FDA.reportPublic FDA data

510(k) K250074

Device
HYALEX® MTP Hemiarthroplasty Implant
Applicant
Hyalex Orthopaedics, Inc.
510(k) number
K250074
Product code
KWD
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-03
Date received
2025-01-10
Regulation
888.3730
Classification name
Prosthesis, Toe, Hemi-, Phalangeal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Chris Cain
Address
99 Hayden Ave. Bldg. D, Suite 340 Lexington MA US 02421 02421

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.2024-02-29
K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity Medical2023-04-19
K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC2022-11-22
K201393restor3d MTP ImplantRestor3D, Inc.2022-05-25
K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC2021-02-02
K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.2020-12-08
K190261BOSS Toe Fixation SystemArthrosurface, Inc.2019-08-14
K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.2019-05-31
K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc.2017-02-01
K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.2016-04-11
K131377HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTArthrosurface, Inc.2013-11-19
K131187LESSER METATARSAL HEAD IMPLANT SYSTEMSolana Surgical, LLC2013-10-22
K121973BIOPRO HEMI-EDGE TOE SYSTEMBiopro, Inc.2012-10-30
K113752METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SETSolana Surgical, LLC2012-02-06
K120029HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SETSolana Surgical, LLC2012-02-06