510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053488Substantially Equivalent

Conformis Bicompartmental Knee Repair System

ConforMIS, Inc., Foster City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053488 is the FDA 510(k) clearance record for CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM, a class II device, cleared for Conformis, Inc. on under FDA product code NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA's definition for product code NPJ reads: "The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The...". FDA records list 60 510(k) clearances for Conformis, Inc., from to . As of , FDA records show no recalls naming K053488.

Clearance record

Decision date
Received
(84 days to decision)
Product code
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Conformis, Inc. 323 Vintage Park Dr., Foster City CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPJ

Trailing 12 months

FDA records hold no clearances under product code NPJ in the trailing twelve months.

FDA records show no clearances under product code NPJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NPJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260