FDA.reportPublic FDA data

X-PSI Knee

Primary DI
00887868557590
Brand
X-PSI Knee
Company
Orthosoft Inc
Model
803.308
Catalog number
803.308
Published
2022-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
LLZSystem, Image Processing, Radiological
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
LLZSystem, Image Processing, RadiologicalRadiology2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171269000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171269000X-PSI Knee SystemOrthosoft Inc (D/B/A Zimmer Cas)2017-12-28JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868557590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868557590008878685575908878685575900887868557590

Contacts#

Phone, Email table
PhoneEmail
+1(866)336-7846zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
205670032
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868552113Signature ONE Software Package302.40182026-10-27
00887868578922ROSA® Knee20-8020-130-012026-10-27
00887868578939ROSA Partial Knee Software20-8020-150-012026-10-27
00887868581090ROSA® Robotics20-8020-028-002026-10-27
00887868581106ROSA® Robotics20-8020-029-002026-10-27
00889024305533iASSIST20-8011-070-042026-10-27
00889024305557iASSIST20-8011-070-082026-10-27
00889024671270ROSA® Hip20-8060-400-012026-10-27
00887868573040Sesamoid® System20-8000-000-012026-10-26
00887868573057Sesamoid® System20-8000-000-022026-10-26
00887868579608ROSA® Robotics20-8000-010-062026-10-26
00887868579615ROSA® Robotics20-8000-010-172026-10-26
00887868579622ROSA® Robotics20-8000-010-332026-10-26
00887868579639ROSA® Robotics20-8000-010-352026-10-26
00887868579646ROSA® Robotics20-8000-010-362026-10-26
00889024705999Navitracker20-8000-070-052026-10-26
00889024707047Signature ONE Software Package302.4018302.40182026-07-10
00887868552120ROSA®20-8020-158-0020-8020-158-002023-04-10
00887868558146ROSA® Shoulder20-8087-302-00208087302002024-03-06
00887868580963ROSA® Shoulder20-8087-506-00208087506002024-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017265438EXULT Tibial InsertCorentec Co., LtdJWH2026-11-05
08800017265445EXULT Tibial InsertCorentec Co., LtdJWH2026-11-05
75401622522156Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-11-05
00192629475007EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475144EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475151EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475168EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475175EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475182EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475199EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475205EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475212EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475229EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475236EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475243EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475250EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03
00192629475267EVOLUTIONMicroport Orthopedics Inc.JWH2026-11-03