iTotal PS RPS-020-2100

GUDID M572RPS0202100121

ITOTAL PS IPOLY XE - 21MM INSERT - LEFT or right NO TRIAL

Conformis, Inc.

Tibial insert

• Primary Device ID: M572RPS0202100121
• NIH Device Record Key: 34fc95f2-e1df-477d-b20c-ce7c5538f1b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal PS
• Version Model Number: RPS-020-210012
• Catalog Number: RPS-020-2100
• Company DUNS: 808821883
• Company Name: Conformis, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572RPS0202100121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140833

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

On-Brand Devices [iTotal PS]

• M572TPS1111111011: ITOTAL PS IPOLY IMPLANT KIT LEFT or right
• M572RPS0202000121: ITOTAL PS IPOLY XE - 20MM INSERT - RIGHT or left NO TRIAL
• M572RPS0201900121: ITOTAL PS IPOLY XE - 19MM INSERT - LEFT or right NO TRIAL
• M572RPS0201800121: ITOTAL PS IPOLY XE - 18MM INSERT - LEFT or right NO TRIAL
• M572RPS0201700121: ITOTAL PS IPOLY XE - 17MM INSERT - LEFT or right NO TRIAL
• M572RPS0201600121: ITOTAL PS IPOLY XE - 16MM INSERT - LEFT or right NO TRIAL
• M572RPS0201500121: ITOTAL PS IPOLY XE - 15MM INSERT - LEFT or right NO TRIAL
• M572RPS0201400121: ITOTAL PS IPOLY XE - 14MM INSERT - LEFT or right NO TRIAL
• M572RPS0201300121: ITOTAL PS IPOLY XE - 13MM INSERT - LEFT or right NO TRIAL
• M572RPS0201200121: iTOTAL PS IPOLY XE - 12MM INSERT - LEFT or right NO TRIAL
• M572RPS0201100121: ITOTAL PS / IPOLY XE - 11MM INSERT - LEFT or right NO TRIAL
• M572RPS0102000121: ITOTAL PS - IPOLY - 20MM INSERT - LEFT or right NO TRIAL
• M572RPS0102000111: ITOTAL PS - IPOLY - 20MM INSERT – LEFT or right - NO TRIAL
• M572RPS0101900121: ITOTAL PS - IPOLY - 19MM INSERT – LEFT or right - NO TRIAL
• M572RPS0101900111: ITOTAL PS - IPOLY - 19MM INSERT - LEFT or right- NO TRIAL
• M572RPS0101500121: ITOTAL PS - IPOLY - 15MM INSERT - LEFT - NO TRIAL or right
• M572RPS0101500111: ITOTAL PS - IPOLY - 15MM INSERT - LEFT or right - NO TRIAL
• M572RPS0202200121: ITOTAL PS IPOLY XE - 22MM INSERT - LEFT or right NO TRIAL
• M572RPS0202100121: ITOTAL PS IPOLY XE - 21MM INSERT - LEFT or right NO TRIAL
• M572RPS0201000121: ITOTAL PS IPOLY XE - 10MM INSERT - LEFT or right NO TRIAL
• M572RPS0200800121: ITOTAL PS/ IPOLY XE - 8MM INSERT - RIGHT or left NO TRIAL
• M572RPS0200700121: ITOTAL PS IPOLY XE - 7MM INSERT - RIGHT or left NO TRIAL
• M572RPS0200600121: ITOTAL PS IPOLY XE - 6MM INSERT - LEFT or right NO TRIAL
• M572RPS0102200021: ITOTAL PS IPOLY 22MM INSERT LEFT or right
• M572RPS0101800011: ITOTAL PS - IPOLY - 18MM INSERT - LEFT or right
• M572RPS0101600011: ITOTAL PS - IPOLY - 16MM INSERT - LEFT or right
• M572RPS0200900121: ITOTAL PS IPOLY XE - 9MM INSERT - RIGHT NO TRIAL