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

Ellipse Technologies, Incorporated — Predicate Candidate Screening

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

58 daysmedian FDA review time

227 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K160267	PRECICE Trauma Nail System	Ellipse Technologies, Incorporated	2016-03-31	58	0
K151594	Ellipse Supplemental Instrument Trays	Ellipse Technologies, Incorporated	2016-01-25	227	0
K152370	PRECICE Trauma Nail System	Ellipse Technologies, Incorporated	2015-12-22	123	0
K151131	PRECICE Intramedullary Limb Lengthening System	Ellipse Technologies, Incorporated	2015-06-19	52	2
K150885	MAGEC 2 Spinal Bracing and Distraction System	Ellipse Technologies, Incorporated	2015-05-29	57	0
K150656	PRECICE Intramedullary Limb Lengthening System	Ellipse Technologies, Incorporated	2015-04-23	41	0
K142599	PRECISE Trauma Nail System	Ellipse Technologies, Incorporated	2015-01-16	123	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