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

Smith & Nephew — Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

142 daysmedian FDA review time

254 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K241666	EVOS Pelvic and Acetabular System	Smith & Nephew	2025-02-19	254
K240487	EVOS Patella Plates	Smith & Nephew	2024-09-03	196
K233730	Footprint Mini PK, 3.5mm Suture Anchor	Smith & Nephew	2024-01-17	57
K232457	Q-FIX ULTRA All-Suture Anchor	Smith & Nephew	2023-09-08	25
K223762	Smith & Nephew ACCORD™ Cable System	Smith & Nephew	2023-05-30	166
K221929	Smith+Nephew INTELLIO Tablet	Smith+Nephew	2022-09-06	67
K203566	Tablet Application	Smith & Nephew	2021-05-13	157
K201253	Modular Rail System, TAYLOR SPATIAL FRAME External Fixator,	Smith & Nephew	2020-12-08	211
K201349	Smith+Nephew Arthroscopes	Smith & Nephew	2020-07-20	60
K201198	S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparosc	Smith & Nephew	2020-07-17	74
K192876	INTELLIO Tablet Application	Smith & Nephew	2020-02-27	142
K190367	Smith & Nephew Tablet Application	Smith & Nephew	2019-05-21	95
K172785	CONQUEST FN	Smith & Nephew	2017-12-22	98
K163653	NOVOS-NAIL Limb Lengthening System (LLS)	Smith & Nephew	2017-10-13	294
K153606	LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LE	Smith & Nephew	2016-06-02	168
K152686	CONQUEST FN	Smith & Nephew	2016-03-17	181
K151118	Smith and Nephew Legion Hinge Knee System	Smith & Nephew	2015-07-28	92

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