMimics Thoracic Planner2026-03-20
05420060360015BKS Total PSIKNM-OD01-00-01KNM-OD01-00-01 2022-09-21
05420060310027Zimmer Biomet Patient Specific InstrumentsKNM-ZB02-00-01KNM-ZB02-00-012018-08-11
05420060310034Zimmer Biomet Patient Specific InstrumentsKNM-ZB03-00-01KNM-ZB03-00-012018-08-11
05420060310041Zimmer Biomet Patient Specific InstrumentsKNM-ZB04-00-01KNM-ZB04-00-012018-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348215158828World Knee MC Poly Insert - Size 8 - 10mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158835World Knee MC Poly Insert - Size 8 - 11mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158842World Knee MC Poly Insert - Size 8 - 12mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158859World Knee MC Poly Insert - Size 8 - 13mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158866World Knee MC Poly Insert - Size 8 - 14mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158873World Knee MC Poly Insert - Size 8 - 15mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158880World Knee MC Poly Insert - Size 8 - 16mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158897World Knee MC Poly Insert - Size 8 - 17mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158903World Knee MC Poly Insert - Size 8 - 18mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158910World Knee MC Poly Insert - Size 8 - 10mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158927World Knee MC Poly Insert - Size 8 - 11mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158934World Knee MC Poly Insert - Size 8 - 12mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158941World Knee MC Poly Insert - Size 8 - 13mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158958World Knee MC Poly Insert - Size 8 - 14mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158965World Knee MC Poly Insert - Size 8 - 15mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158972World Knee MC Poly Insert - Size 8 - 16mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158989World Knee MC Poly Insert - Size 8 - 17mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215158996World Knee MC Poly Insert - Size 8 - 18mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160265World Knee MC Vit-E Poly Insert - Size 7 - 10mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160272World Knee MC Vit-E Poly Insert - Size 7 - 11mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160289World Knee MC Vit-E Poly Insert - Size 7 - 12mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160296World Knee MC Vit-E Poly Insert - Size 7 - 13mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160302World Knee MC Vit-E Poly Insert - Size 7 - 14mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160319World Knee MC Vit-E Poly Insert - Size 7 - 15mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160326World Knee MC Vit-E Poly Insert - Size 7 - 16mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160333World Knee MC Vit-E Poly Insert - Size 7 - 17mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160340World Knee MC Vit-E Poly Insert - Size 7 - 18mm, LeftSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160357World Knee MC Vit-E Poly Insert - Size 7 - 10mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160364World Knee MC Vit-E Poly Insert - Size 7 - 11mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09
09348215160371World Knee MC Vit-E Poly Insert - Size 7 - 12mm, RightSIGNATURE ORTHOPAEDICS PTY LTDMBH2026-06-09