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

Smith & Nephew, Inc., Orthopaedic Div. · Predicate Candidate Screening

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

67 daysmedian FDA review time

175 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K991538	OPERA CUPFLANGED ACETABULAR COMPONENTS	Smith & Nephew, Inc., Orthopaedic Div.	1999-06-03	31
K970635	TITANIUM SPINAL ROD SYSTEM	Smith & Nephew, Inc., Orthopaedic Div.	1997-08-14	175
K971414	ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEAD	Smith & Nephew, Inc., Orthopaedic Div.	1997-07-16	91
K970748	TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM	Smith & Nephew, Inc., Orthopaedic Div.	1997-05-09	67
K970751	HEIDELBERG EXTERNAL FIXATOR	Smith & Nephew, Inc., Orthopaedic Div.	1997-04-16	44
K970713	COMPASS UNIVERSAL HINGE	Smith & Nephew, Inc., Orthopaedic Div.	1997-04-03	35
K970351	GLOBAL TAPER SPECTRON HIP STEMS	Smith & Nephew, Inc., Orthopaedic Div.	1997-02-28	29
K970337	HA GLOBAL TAPER (GT) TAPERED HIP STEM	Smith & Nephew, Inc., Orthopaedic Div.	1997-02-28	30
K963255	PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PRO	Smith & Nephew, Inc., Orthopaedic Div.	1997-01-02	136
K962784	ULTIUM SPINAL PLATING SYSTEM	Smith & Nephew, Inc., Orthopaedic Div.	1996-10-02	77

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