510(k) · Cleared
ClearedAffiniti Total and Hemi-Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Nov 9, 2010 as substantially equivalent to K060988 (Dvo Extremity Solutions, LLC, 2006) after a 28-day review. Its family tree reaches back 4 generations to 1991. 71 later devices descend from it.
- Decided
- Nov 9, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911686 (1991). 8 ancestors in all, the oldest K905786 (1991). 71 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 3 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 2 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 1 generation backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- This deviceK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
- Descendant · cites it directly · 49 of its ownK111902 Aequalis Shoulder SystemTornier · 2011
- Descendant · 2 generations on · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · 3 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- Descendant · cites it directly · 24 of its ownK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
- Descendant · 4 generations on · 23 of its ownK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K111902Aequalis Shoulder SystemTornier · 2011 · cites it directly49descendants
- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · 2 generations on31descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 3 generations on25descendants
- K143552Simpliciti Shoulder SystemTornier, Inc. · 2015 · cites it directly24descendants
- K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −3 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| 0 (this device) | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
| +1 | K111902 | Aequalis Shoulder System | Tornier | 2011 | — |
| +2 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +3 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| +1 | K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015 | — |
| +4 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 8 | 0 |
| 2025 | 10 | 0 |
| 2026 | 9 | 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? (1)
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 |
|---|---|---|---|
| * | K060988 | Total and Hemi Shoulder SystemSummary page 2…Pagel1 of 3 ID5b -~ 5) Equivalent/IPredicate device * Tomier DVO Total and Hemi Shoulder System: K060988 Note: o The Tomier DVO Total and Hemi Shoulder System (K060988) is presently named Affiniti Total… | 2006 |
What descends from it? (71)
See all 712 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K111902 (Tornier, 2011) has gone furthest, with 49 descendants of its own.
- 5 other devices also cite its predicate K060988.
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. 2010, this device’s year, is highlighted.
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 Affiniti Total and Hemi-Shoulder System are 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…
Read the full statement (142 words)
The Affiniti Total and Hemi-Shoulder System are 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).
The Affiniti Hemi-Shoulder System is also indicated for:
1. Ununited humeral head fractures.
2. Avascular necrosis of the humeral head.
3. Rotator cuff tear arthropathy.
Notes:
* Glenoid components are labeled "for cemented use only" and are indicated only for use with bone cement.
* Humeral stems are indicated for press-fit un-cemented 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/K103007 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103007: Affiniti 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/K103007
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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