(142 days)
The Ignite Orthopedics Revolution Radial Head 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.
The Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length.
The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537.
The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
This is a 510(k) premarket notification for the Revolution Radial Head, a medical device for radial head replacement. The provided document is a clearance letter from the FDA, a 510(k) summary, and indications for use. It details the device's characteristics and its substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength | Bending stress analysis demonstrated that the strength of the worst-case Revolution Radial Head is greater than the strength of the worst-case predicate device and is adequate for its intended use. |
| Endotoxin Level | Endotoxin testing of worst-case samples using the Limulus amebocyte lysate (LAL) method demonstrated an endotoxin level of |
§ 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.