# K060988: Total and Hemi Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Dvo Extremity Solutions, LLC
- Decided: Dec 6, 2006 after 240 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K911686 (1991). 7 ancestors in all.
194 later devices descend from it; 6 cite it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905786: Global Total Shoulder, Depuy, Inc. (1991) Summary page 1.
- K914000: Global (TM) Total Shoulder W/Dupont Enhanced Uhmwpe, Depuy, Inc. (1991) Summary page 1.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) 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
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own
- K103007: Affiniti Total and Hemi-Shoulder System (2010), 71 descendants of its own

## Recalls of this device
- Oct 20, 2008 · Not classified · Z-0818-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0819-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0822-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0823-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0824-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0825-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0827-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0820-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0821-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0826-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0828-2009: Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AF
- Oct 20, 2008 · Not classified · Z-0829-2009: Tornier, Medical has received on report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of A
- Oct 20, 2008 · Not classified · Z-0830-2009: Tornier, Medical has received on report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of A

## Indications for use
The DVO TM Total and Hemi Shoulder System is indicated for: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 2. Fracture/dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory; 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component). Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head. 3. Rotator cuff tear arthropathy. Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are indicated for press-fit uncemented use or for use with bone cement. This is a single use device.

Source page: https://510kreport.com/device/K060988
Methodology: https://510kreport.com/methodology