# K121714: Smith & Nephew, Inc. Shoulder System Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 7, 2012 after 88 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K911686 (1991). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 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.
- K855183: Cofield Shoulder System, Richards Medical Co., Inc. (1986) Summary page 1.
- K003566: Cofield Eccentric and Lateral Offset Humeral Heads, Smith & Nephew, Inc. (2001)
- K032126: Promos Shoulder, Plus Orthopedics (2004) Summary page 1.
- K063578: Promos Modular Shoulder System, Plus Orthopedics AG (2007) Summary page 1.
- K070565: Cofield Total Shoulder System, Smith & Nephew, Inc. (2007) Summary page 1.
- K081016: Smith & Nephew, Inc., Promos Reverse Shoulder System, Smith & Nephew, Inc. (2008)

## Indications for use
Smith &Nephew Cofield2 Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith &Nephew Cofield2 Shoulder Systems and their cleared Indications for Use. Indications for Shoulder Replacement 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. 4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activties. Total Shoulder Arthroolastv 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 Cofield2 Shoulder System includes humeral devices which are intended for use with or without bone cement and are single use devices. Cofield2 Shoulder System glenoid components are intended for use only with bone cement and are single use devices. Smith &Nephew Cofield Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith &Nephew Cofield Shoulder Systems and their cleared indications for Use. Indications for Shoulder Replacement Proximal Humeral Prosthesis 1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., the four-part injuries in the Neer classification, or head-spitting, 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. 4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities. Total Shoulder Arthroolastv 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 Cofield Shoulder System contains devices which are intended only for use with bone cement and are single use devices. Smith & Nephew Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Shoulder Systems and their cleared Indications for Use. The PROMOS Modular Shoulder System (Standard) is indicated for: * Advanced wear of the shoulder joint due to degenerative, post-traumatic or inflammatory arthritis * Avascular necrosis of the humeral head * Complex fractures of the proximal humerus * Functional impairment especially in the case of post-traumatic loss of the joint configuration The humeral stem and body components are intended for cementless use. The glenoid component is for use with bone cement only. The PROMOS Modular Shoulder System (Reverse) is indicated for the following: * The PROMOS Reverse Shoulder is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint * The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The humeral stem and body components are intended for cementless use. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Source page: https://510kreport.com/device/K121714
Methodology: https://510kreport.com/methodology