510(k) · Cleared
ClearedTotal Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shoulder Innovations, LLC · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jan 24, 2011 as substantially equivalent to K982981 (Zimmer, Inc., 1998) after a 130-day review. Its family tree reaches back 2 generations to 1979. 18 later devices descend from it.
- Decided
- Jan 24, 2011
- Review
- 130 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K790987 (1979). 12 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK790987 Zimmer R Total Shoulder IIZimmer, Inc. · 1979
- 1 generation backK982981 New Zimmer Shoulder SystemZimmer, Inc. · 1998 · Recalled
- This deviceK102670 Total Shoulder SystemShoulder Innovations, LLC · 2011
- Descendant · cites it directly · 15 of its ownK111596 Total Shoulder SystemShoulder Innovations, LLC · 2011
- Descendant · 2 generations on · 13 of its ownK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 3 generations on · 9 of its ownK212737 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
- Descendant · 3 generations on · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 2 generations on · 2 of its ownK192365 Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc. · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K111596Total Shoulder SystemShoulder Innovations, LLC · 2011 · cites it directly15descendants
- K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · 2 generations on13descendants
- K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022 · 3 generations on9descendants
- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · 3 generations on3descendants
- K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790987 | Zimmer R Total Shoulder II | Zimmer, Inc. | 1979 | — |
| −1 | K982981 | New Zimmer Shoulder System | Zimmer, Inc. | 1998 | 1 |
| 0 (this device) | K102670 | Total Shoulder System | Shoulder Innovations, LLC | 2011 | — |
| +1 | K111596 | Total Shoulder System | Shoulder Innovations, LLC | 2011 | — |
| +2 | K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +3 | K212737 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2022 | — |
| +3 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +2 | K192365 | Shoulder Innovations Total Shoulder System | Shoulder Innovations, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K982981 | New Zimmer Shoulder SystemSummary page 1…(hemi-shoulder) metallic uncemented prosthesis. Product Code: HSID Substantially Equivalent Device: K982981:. Zimmer Bigliani/Flatow Total Shoulder System K noain Total Shoulder System -Updated 1118111 Page… | 1998 |
What descends from it? (18)
See all 183 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 32 years and passes through 2 companies; a new generation was cleared every 19.5 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K111596 (Shoulder Innovations, LLC, 2011) has gone furthest, with 15 descendants of its own.
- 6 other devices also cite its predicate K982981.
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. 2011, 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 Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; 2. united humeral head fractures of long duration; 3. irreducible 3- and 4-part proximal humeral fractures; 4. avascular necrosis of the humeral head. The assembled humeral component may be used…
Read the full statement (111 words)
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
2. united humeral head fractures of long duration;
3. irreducible 3- and 4-part proximal humeral fractures;
4. avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.
The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102670: Total 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/K102670
Report an extraction error
Are you the manufacturer?
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