Atlas FDA

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

Crossroads Extremity Systems, LLC — Predicate Candidate Screening

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

78 daysmedian FDA review time
149 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incisionCrossroads Extremity Systems, LLC2023-03-301490
K220797FootHold SystemCrossroads Extremity Systems, LLC2022-04-15280
K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC2020-12-301410
K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC2019-04-12290
K181872MIS Bunion SystemCrossroads Extremity Systems, LLC2019-02-192220
K181866MotoCLIP/HiMAX Step Staple Implant SystemCrossroads Extremity Systems, LLC2018-08-09280
K181410MotoCLIP/HiMAX Implant SystemCrossroads Extremity Systems, LLC2018-06-29300
K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC2018-02-12700
K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC2016-05-031050
K160300MotoBand(TM) CP Implant SystemCrossroads Extremity Systems, LLC2016-04-22780
K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC2015-12-111190
K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC2015-09-23580
K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC2015-09-041140

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