21 CFR 888.3810 — Prosthesis, Wrist, Hemi-, Ulnar

Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3810

Identification

A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KXEProsthesis, Wrist, Hemi-, Ulnar216Implant
Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...