BioPoly Lesser Toe Hemiarthroplasty Implant

K222964 · BioPoly, LLC · KWD · Nov 22, 2022 · Orthopedic

Device Facts

• Record ID: K222964
• Device Name: BioPoly Lesser Toe Hemiarthroplasty Implant
• Applicant: BioPoly, LLC
• Product Code: KWD · Orthopedic
• Decision Date: Nov 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioPoly Lesser Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface in patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

Device Story

Hemiarthroplasty implant designed to replace distal metatarsal articular surface; restores joint function in patients with degenerative or post-traumatic arthritis. Device consists of BioPoly (UHMWPE/hyaluronic acid) compression molded onto Ti-6Al-4V stem; optional porous titanium (CP Ti) coating for fixation. Implanted by orthopedic surgeons in clinical settings; requires bone cement for fixation. Provides durable, low-wear articular surface; reduces cartilage wear compared to traditional CoCrMo implants. Benefits patients by alleviating pain and restoring joint stability in MTP joint.

Clinical Evidence

Bench testing only. Testing included initial fixation strength, shear interface strength, fatigue resistance, and wear testing against cartilage. BioPoly material characterized per ASTM F648, ASTM E647, ASTM F748, ASTM F2102, and ASTM D2990. Wear testing showed significantly less wear of BioPoly material and significantly less cartilage wear compared to CoCrMo predicate material.

Technological Characteristics

Implant composed of BioPoly (UHMWPE/hyaluronic acid) molded onto Ti-6Al-4V stem; optional OsteoSync porous CP Ti coating. Materials tested per ASTM F648 (tensile/impact/morphology), ASTM E647 (fatigue), ASTM F748 (density), ASTM F2102 (oxidative index), and ASTM D2990 (creep). Sterilized via ethylene oxide gas.

Indications for Use

Indicated for patients with degenerative/post-traumatic arthritis of the MTP joint, hallux valgus, hallux limitus, hallux rigidus, or unstable/painful MTP joint, provided there is good bone stock and phalangeal base integrity.

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

• Met-Head Resurfacing Hemi-Arthroplasty Implant (K070052)
• Cannulated Hemi Implants (K190543)

Reference Devices

• BioPoly Great Toe Hemiarthroplasty Implant (K203634)

Submission Summary (Full Text)

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November 22, 2022

BioPoly, LLC % Dave McGurl Vice President, Regulatory Affairs - Orthopedics MCRA, LLC 803 7th St. NW, Floor 3 Washington, District of Columbia 20001

Re: K222964

Trade/Device Name: BioPoly Lesser Toe 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: September 26, 2022 Received: September 27, 2022

Dear Dave McGurl:

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 (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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).

Sincerely,

# Ting Song -S

Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222964

#### Device Name

BioPoly Lesser Toe Hemiarthroplasty Implant

Indications for Use (Describe)

The BioPoly Lesser Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface in patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

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

| <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

| Device Trade Name: | BioPoly Lesser Toe Hemiarthroplasty Implant |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | BioPoly, LLC<br>7136 Gettysburg Pike<br>Fort Wayne, IN 46804,<br>USA<br>Phone: [phone] |
| Contact: | Herb Schwartz, Ph.D.<br>BioPoly, LLC<br>7136 Gettysburg Pike<br>Fort Wayne, IN 46804<br>Phone: [phone]<br>[e-mail] |
| Prepared by: | Mr. Dave McGurl<br>Vice President, Regulatory Affairs<br>MCRA, LLC<br>803 7th St NW, Floor 3<br>Washington, DC 20001<br>[phone]<br>[e-mail] |
| Date Prepared: | November 21, 2022 |
| Classification Names: | 21 CFR 888.3730<br>Toe joint phalangeal (hemi-toe) polymer prosthesis |
| Class:<br>Product Codes: | Class II<br>KWD |
| Common Name: | Toe Prosthesis |

# Primary Predicates:

The subject devices are substantially equivalent to the following primary predicate device.

| Predicate Type | Manufacturer | Device Name | K Number |
|----------------|--------------|--------------------------------------------------------------------------------------------|--------------------|
| Primary | Vilex | Met-Head TM, Resurfacing Hemi-Arthroplasty Implant<br>Cannulated Hemi Implants | K070052<br>K190543 |
| Reference | BioPoly | Great Toe Hemiarthroplasty Implant | K203634 |

# Table 1. Predicate Devices

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## Indications for Use:

The BioPoly Lesser Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface in patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

# Device Description:

The BioPoly Lesser Toe Hemiarthroplasty Implant is a hemiarthroplasty device specifically designed to restore the articular surface of the lesser metatarsal bones in patients with degenerative and post-traumatic arthritis.

The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6A1-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.

# Performance Testing Summary:

Initial fixation testing was conducted and demonstrated that the fixation strength of the BioPoly Lesser Toe Hemiarthroplasty Implant met the predetermined acceptance criterion and exceeded the predicate fixation strength.

Shear testing was conducted and demonstrated that the interface strength of the BioPoly Lesser Toe Hemiarthroplasty Implant met the predetermined acceptance criterion.

Fatigue testing was conducted and demonstrated that the fatigue resistance of the BioPoly Lesser Toe Hemiarthroplasty Implant met the predetermined acceptance criterion.

Wear testing against cartilage was conducted and demonstrated that the wear characteristics met the predetermined acceptance criterion. The results showed significantly less wear of the BioPoly material when compared to the predicate material (CoCrMo) against cartilage. Also, the amount of cartilage wear was significantly less when articulating with BioPoly than when articulating with CoCrMo.

The BioPoly Material was characterized according to the FDA guidance and standards including:

- Tensile and impact strength testing per ASTM F648 ●
- Fatigue crack propagation per ASTM E647 .
- Density testing per ASTM F748 ●
- Oxidative index testing per ASTM F2102 ●
- Morphology testing per ASTM F648 .
- Creep testing per ASTM D2990 ●
- Coefficient of Friction testing ●

| 510(k) Summary | BioPoly LLC | Page 2 of 3 |
|----------------|-------------|-------------|
|----------------|-------------|-------------|

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- Pin on disc (POD) testing ●
- Enzyme degradation testing ●

# Sterilization and Cleaning:

The BioPoly Lesser Toe Hemiarthroplasty Implant is provided sterile by ethylene oxide gas. The reusable instruments are provided non-sterile and are required to be steam sterilized prior to use.

## Substantial Equivalence Summary:

The BioPoly Lesser Toe Hemiarthroplasty Implant is substantially equivalent to the predicate device with regards to materials, articular surface area, fixation volume, intended use, and indications.

## Conclusion:

The information and performance data demonstrate that the device is as safe, as effective, and performs as well as or better than the primary predicate device. The subject BioPoly Lesser Toe Hemiarthroplasty Implant is substantially equivalent to the predicate devices (K203634, K070052, and K190543), with respect to indications, design, materials, function, and performance.

| 510(k) Summary | BioPoly LLC | Page 3 of 3 |
|----------------|-------------|-------------|
|----------------|-------------|-------------|