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 Jul 28, 2014 as substantially equivalent to K123814 (Fx Solutions, 2013) and 1 other predicate after a 196-day review. Its family tree reaches back 5 generations to 1991. 31 later devices descend from it.
- Decided
- Jul 28, 2014
- Review
- 196 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K911686 (1991). 20 ancestors in all, the oldest K873073 (1987). 31 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 4 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 3 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 2 generations backK060874 Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc. · 2006
- 1 generation backK123814 Humelock II Cemented Shoulder SystemFx Solutions · 2013
- This deviceK140071 Humelock II Cemented Shoulder SystemFx Solutions · 2014
- Descendant · cites it directly · 30 of its ownK150488 Humelock II Reversible Shoulder SystemFx Solutions · 2015
- Descendant · 2 generations on · 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
- Descendant · 3 generations on · 4 of its ownK213117 FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K150488Humelock II Reversible Shoulder SystemFx Solutions · 2015 · cites it directly30descendants
- K163669Humeris ShoulderFx Solutions · 2017 · 2 generations on20descendants
- K162455Humelock Reversed ShoulderFx Solutions · 2017 · 2 generations on17descendants
- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 3 generations on5descendants
- K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −4 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K060874 | Depuy Global AP Shoulder System | DePuy Orthopaedics, Inc. | 2006 | — |
| −1 | K123814 | Humelock II Cemented Shoulder System | Fx Solutions | 2013 | — |
| 0 (this device) | K140071 | Humelock II Cemented Shoulder System | Fx Solutions | 2014 | — |
| +1 | K150488 | Humelock II Reversible Shoulder System | Fx Solutions | 2015 | — |
| +2 | 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 | — |
| +3 | K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2022 | — |
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 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K123814 | Humelock II Cemented Shoulder SystemSummary page 1…r) metallic uncemented prosthesis, Class 11 Product Codes: KWIT, HSD Substantially Equivalent Devices: K1 23814 - Humelock 11 Cemented Shoulder Sy'stem K994392 -Tornier Aequalis Shoulder Fracture System Dev… | 2013 |
| * | K994392 | Aequalis Shoulder Fracture SystemSummary page 1…uct Codes: KWIT, HSD Substantially Equivalent Devices: K1 23814 - Humelock 11 Cemented Shoulder Sy'stem K994392 -Tornier Aequalis Shoulder Fracture System Device Description: The Humelock 11 Cemented Shoulder System is a total and hemni-sh… | 2000 |
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150488 | Humelock II Reversible Shoulder System | 2015 | 30 |
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 23 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K150488 (Fx Solutions, 2015) has gone furthest, with 30 descendants of its own.
- 3 other devices also cite its predicate K123814.
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. 2014, 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 II Cemented Shoulder System 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 osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arthrodesis 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 Humelock II Cemented Shoulder System are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140071: Humelock II Cemented Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140071
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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