ITotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Conformis, Inc.

The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal® Identity™ Cruciate Retaining (cr) Knee Replacement System (krs).

Pre-market Notification Details

• Device ID: K210809
• 510k Number: K210809
• Device Name: ITotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: Conformis, Inc. 600 Technology Park Drive, Fourth Floor Billerica, MA 01821
• Contact: Mary Kruitwagen
• Correspondent: Mary Kruitwagen; Conformis, Inc. 600 Technology Park Drive, Fourth Floor Billerica, MA 01821
• Product Code: JWH
• Subsequent Product Code: OIY
• Subsequent Product Code: OOG
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-17
• Decision Date: 2021-05-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M572RCR013170M111	K210809	000
M572RCR013080C111	K210809	000
M572RCR013090D111	K210809	000
M572RCR013100E111	K210809	000
M572RCR013110F111	K210809	000
M572RCR013120G111	K210809	000
M572RCR013130H111	K210809	000
M572RCR013140J111	K210809	000
M572RCR013150K111	K210809	000
M572RCR013160L111	K210809	000
M572RCR023090D011	K210809	000
M572RCR023100E011	K210809	000
M572RCR023110F011	K210809	000
M572RCR023120G011	K210809	000
M572RCR023130H011	K210809	000
M572RCR023140J011	K210809	000
M572RCR023150K011	K210809	000
M572RCR023160L011	K210809	000
M572RCR013070B111	K210809	000
M572RCR013060A111	K210809	000
M572RCR023200R111	K210809	000
M572RCR013180N111	K210809	000
M572RCR013190P111	K210809	000
M572RCR013200R111	K210809	000
M572RCR023060A111	K210809	000
M572RCR023070B111	K210809	000
M572RCR023080C111	K210809	000
M572RCR023090D111	K210809	000
M572RCR023100E111	K210809	000
M572RCR023110F111	K210809	000
M572RCR023120G111	K210809	000
M572RCR023130H111	K210809	000
M572RCR023140J111	K210809	000
M572RCR023150K111	K210809	000
M572RCR023160L111	K210809	000
M572RCR023170M111	K210809	000
M572RCR023180N111	K210809	000
M572RCR023190P111	K210809	000
M572RCR023170M011	K210809	000
M572RCR023180N011	K210809	000
M572TCR013060A011	K210809	000
M572TCR013070B011	K210809	000
M572TCR013080C011	K210809	000
M572TCR013090D011	K210809	000
M572TCR013100E011	K210809	000
M572TCR013110F011	K210809	000
M572TCR013120G011	K210809	000
M572TCR013130H011	K210809	000
M572TCR013140J011	K210809	000
M572TCR023060A011	K210809	000
M572TCR023070B011	K210809	000
M572TCR023080C011	K210809	000
M572TCR023090D011	K210809	000
M572TCR023100E011	K210809	000
M572TCR023110F011	K210809	000
M572TCR023120G011	K210809	000
M572TCR023130H011	K210809	000
M572RCR023080C011	K210809	000
M572RCR023070B011	K210809	000
M572RCR023060A011	K210809	000
M572RCR023190P011	K210809	000
M572RCR023200R011	K210809	000
M572RCR013060A011	K210809	000
M572RCR013070B011	K210809	000
M572RCR013080C011	K210809	000
M572RCR013090D011	K210809	000
M572RCR013100E011	K210809	000
M572RCR013110F011	K210809	000
M572RCR013120G011	K210809	000
M572RCR013130H011	K210809	000
M572RCR013140J011	K210809	000
M572RCR013150K011	K210809	000
M572RCR013160L011	K210809	000
M572RCR013170M011	K210809	000
M572RCR013180N011	K210809	000
M572RCR013190P011	K210809	000
M572RCR013200R011	K210809	000
M572TCR023140J011	K210809	000