510(k) · Cleared
Recalled · 2010Promos Modular Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics AG · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Mar 2, 2007 as substantially equivalent to K032126 (Plus Orthopedics, 2004) after a 92-day review. Its family tree reaches back 2 generations to 1999. 67 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 2, 2007
- Review
- 92 days
- Class
- Class II
- Product code
- HSD
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990137 (1999). 6 ancestors in all. 67 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK990137 Anatomica Humeral Stem/Head ComponentsSulzer Orthopedics, Inc. · 1999
- 1 generation backK032126 Promos ShoulderPlus Orthopedics · 2004
- This deviceK063578 Promos Modular Shoulder SystemPlus Orthopedics AG · 2007
- Descendant · cites it directly · 52 of its ownK081016 Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 44 of its ownK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · Recalled
- Descendant · cites it directly · 38 of its ownK101263 Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR…Lima-Lto S.P.A. · 2011
- Descendant · cites it directly · 37 of its ownK100858 Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder…Lima-Lto S.P.A. · 2010 · Recalled
- Descendant · 2 generations on · 34 of its ownK110847 SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. · 2008 · cites it directly52descendants
- K110598SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · 2 generations on44descendants
- K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A. · 2011 · cites it directly38descendants
- K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A. · 2010 · cites it directly37descendants
- K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990137 | Anatomica Humeral Stem/Head Components | Sulzer Orthopedics, Inc. | 1999 | — |
| −1 | K032126 | Promos Shoulder | Plus Orthopedics | 2004 | — |
| 0 (this device) | K063578 | Promos Modular Shoulder System | Plus Orthopedics AG | 2007 | — |
| +1 | K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder System | Smith & Nephew, Inc. | 2008 | 2 |
| +2 | K110598 | SMR Reverse Shoulder System | Lima Corporate S.P.A. | 2011 | 1 |
| +1 | K101263 | Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder… | Lima-Lto S.P.A. | 2011 | — |
| +1 | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System -… | Lima-Lto S.P.A. | 2010 | 2 |
| +2 | K110847 | SMR Shoulder System - Cta Humeral Heads | Lima Corporate S.P.A. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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 |
|---|---|---|---|
| * | K032126 | Promos ShoulderSummary page 1…emi-constrained, metal/polymer cemented E.3 Substantial Equivalence Claimed to Predicate Device 3.1 PROMOS® Modular Shoulder System, K032126 Traditional 510(k) - PROMOS® Modular Shoulder System Company Confidential November 27, 2006… | 2004 |
What descends from it? (67)
See all 676 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder System | 2008 | 52 |
| K101263 | Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -… | 2011 | 38 |
| K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral… | 2010 | 37 |
| K100448 | Ascension Modular Total Shoulder System | 2010 | 5 |
| K121714 | Smith & Nephew, Inc. Shoulder System Instruments | 2012 | 0 |
| K113012 | Promos Modular Shoulder System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2010 | Not classified | Z-1239-2010 | Device Design | Firm received complaints of Inclination Set Screws fracturing. |
| Jan 14, 2010 | Not classified | Z-1241-2010 | Device Design | Firm received complaints of Inclination Set Screws fracturing. |
| Jan 14, 2010 | Not classified | Z-1240-2010 | Device Design | Firm received complaints of Inclination Set Screws fracturing. |
| Jan 14, 2010 | Not classified | Z-1242-2010 | Device Design | Firm received complaints of Inclination Set Screws fracturing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K081016 (Smith & Nephew, Inc., 2008) has gone furthest, with 52 descendants of its own.
- 4 other devices also cite its predicate K032126.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
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
* Avascular 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/K063578 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063578: Promos Modular Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063578
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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