510(k) · Cleared
ClearedPromos Modular Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jan 5, 2012 as substantially equivalent to K063578 (Plus Orthopedics AG, 2007) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jan 5, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K990137 (1999). 8 ancestors in all, the oldest K955767 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK990137 Anatomica Humeral Stem/Head ComponentsSulzer Orthopedics, Inc. · 1999
- 2 generations backK032126 Promos ShoulderPlus Orthopedics · 2004
- 1 generation backK063578 Promos Modular Shoulder SystemPlus Orthopedics AG · 2007 · Recalled
- This deviceK113012 Promos Modular Shoulder SystemSmith & Nephew, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990137 | Anatomica Humeral Stem/Head Components | Sulzer Orthopedics, Inc. | 1999 | — |
| −2 | K032126 | Promos Shoulder | Plus Orthopedics | 2004 | — |
| −1 | K063578 | Promos Modular Shoulder System | Plus Orthopedics AG | 2007 | 4 |
| 0 (this device) | K113012 | Promos Modular Shoulder System | Smith & Nephew, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K063578 | Promos Modular Shoulder SystemSummary page 1…Orthopaedics/87 Product Code: -HSD, KWVS Device Description The Promos Modular Shoulder System, as cleared via premarket notification K063578, consists of two primary components: the glenoid component and the modular humeral component. The modular humeral component consi… | 2007 |
| * | K955767 | Cofied Modular Shoulder SystemSummary page 2…m inclination Sets cleared via premarket notification K063578. They are also similar in intended use to the Cofield 2 Shoulder System cleared via premnarket notification K955767. Table 1: Substantially equivalent predicate devices _____… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 5 other devices also cite its predicate K063578.
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. 2012, 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 Promos Modular Shoulder System is indicated for:
* Advanced degeneration of the shoulder joint as a result of degenerative, post-traumatic or inflammatory arthritis
* Avasctilar necrosis of the humeral head
* Complex fractures of the proximal humerus
* Functional impairment especially in the case of post-traumatic loss of the joint configuration
The humeral component is intended for cemented or cementless use. The glenoid component is for use with bone cement. only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113012: Promos Modular 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/K113012
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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