FDA.reportPublic FDA data

Zimmer Biomet Patient Specific Instruments

Primary DI
05420060310089
Brand
Zimmer Biomet Patient Specific Instruments
Company
Materialise NV
Model
KNM-ZB12-00-01
Catalog number
KNM-ZB12-00-01
Device description
ZB MRI PKA Guide kit
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
05420060310089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05420060310089054200603100895420060310089

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
05404028001394SurgiCase Shoulder PlannerSurgiCase Shoulder PlannerSurgiCase Shoulder Planner2026-11-03
05404028001370Mimics Cardiac PlannerMimics Cardiac Planner TAVRMimics Cardiac Planner TAVR2026-10-30
05420060351235TRUMATCHSD980.041SD980.0412026-10-22
05420060351242TRUMATCHSD980.042SD980.0422026-10-22
05420060351259TRUMATCHSD980.043SD980.0432026-10-22
05420060351266TRUMATCHSD980.044SD980.0442026-10-22
05420060351273TRUMATCHSD980.045SD980.0452026-10-22
05420060351280TRUMATCHSD980.046SD980.0462026-10-22
05420060351297TRUMATCHSD980.047SD980.0472026-10-22
05420060351303TRUMATCHSD980.048SD980.0482026-10-22
05420060351310TRUMATCHSD980.049SD980.0492026-10-22
05420060351327TRUMATCHSD980.050SD980.0502026-10-22
05420060351334TRUMATCHSD980.051SD980.0512026-10-22
05420060351341TRUMATCHSD980.052SD980.0522026-10-22
05420060351358TRUMATCHSD980.053SD980.0532026-10-22
05420060351365TRUMATCHSD980.054SD980.0542026-10-22
05420060351372TRUMATCHSD980.055SD980.0552026-10-22
05420060351389TRUMATCHSD980.056SD980.0562026-10-22
05420060351396TRUMATCHSD980.057SD980.0572026-10-22
05420060351402TRUMATCHSD980.058SD980.0582026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20
TKRL00020IBI0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-10-20