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.

Device Description

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 stems are offered in short and long lengths. The heads are offered in heights of standard, +2 and +4 configurations. The implant allows for replacement of the radial head.

AI/ML Overview

The provided text describes the Avenger Radial Head System, a medical device, and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding AI/algorithm performance. The document focuses on regulatory clearance based on substantial equivalence to predicate devices and general performance testing (mechanical and biocompatibility).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth types related to an AI device.

The document primarily discusses:

Device Name: Avenger Radial Head System
Intended Use/Indications for Use: Replacement of the proximal end of the radius for various conditions (degenerative/post-traumatic disabilities, radial head fracture, sequelae after radial head resection, revision of failed arthroplasty). The components are intended for uncemented use.
Regulatory Information: Class II device, Regulation Number 21 CFR 888.3170 (Elbow joint radial (hemi elbow) polymer prosthesis), Product Code KWI.
Material: Cobalt chrome (ASTM F 1537) for the head and stem components.
Substantial Equivalence: Demonstrated to be substantially equivalent to previously cleared devices (Wright Medical Evolve® Modular Radial Head - K060731, K991915; Stryker (SBI/Avanta) Radial Head - K982288) based on similar indications, materials, and geometry.
Performance Testing (Mechanical/Biocompatibility):
- Head disassembly (ASTM F2009)
- Fatigue testing (ASTM F2887)
- Bacterial endotoxin testing (LAL)

No information regarding AI, algorithm performance, or the other specific points requested is available in the provided text.

Summary

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January 7, 2020

In2Bones USA, LLC Christine Scifert VP of Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis, Tennessee 38119

Re: K192754

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: December 4, 2019 Received: December 6, 2019

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

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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,

Vesa Vuniqi 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)

K192754

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)
-------------------------------------------------

X 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 January 6, 2020

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

Device Description: 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 stems are offered in short and long lengths. The heads are offered in heights of standard, +2 and +4 configurations. 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

. K060731 – Wright Medical Evolve® Modular Radial Head
Additional Predicates
K991915 – Wright Medical Evolve® Modular Radial Head
. K982288 – Stryker (SBI/Avanta) 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) and fatigue testing (ASTM F2887) were performed for the Avenger Radial Head System. Bacterial endotoxin testing (LAL) was performed.

Conclusion

Based on the test results and the comparison to the predicate device is determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.