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The BioPoly Radial Head Implant 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 BioPoly Radial Head Implant is a hemiarthroplasty device designed to restore the articular surface and spacing of the proximal head of the radius in patients following fracture resection and/or degenerative disability The implant is supplied with head diameters of 20mm, 23mm, and 26mm; and stem diameters of 6mm, 7mm, 8mm, +3mm, and +6mm height offsets for the radius in patients following fracture, resection, and/or degenerative disability.

The Align Radial Head System and accessories are designed specifically 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. - 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 system is intended for press fit use.

The subject Align Radial Head System and the predicate Align Radial Head System (K172688) are a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. It consists of cobalt chrome modular heads in different sizes with cobalt chrome locking screws, titanium alloy stems, necks, and specialized instrumentation.

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: joint destruction and/or subluxation visible on x-ray; and/or resistance to conservative treatment. Primary replacement after fracture of the radial head. Symptomatic sequelae after radial head resection. Revision following failed radial head arthroplasty.

This document is regarding the DePuy Synthes Radial Head Replacement System-MR Conditional. The Radial Head Replacement System Implant 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 Radial Head is manufactured from wrought CoCrMo alloy. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone. The devices in scope of the subject submission are being reviewed for MR Conditional labeling in addition to the previously cleared 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.

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 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 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.

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.

The Align Radial Head System and accessories are designed specifically 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, - 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 system is intended for press fit use.

The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit. Combined with its unique instrumentation, the Align Radial Head System offer the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved. The Align Radial Head System is comprised of: - · Multiple sized CoCr Radial Heads with Locking Screw - Multiple sized titanium alloy Stems, titanium plasma spray coated - · System specific instrumentation.

Radial head arthroplasty The Axia Radial Head System is intended to reduce or relieve pain and restore function and motion to the elbow. - Radial head replacement for degenerative or post-traumatic disabilities when presenting with . pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with: - 0 Joint destruction and/or subluxation - Resistance to conservative treatment O . - Primary radial head replacement after fracture - Symptomatic sequelae after radial head resection ◆ - Revision following failed radial head arthroplasty . CAUTION: This device is intended for uncemented use only.

The Axia Radial Head System is a 2-part system comprised of a radial head implant and a radial stem implant. There are 6 sizes of radial heads and 6 sizes of stem implant is available in 3 offset sizes. The large combination of implant sizes and the amount size interchangeability in the system allows for better reproduction of individual patient anatomy. The Axia Radial Head System radial head implants are made from cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. The radial head stems are made from titanium alloy (Ti-6Al-4V).

The Acumed Anatomic Radial Head System, the Acumed Anatomic Radial Head Long Stems, the Acumed ARH Slide-Loc™ System, and accessories are designed specifically for: 1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, resistance to conservative treatment. 2. Primary replacement after fracture of the radial head. 3. Symptomatic sequelae after radial head resection. 4. Revision following failed radial head arthroplasty. The device is intended to be press fit or cemented.

The Acumed Anatomic Radial Head Long Stems and the Acumed ARH Slide-Loc "" System include modular heads and stems with accessories to anatomically replace the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.

The Synthes Radial Head Prosthesis System is intended for: 1. The 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 a. Joint destruction and/or subluxation visible on x-ray b. Resistance to conservative treatment 2. Primary replacement after fracture of the radial head. 3. Symptomatic sequelae after radial head resection 4. Revision following failed radial head arthroplasty.

The Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.