FDA.reportPublic FDA data

HYALEX Slalom™ MTP Hemiarthroplasty System

Primary DI
G712PN00734100
Brand
HYALEX Slalom™ MTP Hemiarthroplasty System
Company
Hyalex Orthopaedics, Inc.
Model
PN-00734-10
Catalog number
PN-00734-10
Device description
HYALEX Slalom™ MTP Hemiarthroplasty Trial, 10mm
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
G712PN00734100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
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
G712PN00765100HYALEX Slalom™ MTP Hemiarthroplasty SystemPN-00765-10PN-00765-102026-06-05
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
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
G712PN00765100HYALEX 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
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