510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NPJClass II

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

21 CFR 888.3560 / Orthopedic
FDA source (opens on fda.gov)

NPJ is the FDA product code for Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a class II device type, regulated under 21 CFR 888.3560. FDA's definition for this code 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 device is intended to be used with bone cement". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
NPJ
Device name
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
FDA definition
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 device is intended to be used with bone cement.
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
9

Clearances, product code NPJ

By decision year
12 clearances under product code NPJ with a decision year between 2005 and 2015, 2005 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NPJ by decision year
YearClearances
20053
20063
20071
20093
20131
20151

Applicants with the most clearances

Product code NPJ
Applicants holding the most 510(k) clearances under product code NPJ
ApplicantClearances
Smith & Nephew, Inc.4
Mako Surgical Corp.3
ConforMIS, Inc.2
Depuy Orthopaedics Inc.2
Howmedica Osteonics Corp1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order