BioPoly Radial Head Implant
Device Facts
| Record ID | K233592 |
|---|---|
| Device Name | BioPoly Radial Head Implant |
| Applicant | BioPoly, LLC |
| Product Code | KWI · Orthopedic |
| Decision Date | Mar 13, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3170 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The BioPoly Radial Head Implant is indicated for: • Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with: o joint destruction and/or subluxation visible on x-ray; and/or o resistance to conservative treatment • Primary replacement after fracture of the radial head • Symptomatic sequelae after radial head resection • · Revision following failed radial head arthroplasty
Device Story
BioPoly Radial Head Implant is a hemiarthroplasty device designed to restore articular surface and spacing of the proximal radius head. Used in orthopedic surgery for patients with degenerative or post-traumatic radial head disabilities or fractures. Device consists of a head and stem; available in multiple diameters and height offsets. Implanted by orthopedic surgeons to replace damaged radial head tissue, aiming to reduce pain and restore joint motion. Operates as a mechanical prosthesis; provides a bearing surface for the radio-humeral and proximal radio-ulnar joints. Clinical benefit includes restoration of joint function and relief of symptoms associated with radial head pathology.
Clinical Evidence
Bench testing only. Testing included shear testing of head-to-stem interface, fatigue testing, and wear testing against both cartilage and CoCr. BioPoly material characterized per ASTM F648 (tensile/impact/morphology), ASTM E647 (fatigue crack), ASTM F748 (density), ASTM F2102 (oxidative index), and ASTM D2990 (creep). Additional testing included coefficient of friction, pin-on-disc, and enzyme degradation.
Technological Characteristics
Hemiarthroplasty radial head prosthesis; uncemented fixation; concave spherical articulating surface. Materials characterized per ASTM F648, ASTM E647, ASTM F748, ASTM F2102, and ASTM D2990. Available in head diameters of 20mm, 23mm, 26mm; stem diameters of 6mm, 7mm, 8mm; and +3mm/+6mm height offsets.
Indications for Use
Indicated for patients requiring radial head replacement due to degenerative or post-traumatic disabilities (pain, crepitation, decreased motion, joint destruction, subluxation), primary fracture, symptomatic sequelae post-resection, or revision of failed radial head arthroplasty.
Regulatory Classification
Identification
An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
Predicate Devices
- Revolution Radial Head (K183618)
- Axia Radial Head System (K132735)
- BioPoly Great Toe Hemiarthroplasty Implant (K203634)
- BioPoly Lesser Toe Hemiarthroplasty Implant (K222964)
Related Devices
- K041858 — ACUMED ANATOMIC RADIAL HEAD SYSTEM · Acumed, LLC · Oct 5, 2004
- K982288 — RADIAL HEAD IMPLANT · Avanta Orthopaedics, Inc. · Sep 8, 1998
- K183618 — Revolution Radial Head · Ignite Orthopedics, Inc. · May 17, 2019
- K062898 — SBI LATERAL RHEAD IMPLANT · Small Bone Innovations, Inc. · Nov 13, 2006
- K992220 — RADIAL HEAD PROSTHESIS · Smith & Nephew, Inc. · Feb 25, 2000
Submission Summary (Full Text)
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March 13, 2024
Image /page/0/Picture/1 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.
BioPoly, LLC Jacob Alumbaugh Senior Product Development Engineer 7136 Gettysburg Pike Fort Wayne, Indiana 46804
Re: K233592
Trade/Device Name: BioPoly Radial Head Implant Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: Class II Product Code: KWI Dated: February 20, 2024 Received: February 21, 2024
Dear Jacob Alumbaugh:
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" (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).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-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.
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-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, Joseph P. Russell Digitally signed by Joseph P. Russell -S -2 Date: 2024.03.13 16:24:43 -04'00' for: Farzana Sharmin, PhD 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K233592
Device Name
BioPoly Radial Head Implant
#### Indications for Use (Describe)
The BioPoly Radial Head Implant is indicated for:
- · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain. crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment
- · Primary replacement after fracture of the radial head
- · Symptomatic sequelae after radial head resection
- · Revision following failed radial head arthroplasty
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) #: | K233592 | 510(k) Summary | Prepared on: | 2024-03-12 |
|-----------|---------|----------------|--------------|------------|
|-----------|---------|----------------|--------------|------------|
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | BioPoly, LLC |
|---------------------------------|--------------------------------------------------------|
| Applicant Address | 7136 Gettysburg Pike Fort Wayne IN 46804 United States |
| Applicant Contact Telephone | 2604172209 |
| Applicant Contact | Dr. Schwartz Herb |
| Applicant Contact Email | herb@biopolyortho.com |
| Correspondent Name | BioPoly, LLC |
| Correspondent Address | 7136 Gettysburg Pike Fort Wayne IN 46804 United States |
| Correspondent Contact Telephone | 2176638048 |
| Correspondent Contact | Mr. Alumbaugh Jacob |
| Correspondent Contact Email | jacob@biopolyortho.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | BioPoly Radial Head Implant |
|---------------------|----------------------------------------------------|
| Common Name | Elbow joint radial (hemi-elbow) polymer prosthesis |
| Classification Name | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Regulation Number | 888.3170 |
| Product Code | KWI |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-------------|----------------------------------------------------------|--------------|
| K183618 | Revolution Radial Head | KWI |
| K132735 | Axia Radial Head System | KWI |
| K203634 | BioPoly Great Toe Hemiarthroplasty Implant | KWD |
| K222964 | BioPoly Lesser Toe Hemiarthroplasty Implant | KWD |
Device Description Summary
21 CFR 807.92(a)(4)
The BioPoly Radial Head Implant is a hemiarthroplasty device designed to restore the articular surface and spacing of the proximal head of the radius in patients following fracture resection and/or degenerative disability The implant is supplied with head diameters of
of the radius in patients following fracture, resection, and/or degenerative disability. The implant is supplied with head diameters of 20mm, 23mm, and 26mm; and stem diameters of 6mm, 7mm, 8mm, +3mm, and +6mm height offsets for
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## Intended Use/Indications for Use
The BioPoly Radial Head Implant is indicated for:
• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment
- Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection
- · Revision following failed radial head arthroplasty
## Indications for Use Comparison
The BioPoly Radial Head has identical Indications for Use to the predicate device
## Technological Comparison
Technological Characteristics:
The BioPoly Radial Head Implant has the following identical features to the Ignite Orthopedics Revolution Radicate: • Method of Fixation (none - uncemented fixation)
- · Articulating Geometry (concave spherical surface)
· Stem Design
- · Head diameters (offered within the range of sizes of the predicate)
- Height Offset
- Site Preparation
There are four differences between the subject and predicate devices: the head-to-stem connection, the head diameters, and the stem sizes, but these different questions of safety and effectiveness. Both the subject and predicate devices are hemiarthroplasty devices.
#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Shear testing was conducted and demonstrated that the head-to-stem interface strength of the BioPoly Radial Head Implant met the predetermined acceptance criterion.
Fatigue testing was conducted and demonstrated that the fioPoly Radial Head Implant met the predetermined acceptance criterion.
Wear testing against cartilage was conducted and demonstrated that the wear characteristics met the predetermined acceptance criterion.
Wear testing against CoCr was conducted and demonstrated that the risks of wear-through, cracking, or delamination are minimized through the lifetime of the device.
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
The subject BioPoly Radial Head implant is substantially equivalent to the predicate device (K183618) with respect to indications, design, materials, function, and performance.
## 21 CFR 807.92(a)(5)
# 21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
