(56 days)
No
The summary describes a physical implant device and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is an implant intended to replace a joint surface in patients with arthritis, which is a therapeutic function.
No
Explanation: The device is described as an implant intended to replace a joint surface, which is a therapeutic function, not a diagnostic one. It is used to treat conditions, not to identify or assess them.
No
The device description clearly states it is an implant comprised of physical materials (UHMWPE/hyaluronic acid and Ti-6A1-4V) and is intended to replace a physical anatomical structure (distal metatarsal surface). It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a surgical implant intended to replace a joint surface in the foot. It is a physical device implanted into the body, not used to test samples outside the body.
The device is a surgical implant used for orthopedic purposes.
N/A
Intended Use / 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 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.
Product codes
KWD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal metatarsal surface in the MTP joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Pin on disc (POD) testing
- Enzyme degradation testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains 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.
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
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 (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)
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) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Device Trade Name: | BioPoly Lesser Toe Hemiarthroplasty Implant |
|---|---|
| Manufacturer: | BioPoly, LLC |
| 7136 Gettysburg Pike | |
| Fort Wayne, IN 46804, | |
| USA | |
| Phone: (260) 417-2209 | |
| Contact: | Herb Schwartz, Ph.D. |
| BioPoly, LLC | |
| 7136 Gettysburg Pike | |
| Fort Wayne, IN 46804 | |
| Phone: (260) 417-2209 | |
| herb.schwartz@schwartzbiomedical.com | |
| Prepared by: | Mr. Dave McGurl |
| Vice President, Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th St NW, Floor 3 | |
| Washington, DC 20001 | |
| (202) 552-5797 | |
| dmcgurl@mcra.com | |
| Date Prepared: | November 21, 2022 |
| Classification Names: | 21 CFR 888.3730 |
| Toe joint phalangeal (hemi-toe) polymer prosthesis | |
| Class: | |
| Product Codes: | Class II |
| 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 | |
| Cannulated 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:
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 |
|---|---|---|
| ---------------- | ------------- | ------------- |