Atlas FDA

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

Intelligent Implant Systems, LLC — Predicate Candidate Screening

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

111 daysmedian FDA review time
119 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K173935Mediant Anterior Cervical Plating SystemIntelligent Implant Systems, LLC2018-04-161110
K163056Revolution™ Spinal Fixation SystemIntelligent Implant Systems, LLC2017-02-241150
K160216Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC2016-04-22840
K142939Revolution Spinal Fixation SystemIntelligent Implant Systems, LLC2015-01-13960
K132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLC2013-10-25390
K121682ACTIVE SCREW BONE SCREWIntelligent Implant Systems, LLC2012-10-041190

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