510(k) · Cleared
Recalled · Class II · 2018Humelock Cemented Shoulder Prosthesis
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, 2011 as substantially equivalent to K992525 (Acu Med, Inc., 2000) and 1 other predicate after a 203-day review. Its family tree reaches back 3 generations to 1991. 34 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 9, 2011
- Review
- 203 days
- Class
- Class II
- Product code
- HSD
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K911686 (1991). 12 ancestors in all, the oldest K873073 (1987). 34 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 2 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 1 generation backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- This deviceK111097 Humelock Cemented Shoulder ProsthesisFx Solutions · 2011
- Descendant · cites it directly · 32 of its ownK123814 Humelock II Cemented Shoulder SystemFx Solutions · 2013
- Descendant · 2 generations on · 31 of its ownK140071 Humelock II Cemented Shoulder SystemFx Solutions · 2014
- Descendant · cites it directly · 31 of its ownK130759 Humelock II Cementless Shoulder SystemFx Solutions · 2013
- Descendant · 2 generations on · 30 of its ownK150488 Humelock II Reversible Shoulder SystemFx Solutions · 2015
- Descendant · 2 generations on · 20 of its ownK163669 Humeris ShoulderFx Solutions · 2017
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K123814Humelock II Cemented Shoulder SystemFx Solutions · 2013 · cites it directly32descendants
- K140071Humelock II Cemented Shoulder SystemFx Solutions · 2014 · 2 generations on31descendants
- K130759Humelock II Cementless Shoulder SystemFx Solutions · 2013 · cites it directly31descendants
- K150488Humelock II Reversible Shoulder SystemFx Solutions · 2015 · 2 generations on30descendants
- K163669Humeris ShoulderFx Solutions · 2017 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −2 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| 0 (this device) | K111097 | Humelock Cemented Shoulder Prosthesis | Fx Solutions | 2011 | — |
| +1 | K123814 | Humelock II Cemented Shoulder System | Fx Solutions | 2013 | — |
| +2 | K140071 | Humelock II Cemented Shoulder System | Fx Solutions | 2014 | — |
| +1 | K130759 | Humelock II Cementless Shoulder System | Fx Solutions | 2013 | — |
| +2 | K150488 | Humelock II Reversible Shoulder System | Fx Solutions | 2015 | — |
| +2 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | — |
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 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K992525 | Acumed Modular Shoulder SystemSummary page 1…der) metallic uncemented prosthesis, Class II Product Codes: HSD Substantially Equivalent Devices: K(992525 - Acumed Modular Shoulder System K(992065 - DePuy Global Advantage Shoulder Device Description… | 2000 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 1…II Product Codes: HSD Substantially Equivalent Devices: K(992525 - Acumed Modular Shoulder System K(992065 - DePuy Global Advantage Shoulder Device Description: The Humelock Cemented Shoulder Prosthesis is a hemi-shoulder prosthesis co… | 1999 |
What descends from it? (34)
See all 342 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 |
|---|---|---|---|---|
| Jun 4, 2018 | Class II | Z-2468-2018 | Package design/selection | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. |
| Jun 4, 2018 | Class II | Z-2469-2018 | Package design/selection | Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K123814 (Fx Solutions, 2013) has gone furthest, with 32 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. 2011, 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 Cemented Shoulder Prosthesis is indicated for use in 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 Humelock Cemented Shoulder Prosthesis is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111097: Humelock Cemented Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111097
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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