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 IDK210809
510k NumberK210809
Device Name:ITotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Conformis, Inc. 600 Technology Park Drive, Fourth Floor Billerica,  MA  01821
ContactMary Kruitwagen
CorrespondentMary Kruitwagen
Conformis, Inc. 600 Technology Park Drive, Fourth Floor Billerica,  MA  01821
Product CodeJWH  
Subsequent Product CodeOIY
Subsequent Product CodeOOG
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-17
Decision Date2021-05-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

Trademark Results [ITotal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ITOTAL
ITOTAL
77519937 4006512 Live/Registered
ConforMIS, Inc.
2008-07-11
ITOTAL
ITOTAL
77200561 not registered Dead/Abandoned
ConforMIS, Inc.
2007-06-07
ITOTAL
ITOTAL
76133213 2498210 Dead/Cancelled
ConnecTotal Staffing, Inc.
2000-09-22

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