Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

OSH — Predicate Candidate Screening

19 FDA 510(k) clearances under this product code; the 50 most recent screened below.

80 daysmedian FDA review time
133 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K153446OLYMPIC Posterior Spinal Fixation SystemAstura Medical2016-04-081330
K140276CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek2014-03-13380
K132574PASS LP SPINAL SYSTEMMedicrea International2013-11-08840
K132303IMPLANET SPINE SYSTEMImplanet, S.A.2013-10-10780
K132575PASS LP SPINAL SYSTEMMedicrea International2013-10-03480
K131802EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEMDepuy Spine, A Johnson & Johnson Company2013-09-12850
K131615POLARIS SPINAL SYSTEMBiomet Spine (Aka Ebi, LLC)2013-09-04930
K131784RANGE SPINAL SYSTEMK2m, Inc.2013-08-30730
K131321CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek USA2013-06-05280
K124058CREO STABILIZATION SYSTEMGlobus Medical, Inc.2013-05-131330
K131030RANGE SPINAL SYSTEMK2m, Inc.2013-05-09270
K130655RESPONSE SPINE SYSTEMOrthoPediatrics Corp.2013-05-08570
K122877RANGE SPINAL SYSTEM, SMALL STATUREK2m, Inc.2013-05-082310
K130330RANGE SPINAL SYSTEMK2m, Inc.2013-05-02800
K123412RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTSK2m, Inc.2013-02-13990
K123138PASS LP SPINAL SYSTEMMedicrea International2013-02-051230
K121630RANGE SPINAL SYSTEMK2m, Inc.2012-09-11990
K121250OP SPINE SYSTEMOrthoPediatrics Corp.2012-06-19550
K120291OP SPINE SYSTEMOrthoPediatrics Corp.2012-04-16760

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