(99 days)
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No
The document describes a mechanical implant for radial head replacement and does not mention any AI or ML components or functionalities.
Yes
The device is a prosthetic implant used to replace a damaged radial head, which is a therapeutic intervention aimed at restoring function and alleviating symptoms.
No
Explanation: The device is an implantable system for radial head replacement, not designed to diagnose disease or conditions.
No
The device description clearly states it is a "two-piece modular system comprised of cobalt chrome (ASTM F 1537) head and stem components," 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Avenger Radial Head System Function: The Avenger Radial Head System is a surgical implant designed to replace a damaged or diseased radial head (part of the elbow joint). It is physically implanted into the patient's body.
- Intended Use: The intended use clearly states it's for "replacement of the proximal end of the radius" due to various conditions. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a modular system of cobalt chrome components designed for implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The Avenger Radial Head System is a Class II or Class III medical device (depending on the specific classification) used in orthopedic surgery.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
proximal end of the radius, radial-humeral and/or proximal radio-ulnar joint
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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)
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.
- · 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:
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, LLC
6000 Poplar Ave, Suite 115
Memphis, TN 38119
901-260-7931 |
|--------------------|--------------------------------------------------------------------------------------|
| 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.