DEVICE: iTotal Identity Posterior Stabilized Knee Replacement System (M572RPS0101700131)
Device Identifier (DI) Information
iTotal Identity Posterior Stabilized Knee Replacement System
RPS010170013
In Commercial Distribution
RPS0101700
Conformis, Inc.
RPS010170013
In Commercial Distribution
RPS0101700
Conformis, Inc.
ITOTAL IDENTITY PS TIBIAL INSERT, NO TRIAL, IPOLY, 17MM
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46585 | Tibial insert |
An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
OOG | Knee Arthroplasty Implantation System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K201023 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 17 Millimeter |
Device Record Status
0770acf3-3da5-4eb3-bc6e-71c12907fb44
March 07, 2022
2
July 02, 2020
March 07, 2022
2
July 02, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
781-345-0001
customer-service@conformis.com
customer-service@conformis.com