510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K094050Substantially Equivalent

Itotal Cr Knee Replacement System

ConforMIS, Inc., Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K094050 is the FDA 510(k) clearance record for ITOTAL CR KNEE REPLACEMENT SYSTEM, a class II device, cleared for Conformis, Inc. on under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA records list 60 510(k) clearances for Conformis, Inc., from to . As of , FDA records show no recalls naming K094050.

Clearance record

Decision date
Received
(259 days to decision)
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Conformis, Inc. 2 Fourth Ave., Burlington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JWH

Trailing 12 months
13 clearances under product code JWH in the twelve months to November 2026, September 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code JWH, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20261
September 20266
October 20260
November 20260