Atlas FDA

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

Extremity Medical, LLC — Predicate Candidate Screening

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

68 daysmedian FDA review time
226 days90th percentile
28clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250536MetaFore Small Screw SystemExtremity Medical, LLC2025-10-082260
K251128Extremity Medical External Fixation SystemExtremity Medical, LLC2025-05-07260
K241563Extremity Medical External Fixation SystemExtremity Medical, LLC2025-02-212660
K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC2021-08-20290
K211261Axis Charcot Fixation SystemExtremity Medical, LLC2021-05-28320
K201556Intraosseous Fixation SystemExtremity Medical, LLC2020-07-08280
K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC2020-03-042680
K192592Axis Plating SystemExtremity Medical, LLC2019-11-21620
K181067AlignX Ankle Fusion SystemExtremity Medical, LLC2018-05-23300
K180808Omni Foot Plating SystemExtremity Medical, LLC2018-05-22550
K172260Omni Foot Plating SystemExtremity Medical, LLC2017-11-061020
K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC2017-07-13990
K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC2016-03-25580
K152710HammerFiX DeviceExtremity Medical, LLC2015-10-15240
K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC2015-03-04230
K150166Extremity Medical Suture AnchorExtremity Medical, LLC2015-02-23280
K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC2015-02-04680
K133636EXTREMITY MEDICAL HAMMERTOE DEVICEExtremity Medical, LLC2014-03-281220
K130120EXTREMITY MEDICAL IP FUSION SYSTEMExtremity Medical, LLC2013-04-11840
K121349IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND Extremity Medical, LLC2012-07-18750
K121417XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEMExtremity Medical, LLC2012-07-18680
K101700IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEMExtremity Medical, LLC2010-10-121172
K093770EXTREMITY MEDICAL SCREW SYSTEMExtremity Medical, LLC2010-04-281410
K092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLC2009-12-151180
K091577EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLAExtremity Medical, LLC2009-07-24520
K082934EXTREMITY MEDICAL MIDFOOT SCREW SYSTEMExtremity Medical, LLC2009-04-232040
K083151EXTREMITY MEDICAL SUTURE ANCHORExtremity Medical, LLC2009-01-22900
K081934EXTREMITY MEDICAL COMPRESSION SCREWExtremity Medical, LLC2008-08-29530

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