Atlas FDA

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

Ellipse Technologies, Inc. — Predicate Candidate Screening

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

103 daysmedian FDA review time
353 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2016-04-04590
K141278MAGEC SPINAL BRACING AND DISTRACTION SYSTEMEllipse Technologies, Inc.2015-03-243120
K141739RESIDUAL LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.2014-10-071022
K140613MAGEC SPINAL BRACING AND DISTRACTION SYSTEMEllipse Technologies, Inc.2014-09-181920
K141447PRECICE TRAUMA NAIL SYSTEMEllipse Technologies, Inc.2014-06-30280
K141023PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.2014-05-20290
K140178ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEMEllipse Technologies, Inc.2014-02-27340
K131490ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.2014-01-232450
K133289PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.2013-12-09450
K131677PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.2013-10-111230
K113219ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.2012-10-193530
K113695ELLIPSE PRECICE TRAUMA NAIL SYSTEMEllipse Technologies, Inc.2012-03-281032
K101997ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEMEllipse Technologies, Inc.2011-07-123622

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