iTotal® PS RPS1011112

GUDID M572RPS1011112021

iTotal® Posterior Stabilized (PS) Knee Tibial Kit

Conformis, Inc.

Total knee prosthesis implantation guide-instrument kit

• Primary Device ID: M572RPS1011112021
• NIH Device Record Key: 7c2cf8f2-08be-4bed-be05-21d46e7902bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal® PS
• Version Model Number: RPS101111202
• Catalog Number: RPS1011112
• 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: true
• 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: +1-781-345-9001
• Email: customer-service@conformis.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572RPS1011112021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160025

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-10-24

On-Brand Devices [iTotal® PS]

• M572RPS1011113021: iTotal® Posterior Stabilized (PS) Knee Tibial Kit
• M572RPS1011112021: iTotal® Posterior Stabilized (PS) Knee Tibial Kit
• M572TPS1111111021: iTotal® Posterior Stabilized (PS) Knee Replacement System
• M572RPS0102000021: iTotal® Posterior Stabilized (PS) Knee Insert Kit
• M572RPS0101700021: iTotal® Posterior Stabilized (PS) Knee Insert Kit