FDA.reportPublic FDA data

Zimmer Patient Specific Instruments

Primary DI
E31400597000004
Brand
Zimmer Patient Specific Instruments
Company
Materialise NV
Model
00-5970-000-04
Catalog number
00-5970-000-04
Device description
Unicompartmental High Flex Knee (Femur and Tibia)
Published
2016-09-24
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
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112301000ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNERMaterialise NV2012-01-06HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E31400597000004PrimaryHIBCC0

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
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
05420060380747TRUMATCHSD980.028SD980.0282025-02-28
05420060363191TruMatch Personalised Solutions Shoulder System2255010032255010032022-03-11
E314KNMLM010101Lima PSIKNM-LM01-01-01KNM-LM01-01-012016-12-01
E314KNMLM0101010Lima PSIKNM-LM01-01-01KNM-LM01-01-012017-07-21
E314KNMLM010201Lima PSIKNM-LM01-02-01KNM-LM01-02-012016-12-01
E314KNMLM0102010Lima PSIKNM-LM01-02-01KNM-LM01-02-012017-07-21
E314KNMLM020001Lima PSIKNM-LM02-00-01KNM-LM02-00-012016-12-01
E314KNMLM0200010Lima PSIKNM-LM02-00-01KNM-LM02-00-012017-07-21
E314SHCLM010101Lima PSISHC-LM01-01-01SHC-LM01-01-012016-12-01
E314SHCLM0101010Lima PSISHC-LM01-01-01SHC-LM01-01-012017-07-21
E314SHCLM020101Lima PSISHC-LM02-01-01SHC-LM02-01-012016-12-01
E314SHCLM0201010Lima PSISHC-LM02-01-01SHC-LM02-01-012017-07-21
05420060381041TruMatchSD980.104SD980.1042020-03-16
05420060351013ProPlan CMFSD900.101SD900.1012016-09-13
05420060351020ProPlan CMFSD900.102SD900.1022016-09-13
05420060351044ProPlan CMFSD900.104SD900.1042016-09-13
05420060351051ProPlan CMFSD900.105SD900.1052016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536552iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536569iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536576iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536583iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
00840097536590iTotal Identity CR 3DP PorousRestor3d, Inc.OOG2026-07-31
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
05404028001257SurgiCase PlannerMaterialise NVOOG2026-05-28
05404028000922SurgiCase PlannerMaterialise NVOOG2025-05-14
05404028000922SurgiCase PlannerMaterialise NVHSX2025-05-14
00822409130153N/AOrtho Development CorporationHSX2025-03-17
00822409130160N/AOrtho Development CorporationHSX2025-03-17
00822409130177N/AOrtho Development CorporationHSX2025-03-17
00822409130184N/AOrtho Development CorporationHSX2025-03-17
00822409130191N/AOrtho Development CorporationHSX2025-03-17
00822409130207N/AOrtho Development CorporationHSX2025-03-17
00822409130214N/AOrtho Development CorporationHSX2025-03-17
00822409130221N/AOrtho Development CorporationHSX2025-03-17
00822409130238N/AOrtho Development CorporationHSX2025-03-17
00822409130245N/AOrtho Development CorporationHSX2025-03-17
00822409130252N/AOrtho Development CorporationHSX2025-03-17
00822409130269N/AOrtho Development CorporationHSX2025-03-17
00885556779989VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
00885556779989VISIONAIRESmith & Nephew, Inc.OOG2021-09-22
00885556780039VISIONAIRESmith & Nephew, Inc.OOG2021-09-22
00885556780039VISIONAIRESmith & Nephew, Inc.HSX2021-09-22
E314SURGICASEKNEEPLAN0SurgiCase PlannerMaterialise NVHSX2018-10-17
E314SURGICASEKNEEPLAN0SurgiCase PlannerMaterialise NVOOG2018-10-17
E314KNMCO0101010BespokeMATERIALISE USA, L.L.C.OOG2017-07-21
E314KNMCO0102010BespokeMATERIALISE USA, L.L.C.OOG2017-07-21
E314KNMCO0200010BespokeMATERIALISE USA, L.L.C.OOG2017-07-21