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

MBL · Predicate Candidate Screening

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

90 daysmedian FDA review time

390 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201157	Prime BIOFOAM® Multi-Hole Shells	Microport Orthopedics, Inc.	2021-08-24	481	0
K201701	R3 HA Coated Acetabular Shells	Smith & Nephew, Inc.	2020-10-06	106	0
K182535	R3 Anteverted Liners	Smith & Nephew, Inc.	2018-11-19	66	0
K161233	OXINIUM DH Fermoral Heads	Smith & Nephew, Inc.	2016-12-14	226	0
K122382	DYNASTY BIOFOAM SHELL	Wrightmedicaltechnologyinc	2012-10-22	77	0
K113848	R3 XLPE LINERS	Smith & Nephew, Inc.	2012-04-27	120	2
K102370	R3 XLPE ANTEVERTED LINERS	Smith & Nephew, Inc.	2011-01-19	152	0
K093363	COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS	Smith & Nephew, Inc.	2010-01-26	90	0
K092386	R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS	Smith & Nephew, Inc.	2009-11-03	90	0
K070756	SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM	Smith & Nephew, Inc.	2007-06-06	78	0
K061253	REFLECTION 3 ACETABULAR SYSTEM	Smith & Nephew, Inc.	2006-05-31	27	0
K960094	REFLECTION DUAL DIMENSION SHELL	Smith & Nephew Richards, Inc.	1996-03-27	76	1
K931107	LOGYK ACETABULAR COMPONENT SYSTEM	Arthronics, Inc.	1994-03-28	390	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