BioPoly Great Toe Hemiarthroplasty Implant

K203634 · BioPoly, LLC · KWD · Feb 2, 2021 · Orthopedic

Device Facts

• Record ID: K203634
• Device Name: BioPoly Great Toe Hemiarthroplasty Implant
• Applicant: BioPoly, LLC
• Product Code: KWD · Orthopedic
• Decision Date: Feb 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioPoly Great Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface of the great toe of patients with degenerative and post-traumatic arthritis in the presence of good bone stock 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

Hemi-arthroplasty implant designed to restore articular surface of first metatarsal bone; replaces distal metatarsal surface. Device consists of BioPoly (UHMWPE/hyaluronic acid) compression molded onto Ti-6Al-4V stem; optional porous stem includes OsteoSync Ti (CP Ti). Used in orthopedic surgery; implanted by surgeons. Fixation achieved via bone cement. Provides articular surface for MTP joint; reduces wear on opposing cartilage compared to CoCrMo or Silastic implants. Benefits include improved joint function and pain relief for patients with degenerative or post-traumatic arthritis.

Clinical Evidence

Bench testing only. Performance data includes fixation strength, shear testing, fatigue resistance, and wear testing against cartilage. BioPoly material testing per ASTM standards (F648, E647, F2102, D2990) confirmed tensile/impact strength, density, oxidative index, and creep properties. Wear testing showed significantly less wear of BioPoly material and opposing cartilage compared to CoCrMo and Silastic controls. Coefficient of friction against cartilage was significantly lower than CoCrMo, silicone, and UHMWPE. Bacterial endotoxin levels met acceptance criteria.

Technological Characteristics

Implant materials: BioPoly (UHMWPE/hyaluronic acid) and Ti-6Al-4V stem; optional OsteoSync Ti (CP Ti) porous coating. Hemi-arthroplasty design. Fixation via bone cement. Sterilization: Ethylene oxide (implant); steam sterilization (reusable instruments). Material standards: ASTM F648 (tensile/impact/density/morphology), ASTM E647 (fatigue crack propagation), ASTM F2102 (oxidative index), ASTM D2990 (creep).

Indications for Use

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

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

• Condylar Implant (K781870)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 2, 2021

BioPoly, LLC % Dave McGurl Director, Regulatory Affairs MCRA, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001

Re: K203634

Trade/Device Name: BioPoly Great 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: December 11, 2020 Received: December 11, 2020

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

{1}------------------------------------------------

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,

For Ting Song, Ph.D., R.A.C. 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

#### K203634

Device Name BioPoly Great Toe Hemiarthroplasty Implant

#### Indications for Use (Describe)

The BioPoly Great Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface of the great toe of patients with degenerative and post-traumatic arthritis in the presence of good bone stock 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) | |
|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### K203634

# 510(k) Summary

| Device Trade Name: | BioPoly Great 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>Director, Regulatory Affairs<br>MCRA, LLC<br>1050 K Street NW, Suite 1000<br>Washington, DC 20001<br>[phone]<br>[e-mail] |
| Date Prepared: | January 29, 2021 |
| 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™, Resurfacing Hemi-Arthroplasty Implant<br>Cannulated Hemi Implants | K070052<br>K190543 |
| Reference | Dow Corning H.P. | Condylar Implant | K781870 |

## Predicate Devices

{4}------------------------------------------------

## Indications for Use:

The BioPoly Great Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface of the great toe 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 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 Great Toe Hemiarthroplasty Implant is a hemi-arthroplasty device specifically designed to restore the articular surface of the first metatarsal bone in patients with degenerative and post-traumatic arthritis.

The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6Al-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 Great 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 Great Toe Hemiarthroplasty Implant met the predetermined acceptance criterion.

Fatigue testing was conducted and demonstrated that the fatigue resistance of the BioPoly Great 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 predicate materials (CoCrMo and Silastic) against cartilage. Also, the amount of cartilage wear was significantly less when articulating with BioPoly than when articulating with CoCrMo or Silastic.

The following BioPoly Material testing was conducted:

- Tensile and impact strength testing was conducted and demonstrated that the tensile . properties and impact strength of the BioPoly material meets or exceeds the Type 1 (impact strength) and Type 2 / 3 (tensile) requirements per ASTM F648.
- Fatigue crack propagation testing of the BioPoly material was conducted per ASTM E647. .
- . Density testing was conducted and demonstrated that the density of the BioPoly material meets the Type 1 requirements per ASTM F648.

{5}------------------------------------------------

## K203634

- Oxidative index testing was conducted and demonstrated that the BioPoly material has no measurable oxidative index ("non-detectable") per ASTM F2102.
- Morphology testing per ASTM F648 showed full consolidation of the BioPoly material. ●
- Creep testing per ASTM D2990 showed no difference between BioPoly material and UHMWPE control creep strain and creep modulus.
- Coefficient of Friction testing against cartilage was conducted and demonstrated that the ● BioPoly material CoF with cartilage is significantly lower than that of CoCrMo, silicone, and UHMWPE.
- . Pin on disc (POD) testing was conducted and demonstrated that the wear rate of BioPoly material against cobalt chrome is significantly less than that of UHMWPE control.
- Enzyme degradation testing was conducted and demonstrated that the BioPoly material in its final form is not degraded in the presence of hyaluronidase enzyme.

Bacterial Endotoxin Testing was performed using the Limulus Amebocyte Lysate (LAL) method (ANSI/AAMI ST72:2011/(R)2016, USP<161>, USP <85>, EP 2.6.14, and JP 4.01) and the measured endotoxin levels met the predetermined acceptance criteria. The measured levels were <0.0677 EU/device.

## Sterilization and Cleaning:

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

## Substantial Equivalence Summary:

The BioPoly Great Toe Hemiarthroplasty Implant is substantially equivalent to the predicate device with regards to articular surface area, fixation volume, intended use, and indications. The addition of a porous fixation surface does not raise new types of safety and effectiveness questions, nor are there new technological issues.

## 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 Great Toe Hemiarthroplasty Implant is substantially equivalent to the predicate device (K070052 and K190543). with respect to indications, design, materials, function, and performance,