# K994350: Neer Iii Total Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: May 23, 2000 after 152 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Neer II Total Shoulder System - 3M: named in the summary without a submission number
- (no number) Modular Total Shoulder System — 3M: named in the summary without a submission number
- (no number) Aequalis Shoulder System — Tornier S.A.: named in the summary without a submission number
- (no number) Neer II UHMWPE glenoid component: named in the summary without a submission number

## Indications for use
The Neer III Total Shoulder System is indicated for use as an orthopedic implant for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. The Neer III Total Shoulder System is intended for the following: Proximal Humeral Prosthesis - (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g., trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities. Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) — severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis,avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. This device is intended only for cemented fixation.

Source page: https://510kreport.com/device/K994350
Methodology: https://510kreport.com/methodology