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 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.

AI/ML Overview

The provided text describes the 510(k) summary for the BioPoly Lesser Toe Hemiarthroplasty Implant, which is a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract the acceptance criteria and performance data for the mechanical testing of the device.

Acceptance Criteria and Device Performance for BioPoly Lesser Toe Hemiarthroplasty Implant

Acceptance Criteria Category	Device Performance (Reported)
Initial Fixation Strength	Met the predetermined acceptance criterion and exceeded the predicate fixation strength.
Shear Testing (Interface Strength)	Met the predetermined acceptance criterion.
Fatigue Testing (Fatigue Resistance)	Met the predetermined acceptance criterion.
Wear Testing (Against Cartilage)	Met the predetermined acceptance criterion. The results showed significantly less wear of the BioPoly material when compared to the predicate material (CoCrMo) against cartilage. Additionally, the amount of cartilage wear was significantly less when articulating with BioPoly than when articulating with CoCrMo.

Explanation for non-applicable AI/ML categories:

Sample size used for the test set and the data provenance: Not applicable. This concerns mechanical testing of a physical implant, not data-driven evaluation of an AI/ML model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established through standardized engineering tests, not expert consensus on medical images or clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No human reader involvement or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance claims is based on established engineering test standards and predefined acceptance criteria for mechanical properties (e.g., fixation strength, shear strength, fatigue resistance, wear characteristics).
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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, LLC7136 Gettysburg PikeFort Wayne, IN 46804,USAPhone: (260) 417-2209
Contact:	Herb Schwartz, Ph.D.BioPoly, LLC7136 Gettysburg PikeFort Wayne, IN 46804Phone: (260) 417-2209herb.schwartz@schwartzbiomedical.com
Prepared by:	Mr. Dave McGurlVice President, Regulatory AffairsMCRA, LLC803 7th St NW, Floor 3Washington, DC 20001(202) 552-5797dmcgurl@mcra.com
Date Prepared:	November 21, 2022
Classification Names:	21 CFR 888.3730Toe joint phalangeal (hemi-toe) polymer prosthesis
Class:Product Codes:	Class IIKWD
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 ImplantCannulated Hemi Implants	K070052 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:

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
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Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
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.(b)
Classification. Class II.