HYALEX® MTP Hemiarthroplasty Implant

K250074 · Hyalex Orthopaedics, Inc. · KWD · Apr 3, 2026 · Orthopedic

Device Facts

• Record ID: K250074
• Device Name: HYALEX® MTP Hemiarthroplasty Implant
• Applicant: Hyalex Orthopaedics, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Apr 3, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The HYALEX® MTP Hemiarthroplasty Implant is intended to be implanted to replace the distal metatarsal surface of the great toe for treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus, hallux limitus, or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is intended for single use and for use without bone cement.

Device Story

Implant replaces distal metatarsal surface of great toe; relieves pain from degenerative/post-traumatic arthritis. System includes implant and instrumentation. Implant features HYALEX bearing material (polyurethane/polyacrylic acid) bonded to titanium coating (Ti6Al4V/commercially pure titanium) via proprietary bonding compound (PMMA/UDMA); porous titanium surface facilitates bone ingrowth. Implanted by trained foot and ankle surgeons; uncemented; utilizes interference fit for stability. Supplied sterile in 10mm and 12mm diameters. Benefits include restoration of articular surface while retaining surrounding cartilage/bone and preserving sesamoid grooves.

Clinical Evidence

Bench testing included implant insertion assessment, anatomic fatigue, micromotion, wear, contact pressure, biocompatibility, and MRI compatibility. Design validation performed in cadavers by foot and ankle surgeons. One-year large animal study demonstrated in vivo stability and durability of bearing material.

Technological Characteristics

Implant materials: polyurethane, polyacrylic acid, Ti6Al4V, commercially pure titanium, PMMA, UDMA. Form factor: 10mm and 12mm diameter caps. Fixation: uncemented, interference fit. Sterilization: radiation (SAL 10⁻⁶). Instrumentation: reusable, steam sterilized.

Indications for Use

Indicated for patients with degenerative or post-traumatic arthritis of the first MTP joint with good bone stock, including hallux valgus, hallux limitus, or hallux rigidus, and unstable or painful MTP joint.

Regulatory Classification

Identification

A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.

Predicate Devices

• HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant (K131377)

Reference Devices

• BioPoly Great Toe Hemiarthroplasty Implant (K203634)

Submission Summary (Full Text)

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**U.S. FOOD & DRUG**
ADMINISTRATION

April 3, 2026

Hyalex Orthopaedics, Inc.
Chris Cain
VP of Clinical and Regulatory Affairs
9 Hayden Ave. Bldg. D, Suite 340
Lexington, Massachusetts 02421

Re: K250074

Trade/Device Name: HYALEX® MTP Hemiarthroplasty Implant
Regulation Number: 21 CFR 888.3730
Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis
Regulatory Class: Class II
Product Code: KWD
Dated: January 2, 2026
Received: January 2, 2026

Dear Chris Cain:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250074 - Chris Cain

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K250074 - Chris Cain

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Sincerely,

# STANLEY GOLISH-S

for RDML Raquel Peat, PhD, MPH, USPHS

Director

OHT6: Office of Orthopedic Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# **Indications for Use**

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250074

Device Name
HYALEX® MTP Hemiarthroplasty Implant

Indications for Use (Describe)

The HYALEX® MTP Hemiarthroplasty Implant is intended to be implanted to replace the distal metatarsal surface of the great toe for treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus, hallux limitus, or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is intended for single use and for use without bone cement.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)

☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.

