FDA.reportPublic FDA data

HYALEX Slalom™ MTP Hemiarthroplasty System

Primary DI
G712PN00765100
Brand
HYALEX Slalom™ MTP Hemiarthroplasty System
Company
Hyalex Orthopaedics, Inc.
Model
PN-00765-10
Catalog number
PN-00765-10
Device description
HYALEX Slalom™ MTP Hemiarthroplasty Implant, 10mm
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWDProsthesis, Toe, Hemi-, Phalangeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWDProsthesis, Toe, Hemi-, PhalangealOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250074000HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.2026-04-03KWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G712PN00765100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Partial metatarsophalangeal joint prosthesisAn implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal or a metal/polymer combination, and may contain hyaluronic acid; implantation may be performed with or without bone cement. The device is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
781-778-3230customerservice@hyalex.com

Regulatory Flags#

DUNS number
080784794
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G712PN00720100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00720-10PN-00720-102026-06-05
G712PN00720120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00720-12PN-00720-122026-06-05
G712PN00734100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00734-10PN-00734-102026-06-05
G712PN00734120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00734-12PN-00734-122026-06-05
G712PN00763100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00763-10PN-00763-102026-06-05
G712PN00763120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00763-12PN-00763-122026-06-05
G712PN007641HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00764PN-007642026-06-05
G712PN00765120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00765-12PN-00765-122026-06-05
G712PN00774100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00774-10PN-00774-102026-06-05
G712PN00774120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00774-12PN-00774-122026-06-05
G712PN00777100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00777-10PN-00777-102026-06-05
G712PN00777120HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00777-12PN-00777-122026-06-05
G712PN007840HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00784PN-007842026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G712PN00720100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00720120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00734100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00734120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00763100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00763120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN007641HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00765120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00774120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777100HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN00777120HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
G712PN007840HYALEX Slalom™ MTP Hemiarthroplasty SystemHyalex Orthopaedics, Inc.KWD2026-06-05
00810005668095TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668101TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668118TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810005668187TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963565TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00810135963572TrigonNVISION BIOMEDICAL TECHNOLOGIES, INC.KWD2026-04-24
00850044114962Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635037Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635198Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635204Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635211Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635228Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635235Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635242Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635259Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635266Accu-JointAccufix Surgical, Inc.KWD2024-11-11
00850061635273Accu-JointAccufix Surgical, Inc.KWD2024-11-11