# K070565: Cofield Total Shoulder System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: May 18, 2007 after 79 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K800494 (1980). 20 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 47 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.
- K011099: Global FX Porous-Coated Humeral Stem, DePuy Orthopaedics, Inc. (2001)
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K093430: Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid Contd. (2010), 24 descendants of its own
- K103419: Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM (2010), 22 descendants of its own
- K111379: Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large / Extra-Large, Left / Right (2011), 21 descendants of its own
- K121220: Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right (2012), 20 descendants of its own
- K150583: Aequalis PerFORM+ Shoulder System (2015), 16 descendants of its own

## Indications for use
The Cofield2 Total Shoulder System is indicated 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, 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. 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 Severe destruction of the glenohumerat articular surfaces with intractable chronic pain in rheumatoid arthritis, juvenile 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 Cofield2 Total Shoulder System includes porous coated devices which are intended for use without bone cement, and are single use devices.

Source page: https://510kreport.com/device/K070565
Methodology: https://510kreport.com/methodology