# K071147: Nexa Orthopedics Total Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Jul 20, 2007 after 87 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K800494 (1980). 41 ancestors in all.
120 later devices descend from it; 2 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 1.
- K992899: Bio-Modular Shoulder Offset Humeral Heads, Biomet, Inc. (1999) Summary page 1.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 1.
- K032507: Interlok Bio-Modular Humeral Stems, Biomet, Inc. (2003) Summary page 1.
- K063081: Aequalis Shoulder System, Tornier (2006) Summary page 1.
- K061862: Axiom Orthopaedics Shoulder Resurfacing System, Axiom Orthopaedics, Inc. (2006) Summary page 1.

## Most influential descendants
- K102924: Aequalis Ascend Modular Anatomic Shoulder System (2011), 110 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K113413: Ascend Shoulder System (2012), 105 descendants of its own
- K120794: Ascend Shoulder System (2012), 98 descendants of its own
- K121493: Ascend Shoulder System (2012), 97 descendants of its own

## Indications for use
The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only inpatients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following: * Rheumatoid arthritis with pain * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humeral head * Traumatic arthritis * Revision of other devices if sufficient bone stock remains All components are single use. The humeral stem is intended for cemented or cementless use while the all polyethylene glenoid is intended for cemented use only.

Source page: https://510kreport.com/device/K071147
Methodology: https://510kreport.com/methodology