510(k) Report

Devices descending from K813554

41 later devices reach Ace/Kyle Captured Hip Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+1K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+1K063509Depuy Peak FX Hip PlateDePuy Orthopaedics, Inc.200735—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K173746Activmotion RangeNewclip Technics20181—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241539Activmotion SNewclip Technics20240—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—