# K030344: Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral Heads

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 4, 2003 after 29 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
Longest line of descent: 2 generations back to K790987 (1979). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955767: Cofied Modular Shoulder System, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K003566: Cofield Eccentric and Lateral Offset Humeral Heads, Smith & Nephew, Inc. (2001) Summary page 1.
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 1.
- K982981: New Zimmer Shoulder System, Zimmer, Inc. (1998) Summary page 1.

## Indications for use
Modular Neer 3 Humeral Stems and Humeral Heads are indicated for use as orthopedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. Modular Neer 3 Humeral Stems and Humeral Heads are intended for use with bone cement (cemented fixation) and for single use only. Modular Neer 3 Humeral Stems and Humeral Heads are intended for the following indications: 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, non-union 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.

Source page: https://510kreport.com/device/K030344
Methodology: https://510kreport.com/methodology