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K Number
K192754
Device Name
Avenger Radial Head System
Manufacturer
In2Bones USA, LLC
Date Cleared
2020-01-07

(99 days)

Product Code
KWI
Regulation Number
888.3170
Type
Traditional
Panel
OR
Reference & Predicate Devices
K060731,K991915,K982288
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

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.

§ 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.