510(k) · Cleared
ClearedHumelock II Cemented Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fx Solutions · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Aug 13, 2013 as substantially equivalent to K111097 (Fx Solutions, 2011) and 1 other predicate after a 244-day review. Its family tree reaches back 4 generations to 1991. 32 later devices descend from it.
- Decided
- Aug 13, 2013
- Review
- 244 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K911686 (1991). 18 ancestors in all, the oldest K873073 (1987). 32 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 3 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 2 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 1 generation backK060874 Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc. · 2006
- This deviceK123814 Humelock II Cemented Shoulder SystemFx Solutions · 2013
- Descendant · cites it directly · 31 of its ownK140071 Humelock II Cemented Shoulder SystemFx Solutions · 2014
- Descendant · cites it directly · 30 of its ownK150488 Humelock II Reversible Shoulder SystemFx Solutions · 2015
- Descendant · cites it directly · 20 of its ownK163669 Humeris ShoulderFx Solutions · 2017
- Descendant · 2 generations on · 17 of its ownK162455 Humelock Reversed ShoulderFx Solutions · 2017
- Descendant · 3 generations on · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K140071Humelock II Cemented Shoulder SystemFx Solutions · 2014 · cites it directly31descendants
- K150488Humelock II Reversible Shoulder SystemFx Solutions · 2015 · cites it directly30descendants
- K163669Humeris ShoulderFx Solutions · 2017 · cites it directly20descendants
- K162455Humelock Reversed ShoulderFx Solutions · 2017 · 2 generations on17descendants
- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −3 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K060874 | Depuy Global AP Shoulder System | DePuy Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K123814 | Humelock II Cemented Shoulder System | Fx Solutions | 2013 | — |
| +1 | K140071 | Humelock II Cemented Shoulder System | Fx Solutions | 2014 | — |
| +1 | K150488 | Humelock II Reversible Shoulder System | Fx Solutions | 2015 | — |
| +1 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | — |
| +2 | K162455 | Humelock Reversed Shoulder | Fx Solutions | 2017 | — |
| +3 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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 KWT? 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 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 |
|---|---|---|---|
| * | K111097 | Humelock Cemented Shoulder ProsthesisSummary page 1…) metallic uncemented prosthesis, Class 11 Product Codes: KWXT, -ISD Substantially Equivalent Devices: K111097 - Fx Solutions 1-urneloek Cemented Shoulder Prosthesis K060874… | 2011 |
| * | K060874 | Depuy Global AP Shoulder SystemSummary page 1…tially Equivalent Devices: K111097 - Fx Solutions 1-urneloek Cemented Shoulder Prosthesis K060874 - DePuv Global AP Shoulder System Device Description: Tlhe Humeclock If Cemented Shoulder System is a total and hemi-shoulder p… | 2006 |
What descends from it? (32)
See all 324 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 22 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K140071 (Fx Solutions, 2014) has gone furthest, with 31 descendants of its own.
- 1 other device also cites its predicate K111097.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Humelock 11 Cemented Shoulder Systemn is indicated for use in total and hemi-shoulder replacement to treat:
1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osreoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arrhroclesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
The humeral stem and glenoid components of the Humnelock IT Cemnented Sholder System are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123814: Humelock II Cemented 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/K123814
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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