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

Paradigm Spine, LLC — Predicate Candidate Screening

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

94 daysmedian FDA review time

302 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153302	coflex-IF	Paradigm Spine, LLC	2016-09-08	300	0
K120491	DSS STABILIZATION SYSTEM-RIGID	Paradigm Spine, LLC	2012-05-09	82	0
K112595	COFLEX-F	Paradigm Spine, LLC	2012-02-13	159	0
K113625	DSS STABILIZATION SYSTEM	Paradigm Spine, LLC	2012-01-10	33	0
K093438	PARADIGM INTERSPINOUS FUSION PLATE	Paradigm Spine, LLC	2010-10-06	336	1
K101083	DSS STABILIZATION SYSTEM	Paradigm Spine, LLC	2010-07-02	74	0
K091944	MODIFICATION TO: DSS STABILIZATION SYSTEM	Paradigm Spine, LLC	2009-08-03	34	0
K090099	DSS STABILIZATION SYSTEM	Paradigm Spine, LLC	2009-06-19	155	0
K090408	MODIFICATION TO: DSS STABILIZATION SYSTEM	Paradigm Spine, LLC	2009-03-20	30	0
K080241	DDS STABILIZATION SYSTEM	Paradigm Spine, LLC	2008-11-28	302	0
K072969	DSS	Paradigm Spine, LLC	2008-01-24	94	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