510(k) · Cleared
Recalled · 2008Total and Hemi Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dvo Extremity Solutions, LLC · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Dec 6, 2006 as substantially equivalent to K905786 (Depuy, Inc., 1991) and 2 other predicates after a 240-day review. Its family tree reaches back 3 generations to 1991. 194 later devices descend from it. It has been recalled 13 times.
- Decided
- Dec 6, 2006
- Review
- 240 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 13
- Predicates
- 3
Its longest line of descent runs back 3 generations to K911686 (1991). 7 ancestors in all, the oldest K905786 (1991). 194 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 2 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 1 generation backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- This deviceK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006
- Descendant · cites it directly · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
- Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 4 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- Descendant · cites it directly · 71 of its ownK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
Showing 5 of 194 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 194 · See all- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · cites it directly110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
- K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on97descendants
- K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 4 generations on96descendants
- K103007Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010 · cites it directly71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −2 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| 0 (this device) | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | — |
| +1 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +4 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| +1 | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 8 | 0 |
| 2018 | 11 | 0 |
| 2019 | 16 | 0 |
| 2020 | 15 | 0 |
| 2021 | 17 | 0 |
| 2022 | 19 | 0 |
| 2023 | 15 | 0 |
| 2024 | 16 | 0 |
| 2025 | 19 | 0 |
| 2026 | 20 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K905786 | Global Total ShoulderSummary page 1…R 888.3690, Class KL 87 HSD PREDICATE DEVICES: The DePuy Global shoulder system cleared in: * Total Shoulder, K905786, K(914000 * Advantage Shoulder Humeral Stem and Eccentric Head, K992065 DEVICE DESCRIPTIO… | 1991 |
| * | K914000 | Global (TM) Total Shoulder W/Dupont Enhanced UhmwpeSummary page 1…Class KL 87 HSD PREDICATE DEVICES: The DePuy Global shoulder system cleared in: * Total Shoulder, K905786, K(914000 * Advantage Shoulder Humeral Stem and Eccentric Head, K992065 DEVICE DESCRIPTION: This s… | 1991 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 1…: * Total Shoulder, K905786, K(914000 * Advantage Shoulder Humeral Stem and Eccentric Head, K992065 DEVICE DESCRIPTION: This sterile modular total and helmi shoulder system is comprised of a humeral stem, two styles of humneral… | 1999 |
What descends from it? (194)
See all 1946 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102924 | Aequalis Ascend Modular Anatomic Shoulder System | 2011 | 110 |
| K103007 | Affiniti Total and Hemi-Shoulder System | 2010 | 71 |
| K111902 | Aequalis Shoulder System | 2011 | 49 |
| K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C… | 2011 | 43 |
| K081707 | Aequalis Shoulder Fracture and Shoulder Systems | 2008 | 25 |
| K073331 | Dvo Extended Articulation Humeral Heads | 2008 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2008 | Not classified | Z-0818-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0819-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0822-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0823-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0824-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0825-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0827-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0820-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0821-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0826-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0828-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0829-2009 | Labeling Change Control | 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 AFFINITI Stems. |
| Oct 20, 2008 | Not classified | Z-0830-2009 | Labeling Change Control | 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 AFFINITI Stems. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K102924 (Tornier, Inc., 2011) has gone furthest, with 110 descendants of its own.
- 2 other devices also cite its predicate K905786.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (138 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060988: Total and Hemi Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060988
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026