510(k) Report

Devices descending from K041595

21 later devices reach Toe MP Joint, Models 10412-10414, 14958, 14960… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182704WishBone Guided Growth SystemWishbone Medical201901
+1K121973Biopro Hemi-Edge Toe SystemBiopro, Inc.20122—
+1K102401Hemi Implant; Mini Hemi ImplantVilex, Inc.201111—
+1K083469Metasurg Cannulated Tiatanium Hemi Implant, Model HM-1000Metasurg200912—
+1K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP200815—
+1K063058Arthrex Anatoemic Phalangeal ProsthesisArthrex, Inc.20070—
+1K060536Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP200616—
+2K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+2K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195—
+2K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.20139—
+2K131187Lesser Metatarsal Head Implant SystemSolana Surgical, LLC20130—
+2K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC201210—
+2K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP200813—
+3K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.20260—
+3K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—
+3K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+3K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+3K190261BOSS Toe Fixation SystemArthrosurface, Inc.20190—
+3K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc.20170—
+3K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.20166—
+4K233592BioPoly Radial Head ImplantBioPoly, LLC20240—