Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

NPJ — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

84 daysmedian FDA review time

90 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K150307	RESTORIS Multicompartmental Knee System	Mako Surgical Corp.	2015-03-10	29	0
K133039	RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM	Mako Surgical Corporation	2013-12-10	75	0
K093513	IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM	Conformis, Inc.	2009-12-16	33	3
K093056	SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM	Smith & Nephew, Inc.	2009-12-15	76	0
K090763	RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM	Mako Surgical Corporation	2009-06-17	86	4
K070849	DEPUY GCK FEMORAL AND TIBIAL COMPONENTS	DePuy Orthopaedics, Inc.	2007-06-26	90	0
K061648	DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)	DePuy Orthopaedics, Inc.	2006-09-11	90	1
K061569	SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS	Smith & Nephew, Inc.	2006-07-06	30	0
K053488	CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM	Conformis, Inc.	2006-03-09	84	0
K052265	SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL	Smith & Nephew, Inc.	2005-12-27	130	42
K052917	STRYKER COMPARTMENTAL KNEE SYSTEM	Howmedica Osteonics Corp.	2005-12-27	71	7
K042896	SMITH & NEPHEW HYBRID KNEE FEMORAL	Smith & Nephew, Inc.	2005-01-12	84	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda