510(k) · Cleared
ClearedTitan Modular Total Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedic · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Apr 11, 2012 as substantially equivalent to K100448 (Ascension Orthopedics, Inc., 2010) after a 231-day review. Its family tree reaches back 4 generations to 1999. 3 later devices descend from it.
- Decided
- Apr 11, 2012
- Review
- 231 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K990137 (1999). 9 ancestors in all, the oldest K962082 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK990137 Anatomica Humeral Stem/Head ComponentsSulzer Orthopedics, Inc. · 1999
- 3 generations backK032126 Promos ShoulderPlus Orthopedics · 2004
- 2 generations backK063578 Promos Modular Shoulder SystemPlus Orthopedics AG · 2007 · Recalled
- 1 generation backK100448 Ascension Modular Total Shoulder SystemAscension Orthopedics, Inc. · 2010 · Recalled
- This deviceK112438 Titan Modular Total Shoulder SystemAscension Orthopedic · 2012
- Descendant · cites it directly · 2 of its ownK142413 TITAN Modular Total Shoulder SystemAscension Orthopedics · 2014
- Descendant · 2 generations on · 0 of its ownK254084 AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK213827 TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System…Smith & Nephew, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K142413TITAN Modular Total Shoulder SystemAscension Orthopedics · 2014 · cites it directly2descendants
- K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
- K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990137 | Anatomica Humeral Stem/Head Components | Sulzer Orthopedics, Inc. | 1999 | — |
| −3 | K032126 | Promos Shoulder | Plus Orthopedics | 2004 | — |
| −2 | K063578 | Promos Modular Shoulder System | Plus Orthopedics AG | 2007 | 4 |
| −1 | K100448 | Ascension Modular Total Shoulder System | Ascension Orthopedics, Inc. | 2010 | 1 |
| 0 (this device) | K112438 | Titan Modular Total Shoulder System | Ascension Orthopedic | 2012 | — |
| +1 | K142413 | TITAN Modular Total Shoulder System | Ascension Orthopedics | 2014 | — |
| +2 | K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026 | — |
| +1 | K213827 | TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN… | Smith & Nephew, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K100448 | Ascension Modular Total Shoulder SystemSummary page 1…joint humeral (hemi-shoulder) metallic uncemented prosthesis. Product Code HSD and KWS Panel Orthopedic Predicate Device K100448 - Ascension® TITANTM Total Shoulder System Device Description The TITAN Modular Total Shoulder System consists of a line of… | 2010 |
What descends from it? (3)
2 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 13 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K142413 (Ascension Orthopedics, 2014) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K100448.
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 Ascension TITAN Total Shoulder System is indicated for use as a hemi or total shoulder replacement for: Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory.…
Read the full statement (124 words)
The Ascension TITAN Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory.
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component).
Shoulder Hemiarthroplasty is also indicated for:
Ununited humeral head fractures.
Avascular necrosis of the humeral head.
Rotator cuff arthropathy.
Deformity and/or limited motion.
The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112438: Titan Modular 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/K112438
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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