510(k) · Cleared
Recalled · Class II · 2014Ascension Modular Total Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascension Orthopedics, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Aug 30, 2010 as substantially equivalent to K032126 (Plus Orthopedics, 2004) and 2 other predicates after a 194-day review. Its family tree reaches back 3 generations to 1999. 5 later devices descend from it. It has been recalled once.
- Decided
- Aug 30, 2010
- Review
- 194 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K990137 (1999). 8 ancestors in all, the oldest K962082 (1996). 5 later devices descend from it, 3 citing it directly.
- 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 deviceK100448 Ascension Modular Total Shoulder SystemAscension Orthopedics, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK112438 Titan Modular Total Shoulder SystemAscension Orthopedic · 2012
- Descendant · 2 generations on · 2 of its ownK142413 TITAN Modular Total Shoulder SystemAscension Orthopedics · 2014
- Descendant · cites it directly · 1 of its ownK152047 INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidAscension Orthopedics · 2015
- Descendant · 3 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 5 of 5 · See all- K112438Titan Modular Total Shoulder SystemAscension Orthopedic · 2012 · cites it directly3descendants
- K142413TITAN Modular Total Shoulder SystemAscension Orthopedics · 2014 · 2 generations on2descendants
- K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidAscension Orthopedics · 2015 · cites it directly1descendant
- K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026 · 3 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 |
|---|---|---|---|---|---|
| −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) | K100448 | Ascension Modular Total Shoulder System | Ascension Orthopedics, Inc. | 2010 | — |
| +1 | K112438 | Titan Modular Total Shoulder System | Ascension Orthopedic | 2012 | — |
| +2 | K142413 | TITAN Modular Total Shoulder System | Ascension Orthopedics | 2014 | — |
| +1 | K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid | Ascension Orthopedics | 2015 | — |
| +3 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (3)
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…semi- constrained cemented prosthesis PRODUCT CODE: HSD and KWS PANEL: Orthopedic PREDICATE DEVICES: K032126/K063578 - Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System K962082: Osteonics' All Polyethylene Glenoid Shoulder K… | 2004 |
| * | K063578 | Promos Modular Shoulder SystemSummary page 1…constrained cemented prosthesis PRODUCT CODE: HSD and KWS PANEL: Orthopedic PREDICATE DEVICES: K032126/K063578 - Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System K962082: Osteonics' All Polyethylene Glenoid Shoulder Keeled Co… | 2007 |
| * | K962082 | Osteonics All Polyethylene Glenoid Shoulder ComponentSummary page 1…HSD and KWS PANEL: Orthopedic PREDICATE DEVICES: K032126/K063578 - Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System K962082: Osteonics' All Polyethylene Glenoid Shoulder Keeled Components DEVICE DESCRIPTION: The Modular Total Shoulder System consists o… | 1996 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2014 | Class II | Z-0197-2015 | Nonconforming Material/Component | A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K112438 (Ascension Orthopedic, 2012) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K032126.
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 Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for: 1. 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…
Read the full statement (130 words)
The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
1. 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).
Shoulder Hemiarthroplasty is also indicated for:
1. Ununited humeral head fractures.
2. Avascular necrosis of the humeral head.
3. Rotator cuff arthropathy.
4. Deformity and/or limited motion.
The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100448: Ascension 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/K100448
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