(126 days)
No
The device description and performance studies focus on the mechanical properties and materials of a physical implant, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a hemiarthroplasty implant designed to replace the radial head and restore function for patients with degenerative or post-traumatic disabilities, which falls under the definition of a therapeutic device.
No
The device is a hemiarthroplasty implant designed to replace the radial head, which is a therapeutic function, not a diagnostic one. While its indication for use mentions "joint destruction and/or subluxation visible on x-ray," the device itself does not perform the diagnostic imaging or interpretation of results.
No
The device description clearly states it is a "hemiarthroplasty device" and mentions physical components like "head diameters" and "stem diameters," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The BioPoly Radial Head Implant is a physical implant designed to be surgically placed within the human body to replace a damaged radial head.
- Intended Use: The intended use describes the surgical replacement of a joint, not the analysis of biological samples.
This device is a surgical implant or prosthetic device, not an IVD.
N/A
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:
- joint destruction and/or subluxation visible on x-ray; and/or
- resistance to conservative treatment
- Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty
Product codes
KWI
Device Description
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 20mm, 23mm, and 26mm; and stem diameters of 6mm, 7mm, 8mm, +3mm, and +6mm height offsets for
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial head, radio-humeral joint, proximal radio-ulnar joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K183618, K132735, K203634, K222964
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
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.(b)
Classification. Class II.
0
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).
1
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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
| 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
4
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)