FDA.reportPublic FDA data

Zimmer Biomet Patient Specific Instruments

Primary DI
05420060310096
Brand
Zimmer Biomet Patient Specific Instruments
Company
Materialise NV
Model
KNM-ZB13-00-01
Catalog number
KNM-ZB13-00-01
Device description
MRI Zimmer Guide and Bone Model for Partial Knee Arthroplasty
Published
2018-08-11
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
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
K173970000
K202207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173970000Materialise PKA Guide SystemMaterialise NV2018-07-06HSX
K202207000Materialise PKA Guide SystemMaterialise NV2020-10-02HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05420060310096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420060310096054200603100965420060310096

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
E31442100200Signature42-10020042-1002002026-09-24
E31442100300Signature42-10030042-1003002026-09-24
E31442411410Signature42-41141042-4114102026-09-24
E31442422415Signature42-42241542-4224152026-09-24
E31442422450Signature42-42245042-4224502026-09-24
E31442422451Signature42-42245142-4224512026-09-24
E31442422452Signature42-42245242-4224522026-09-24
E31442422453Signature42-42245342-4224532026-09-24
E31442422455Signature42-42245542-4224552026-09-24
E31442422456Signature42-42245642-4224562026-09-24
E31442422457Signature42-42245742-4224572026-09-24
E31442422458Signature42-42245842-4224582026-09-24
E31442422460Signature42-42246042-4224602026-09-24
E31442422461Signature42-42246142-4224612026-09-24
E31442422462Signature42-42246242-4224622026-09-24
E31442422463Signature42-42246342-4224632026-09-24
E31442422465Signature42-42246542-4224652026-09-24
E31442422466Signature42-42246642-4224662026-09-24
E31442422467Signature42-42246742-4224672026-09-24
E31442422468Signature42-42246842-4224682026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536705Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536712Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536729Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536736Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536743Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536750Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536767Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536774Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536781Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536798Identity CR KARestor3d, Inc.OOG2026-09-25
00840097536804Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
00840097536811Identity CR KA 3DP PorousRestor3d, Inc.OOG2026-09-25
E31442411410SignatureMaterialise NVOOG2026-09-24
E31442422415SignatureMaterialise NVOOG2026-09-24
E31442422450SignatureMaterialise NVOOG2026-09-24
E31442422451SignatureMaterialise NVOOG2026-09-24
E31442422452SignatureMaterialise NVOOG2026-09-24
E31442422453SignatureMaterialise NVOOG2026-09-24
E31442422455SignatureMaterialise NVOOG2026-09-24
E31442422456SignatureMaterialise NVOOG2026-09-24
E31442422457SignatureMaterialise NVOOG2026-09-24
E31442422458SignatureMaterialise NVOOG2026-09-24
E31442422460SignatureMaterialise NVOOG2026-09-24
E31442422461SignatureMaterialise NVOOG2026-09-24
E31442422462SignatureMaterialise NVOOG2026-09-24
E31442422463SignatureMaterialise NVOOG2026-09-24
E31442422465SignatureMaterialise NVOOG2026-09-24
E31442422466SignatureMaterialise NVOOG2026-09-24
E31442422467SignatureMaterialise NVOOG2026-09-24
E31442422468SignatureMaterialise NVOOG2026-09-24