NPJ · Class II · 21 CFR 888.3560

FDA Product Code NPJ: Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer

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.

Leading manufacturers include Smith & Nephew, Inc., Conformis, Inc. and DePuy Orthopaedics, Inc..

12
Total
12
Cleared
73d
Avg days
2005
Since

FDA 510(k) Cleared Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer Devices (Product Code NPJ)

12 devices
1–12 of 12
Cleared Mar 10, 2015
RESTORIS Multicompartmental Knee System
K150307
Mako Surgical Corp.
Orthopedic · 29d
Cleared Dec 16, 2009
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
K093513
Conformis, Inc.
Orthopedic · 33d
Cleared Dec 15, 2009
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
K093056
Smith & Nephew, Inc.
Orthopedic · 76d
Cleared Jun 26, 2007
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
K070849
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Sep 11, 2006
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
K061648
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jul 06, 2006
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
K061569
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 09, 2006
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM
K053488
Conformis, Inc.
Orthopedic · 84d
Cleared Dec 27, 2005
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
K052265
Smith & Nephew, Inc.
Orthopedic · 130d
Cleared Dec 27, 2005
STRYKER COMPARTMENTAL KNEE SYSTEM
K052917
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Jan 12, 2005
SMITH & NEPHEW HYBRID KNEE FEMORAL
K042896
Smith & Nephew, Inc.
Orthopedic · 84d

About Product Code NPJ - Regulatory Context