# K012378: 3D Humeral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 13, 2001 after 140 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) Aequalis™ Shoulder System — Tornier, S.A.: named in the summary without a submission number
- (no number) Anatomica Humeral Stems/Heads — Sulzer Orthopedics: named in the summary without a submission number

## Indications for use
When used with an appropriate humeral stem from the Cofield? Total Shoulder System, 3D 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 from the Cofield” or Neer Il Total Shoulder Systems, respectively. When used with an appropriate humeral stem, 3D Humeral Heads are intended for use with bone cement only (j.¢. cemented fixation) and for single use only. 3D 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-ugion 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 as described above) — severe destruction of the glenohumeral articular surfaces with intractable chronic pain in theumatoid 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/K012378
Methodology: https://510kreport.com/methodology