# K012788: Vaporized Hydrogen Peroxide (VHP) Sterilization of Unmwpe Components in the Cofield Total Shoulder System, the Neer II

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 15, 2002 after 207 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Cofield Total Shoulder System: named in the summary without a submission number
- (no number) Neer II Total Shoulder System: named in the summary without a submission number
- (no number) Neer III Total Shoulder System: named in the summary without a submission number

## Most influential descendants
- K053338: Arthrex Titanium and Bio-Degradable (Polymer) Implants (2006), 0 descendants of its own

## Indications for use
The Cofield? Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are indicated for use as orthopaedic 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. The Cofield® Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are 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. The subject all poly glenoid components are intended for cemented fixation only and for single use only. The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all polyethylene glenoid components manufactured from UHMWPE material in the following product systems: o Cofield’ Total Shoulder System (all polyethylene glenoid components) e Neer II Total Shoulder System (all polyethylene glenoid components) e Neer III Total Shoulder System (all polyethylene glenoid components)

Source page: https://510kreport.com/device/K012788
Methodology: https://510kreport.com/methodology