# I. Submitter Information

Manufacturer: Hyalex Orthopaedics, Inc.
99 Hayden Ave., Bldg. D, Ste. 340
Lexington, MA 02421 USA
Phone: [phone]

Contact: Chris Cain
Hyalex Orthopaedics, Inc.
Phone: [phone]
[e-mail]

Date Prepared: 3 April 2026

# II. Name of Device

Device Trade Name: HYALEX® MTP Hemiarthroplasty Implant
Common Name: Toe Prosthesis
Regulation Name: Toe Joint Phalangeal (Hemi-Toe) Polymer Prosthesis
Regulation Number: 21 CFR 888.3730
Product Code: KWD
Device Class: Class II
Panel Identification: Orthopedics

# III. Predicate Devices

| Predicate Type | Device Name | Manufacturer | 510(k) No. |
| --- | --- | --- | --- |
| Predicate Device (Primary) | HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant | ArthroSurface, Inc. | K131377 |
| Reference Device | BioPoly Great Toe Hemiarthroplasty Implant | BioPoly, LLC | K203634 |

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#### IV. Device Description

The system is composed of the HYALEX Implant and instrumentation. The implant restores the damaged portion of the metatarsal head to relieve pain from degenerative or post-traumatic arthritis.

The implant consists of the HYALEX bearing material (polyurethane and polyacrylic acid) bonded with a titanium coating (Ti6Al4V and commercially pure titanium) using HBC (PMMA and UDMA), a proprietary bonding compound. The device has porous titanium (commercially pure titanium) to allow bone ingrowth. The implant is supplied sterile in two sizes with a cap diameter of 10 and 12mm.

The implant is intended for single use only and should not be reused or re-sterilized. It should only be implanted by a trained and qualified foot and ankle surgeon.

#### V. Intended Use

The HYALEX MTP Hemiarthroplasty Implant is intended for use in the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock.

#### VI. Indications for Use

The HYALEX® MTP Hemiarthroplasty Implant is intended to be implanted to replace the distal metatarsal surface of the great toe for treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus, hallux limitus, or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is intended for single use and for use without bone cement.

#### VII. Comparison of Technological Characteristics with the Predicate Device

The subject and predicate device have the same intended use and indications for use. Both devices replace the articular surface of the metatarsal head while retaining surrounding cartilage and bone and preserving the sesamoid grooves. Both implants utilize a similar surgical technique, are uncemented and utilize an interference fit with the bone for implant stability. The articular surface of the HYALEX MTP Hemiarthroplasty Implant is made from polyurethane and polyacrylic acid while the predicate device has a CoCr surface. The testing described in the prior section has shown that the known questions of safety and effectiveness concerning wear, durability and biocompatibility of the articular surface of the HYALEX MTP Hemiarthroplasty Implant performs as required per recognized acceptance criteria. The HYALEX MTP Hemiarthroplasty Implant is substantially equivalent to the predicate device.

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### VIII. Performance Testing Summary

Performance testing was conducted on the HYALEX MTP Hemiarthroplasty Implant, including implant insertion assessment, anatomic fatigue, micromotion assessment, implant wear assessment, contact pressure assessment, biocompatibility and MRI compatibility. Design validation testing was conducted in cadavers by practicing foot and ankle surgeons.

A one-year large animal study was also conducted to illustrate the stability and durability of the bearing material in vivo. Results from this study provided evidence of the safety of the implant material.

The HYALEX MTP Hemiarthroplasty Implant is sterilized by radiation to a Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with a validated process. The instrumentation is reusable and is cleaned and sterilized between uses according to a validated cleaning and steam sterilization process.

### IX. Substantial Equivalence Summary

The HYALEX MTP Hemiarthroplasty Implant is substantially equivalent to the primary predicate device, HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant, on the basis of the following:

- The subject device has the SAME intended use as the predicate device; AND
- The subject device is as safe and effective as the predicate device; AND
- The subject device has some differences in technological characteristics compared to the predicate, but those differences do not raise different questions of safety and effectiveness.

The data presented in this 510(k) supports these assertions. Therefore, the HYALEX MTP Hemiarthroplasty Implant is substantially equivalent to the predicate device and meets the requirements for 510(k) clearance.

### X. Conclusion

The HYALEX MTP Hemiarthroplasty Implant is substantially equivalent to the predicate devices; and does not raise any different questions of safety or effectiveness. To address the possibility of device dissociation, a 522 Order for a Post Market Surveillance Study will be issued for this device.

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