Atlas FDA

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

KXE — Predicate Candidate Screening

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

85 daysmedian FDA review time
225 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190599Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLC2019-05-03560
K142569Aptis Medical Distal Radio Ulnar Joint ImplantAptis Medical, LLC2015-04-032030
K112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTAscension Orthopedic2012-04-092240
K081025ISOELASTICURemi Sciences, Inc.2008-11-212250
K082839DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC2008-10-24280
K061146SBI ULNAR HEAD IMPLANTSmall Bone Innovations, Inc.2006-07-19852
K053119DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC2005-12-07300
K052137ASCENSION MUHAscension Orthopedics, Inc.2005-11-03900
K040497DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC2005-01-263350
K042902HERBERT ULNAR HEAD PROSTHESIS SYSTEMStuckenbrock Medizintechnik GmbH2004-12-27680
K033930KAPP CUSTOM ULNAR HEAD WRIST IMPLANTKapp Surgical Instrument, Inc.2004-07-282230
K020274WMT MODULAR ULNAR HEAD IMPLANTWrightmedicaltechnologyinc2002-02-22250
K010786ULNAR HEAD IMPLANTAvanta Orthopaedics, Inc.2001-04-11271
K982268ULNAR HEAD IMPLANTAvanta Orthopaedics, Inc.1998-12-041580
K812053SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)Dow Corning Corp. Healthcare Industries Materials1981-08-18280
K790125ULNAR HEAD PROTHESISCutter Laboratories, Inc.1979-02-08160

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