NPJ

12 FDA 510(k) clearances · Product code

84 daysmedian time to decision

90 days90th percentile

12clearances measured

FDA profile

Official device name: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3560
Medical specialty: Orthopedic
Flags: Implant
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.
Adverse events (MAUDE): 2021: 51 · 2022: 32 · 2023: 52 · 2024: 44 · 2025: 49 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Record	Firm	Date
RESTORIS Multicompartmental Knee System (K150307)	Mako Surgical Corp.	2015-03-10
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (K133039)	Mako Surgical Corporation	2013-12-10
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K093513)	Conformis, Inc.	2009-12-16
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (K093056)	Smith & Nephew, Inc.	2009-12-15
RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (K090763)	Mako Surgical Corporation	2009-06-17
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (K070849)	DePuy Orthopaedics, Inc.	2007-06-26
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (K061648)	DePuy Orthopaedics, Inc.	2006-09-11
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (K061569)	Smith & Nephew, Inc.	2006-07-06
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (K053488)	Conformis, Inc.	2006-03-09
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL (K052265)	Smith & Nephew, Inc.	2005-12-27
STRYKER COMPARTMENTAL KNEE SYSTEM (K052917)	Howmedica Osteonics Corp.	2005-12-27
SMITH & NEPHEW HYBRID KNEE FEMORAL (K042896)	Smith & Nephew, Inc.	2005-01-12

Every clearance here is in the API, with alerts when new ones post.