# K160085: Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Mar 8, 2016 after 53 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: 9 generations back to K911686 (1991). 41 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142403: Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System, Zimmer GmbH (2014) Summary page 5.
- K030259: Amatomical Shoulder with Removable Head, Centerplus Orthopedics, Inc. (2003) Summary page 6.
- K062029: Anatomical Shoulder Fracture System, Zimmer GmbH (2006) Summary page 6.

## Most influential descendants
- K170711: ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System (2017), 2 descendants of its own
- K193099: Anatomical Shoulder System (2020), 1 descendant of its own
- K260556: Veritas Shoulder System (2026), 0 descendants of its own

## Indications for use
Hemi or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System The Anatomical Shoulder Humeral Stems and Domelock System are indicated for • Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis. • Avascular necrosis. • Conditions consequent to earlier operations. • Omarthrosis. • Rheumatoid arthritis. • Revision of shoulder prosthesis. The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. Reverse Application of the Anatomical Shoulder System • The Anatomical Shoulder Inverse/Reverse System is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. • 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 Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation. Fracture Application of the Anatomical Shoulder Fracture System The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasty in treatment of the following: • Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment • Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment • Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment • Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus • Posttraumatic necrosis of the humeral head • Posttraumatic arthrosis after humeral head fracture The Humeral Fracture Stems are intended for either cemented or uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.

Source page: https://510kreport.com/device/K160085
Methodology: https://510kreport.com/methodology