(99 days)
The Avenger Radial Head System is intended for replacement of the proximal end of the radius:
• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-humeral and/or proximal radio-ulnar joint with:
- a. Joint destruction and/or subluxation visible on x-ray; and/or
- b. Resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty.
The components are intended for uncemented use.
The Avenger Radial Head System is a two-piece modular system comprised of cobalt chrome (ASTM F 1537) head and stem components. The system consists of a range of lengths and diameters for the stem as well as heads in a range of diameters and heights to accommodate the patient anatomy. The subject of this 510(k) is to clear a new range of stem implants (+4mm offset stems) that can be used to extend the current range of the Avenger Radial Headle modular system. The implant allows for replacement of the radial head.
The provided document describes the clearance of the "Avenger Radial Head System" by the FDA. However, it does not include detailed information regarding acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to previously cleared predicate devices. It mentions "Performance Testing: Head disassembly (ASTM F2009) was performed for the Avenger Radial Head System, +4mm offset stems comparing to the previously cleared K192754 devices. Fatigue testing, sterilization and endotoxin testing were able to adopt into the previously cleared devices." This indicates that some performance testing was done, but the specific acceptance criteria and the quantitative results are not provided in this document.
Therefore, I cannot populate the table or answer most of your specific questions based on the input text.
Information NOT available in the provided document:
- A table of acceptance criteria and the reported device performance: While performance testing related to head disassembly, fatigue, sterilization, and endotoxin is mentioned, the specific acceptance criteria (e.g., maximum force for disassembly, number of cycles for fatigue) and the actual reported device performance values are not detailed.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical medical device (radial head prosthesis) and not an AI/diagnostic software.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a physical medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For a physical device, "ground truth" typically refers to established engineering standards or physical measurements, which are implied by the mention of ASTM F2009 and other testing, but not explicitly detailed as "ground truth."
- The sample size for the training set: Not applicable for a physical device.
- How the ground truth for the training set was established: Not applicable for a physical device.
What is available (though limited in detail):
- Study that proves the device meets the acceptance criteria: Performance Testing, including "Head disassembly (ASTM F2009)," "Fatigue testing," "sterilization," and "endotoxin testing." The document states these tests were performed and were "able to adopt into the previously cleared devices," suggesting the results were consistent with or met the requirements established for the predicate devices.
- Type of device: Physical medical device (radial head prosthesis).
- Indications for Use: Replacement of the proximal end of the radius for various conditions, including degenerative/post-traumatic disabilities, primary replacement after fracture, symptomatic sequelae after radial head resection, and revision after failed arthroplasty. Intended for uncemented use.
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December 17, 2021
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In2Bones USA, LLC Christine Scifert VP of Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis. Tennessee 38119
Re: K212872
Trade/Device Name: Avenger Radial Head System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: Class II Product Code: KWI Dated: November 1, 2021 Received: November 3, 2021
Dear Christine Scifert:
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 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
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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 (QS) 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.
For Jiping Chen, Ph.D., M.P.H. Acting Division 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) K212872
Device Name Avenger Radial Head System
Indications for Use (Describe)
The Avenger Radial Head System is intended for replacement of the proximal end of the radius:
• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-humeral and/or proximal radio-ulnar joint with:
- a. Joint destruction and/or subluxation visible on x-ray; and/or
- b. Resistance to conservative treatment.
- · Primary replacement after fracture of the radial head.
- · Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty.
The components are intended for uncemented use.
| 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) Summary
Avenger Radial Head System September 2, 2021
| Company: | In2Bones USA, LLC6000 Poplar Ave, Suite 115Memphis, TN 38119901-260-7931 |
|---|---|
| Primary Contact: | Christine Scifert |
| Company Contact: | Rebecca Wahl |
| Trade Name: | Avenger Radial Head System |
| Common Name: | Modular Radial Head |
| Classification: | II |
| Regulation Number: | 21 CFR 888.3170, Elbow joint radial (hemi elbow) polymer prosthesis |
| Panel: | 87-Orthopedic |
| Product Code(s): | KWI |
The Avenger Radial Head System is a two-piece modular system comprised of cobalt chrome Device Description: (ASTM F 1537) head and stem components. The system consists of a range of lengths and diameters for the stem as well as heads in a range of diameters and heights to accommodate the patient anatomy. The subject of this 510(k) is to clear a new range of stem implants (+4mm offset stems) that can be used to extend the current range of the Avenger Radial Headle modular system. The implant allows for replacement of the radial head.
Indications for Use
Intended Use:
The Avenger Radial Head System is intended for replacement of the proximal end of the radius:
- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-humeral and/or proximal radio-ulnar joint with:
- a. Joint destruction and/or subluxation visible on x-ray; and/or
- b. Resistance to conservative treatment.
- Primary replacement after fracture of the radial head.
- Symptomatic sequelae after radial head resection.
- Revision following failed radial head arthroplasty. ●
The components are intended for uncemented use.
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Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate
-
. K192754 – In2Bones Avenger Radial Head System
Additional Predicates -
. K991915, K060731 - Wright Medical Evolve® Modular Radial Head
The subject Avenger Radial Head is made of cobalt chrome and has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry.
Performance Testing: Head disassembly (ASTM F2009) was performed for the Avenger Radial Head System, +4mm offset stems comparing to the previously cleared K192754 devices. Fatigue testing, sterilization and endotoxin testing were able to adopt into the previously cleared devices.
Conclusion
Based on the test results and the comparison to the predicate device is determined to be substantially equivalent to the predicate devices.
§ 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.