510(k) · Cleared
ClearedHumelock II Cementless Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fx Solutions · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Nov 9, 2013 as substantially equivalent to K992525 (Acu Med, Inc., 2000) and 3 other predicates after a 234-day review. Its family tree reaches back 5 generations to 1994. 31 later devices descend from it.
- Decided
- Nov 9, 2013
- Review
- 234 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K943462 (1994). 36 ancestors in all, the oldest K873073 (1987). 31 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 4 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 3 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 2 generations backK052472 Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005
- 1 generation backK103835 Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model…Howmedica Osteonics Corp. · 2011 · Recalled
- This deviceK130759 Humelock II Cementless Shoulder SystemFx Solutions · 2013
- 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 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −4 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −3 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −2 | K052472 | Depuy Global Shoulder Crosslink Glenoid | DePuy Orthopaedics, Inc. | 2005 | — |
| −1 | K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX… | Howmedica Osteonics Corp. | 2011 | 1 |
| 0 (this device) | K130759 | Humelock II Cementless Shoulder System | Fx Solutions | 2013 | — |
| +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 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 3 | 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 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? (4)
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 |
|---|---|---|---|
| * | K992525 | Acumed Modular Shoulder SystemSummary page 1…der) metallic uncemented prosthesis, Class 11 Product Codes: FHSD SubstantiL-fly Equivalent Devices: K992525 - Acurned Modular Shoulder System K<111097 - Ex Solutions H-urnilock Cemented Shoulder… | 2000 |
| * | K111097 | Humelock Cemented Shoulder ProsthesisSummary page 1…Product Codes: FHSD SubstantiL-fly Equivalent Devices: K992525 - Acurned Modular Shoulder System K<111097 - Ex Solutions H-urnilock Cemented Shoulder P'rosthiesis K… | 2011 |
| * | K060874 | Depuy Global AP Shoulder SystemSummary page 1…K<111097 - Ex Solutions H-urnilock Cemented Shoulder P'rosthiesis K060874 - De~uy Global AP Shoulder System K<103835 - f-lowmnedica Osteonics ReUnion TSA System Device… | 2006 |
| * | K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Summary page 1…ed Shoulder P'rosthiesis K060874 - De~uy Global AP Shoulder System K<103835 - f-lowmnedica Osteonics ReUnion TSA System Device Description: '[he 1lUmelock 11 Cernentless Shoulder System is a bemi-shoulde… | 2011 |
What descends from it? (31)
See all 312 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 19 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 13 of the 36 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 K992525.
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. 2013, 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 Humelock II Cementless Shoulder System is indicated for use in hemi shoulder replacement for fractures of the proximal humerus. The Humelock II Cementless Humeral Stem is intended for use with two cortical screws and is intended for cementless use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130759: Humelock II Cementless 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/K130759
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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