FDA.reportPublic FDA data

Zimmer Patient Specific Instrument

Primary DI
00889024211629
Brand
Zimmer Patient Specific Instrument
Company
Orthosoft Inc
Model
803.3020
Catalog number
803.3020
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K131409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131409000CAS PSI KNEE SYSTEMOrthosoft, Inc.2013-09-13JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024211629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024211629008890242116298890242116290889024211629

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800)-348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
205670032
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868558467iASSIST® Knee System302.4021302.40212022-09-21
00887868558474iASSIST® Knee System20-8011-900-1320-8011-900-132022-09-21
00889024211605NA302.4002302.40022016-09-14
00889024211636iASSIST302.4001302.40012016-09-14
00889024305083Sesamoid20-8000-070-3520-8000-070-352016-09-12
00889024305090Sesamoid20-8000-070-3620-8000-070-362016-09-12
00889024305106Sesamoid20-8000-070-3720-8000-070-372016-09-12
00889024305113Sesamoid20-8000-070-3820-8000-070-382016-09-12
00889024305120Sesamoid20-8000-070-3920-8000-070-392016-09-12
00889024305205Sesamoid20-8000-070-6420-8000-070-642016-09-12
00889024478954Sesamoid Plasty V2 Stand20-8000-070-8020-8000-070-802016-12-21
00889024478961Camera Kit20-8000-070-9920-8000-070-992016-12-21
00889024478978Sesamoid Plasty V2 Computer Kit20-8000-070-7720-8000-070-772016-12-21
00889024485518AC power cord North America20-8000-070-7120-8000-070-712016-12-21
00889024488502Sesamoid Plasty V2 HDMI Cable 30'20-8000-071-242017-04-10
00889024492752NA20-8000-070-212017-09-12
00889024492769NA20-8000-070-462017-09-12
00889024511026ROSA® Recon Platform20-8020-100-0120-8020-100-012019-03-06
00889024511170ROSA® Recon20-8020-110-0120-8020-110-012019-03-06
00889024511323ROSA® KNEE OPTICAL UNIT20-8020-120-0120-8020-120-012019-03-06

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