510(k) · Cleared
ClearedHumelock II Reversible Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fx Solutions · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Nov 13, 2015 as substantially equivalent to K053274 (Zimmer GmbH, 2006) and 3 other predicates after a 261-day review. Its family tree reaches back 7 generations to 1991. 30 later devices descend from it.
- Decided
- Nov 13, 2015
- Review
- 261 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K911686 (1991). 50 ancestors in all, the oldest K800494 (1980). 30 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 3 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 1 generation backK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · Recalled
- This deviceK150488 Humelock II Reversible Shoulder SystemFx Solutions · 2015
- Descendant · cites it directly · 20 of its ownK163669 Humeris ShoulderFx Solutions · 2017
- Descendant · cites it directly · 17 of its ownK162455 Humelock Reversed ShoulderFx Solutions · 2017
- Descendant · 2 generations on · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK213117 FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK192206 32mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 2019 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K163669Humeris ShoulderFx Solutions · 2017 · cites it directly20descendants
- K162455Humelock Reversed ShoulderFx Solutions · 2017 · cites it directly17descendants
- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 2 generations on5descendants
- K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022 · 2 generations on4descendants
- K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 2019 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −3 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −1 | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | 3 |
| 0 (this device) | K150488 | Humelock II Reversible Shoulder System | Fx Solutions | 2015 | — |
| +1 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | — |
| +1 | K162455 | Humelock Reversed Shoulder | Fx Solutions | 2017 | — |
| +2 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +2 | K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2022 | — |
| +1 | K192206 | 32mm Glenosphere and Humeral Cup | Fx Shoulder USA, Inc. | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 PHX? 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 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 |
|---|---|---|---|
| * | K053274 | Anatomical Shoulder Inverse/ReverseSummary page 4…PHX Substantially Equivalent Devices: Zimmer Anatomical Shoulder Inverse/Reverse Total Shoulder Prosthesis, K053274 Fx Solutions Humelock II Cemented Shoulder System, K123814, K14… | 2006 |
| * | K123814 | Humelock II Cemented Shoulder SystemSummary page 4…Shoulder Prosthesis, K053274 Fx Solutions Humelock II Cemented Shoulder System, K123814, K140071 Fx Solutions Humelock II Cementless Shoulder System, K… | 2013 |
| * | K140071 | Humelock II Cemented Shoulder SystemSummary page 4…Shoulder Prosthesis, K053274 Fx Solutions Humelock II Cemented Shoulder System, K123814, K140071 Fx Solutions Humelock II Cementless Shoulder System, K130759 D… | 2014 |
| * | K130759 | Humelock II Cementless Shoulder SystemSummary page 4…K123814, K140071 Fx Solutions Humelock II Cementless Shoulder System, K130759 Device Description: Tornier Aequalis Reversed II Shoulder System, K132285 The Humelock II Reversible Shoulder is a total shoul… | 2013 |
What descends from it? (30)
See all 307 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163669 | Humeris Shoulder | 2017 | 20 |
| K162455 | Humelock Reversed Shoulder | 2017 | 17 |
| K192206 | 32mm Glenosphere and Humeral Cup | 2019 | 4 |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | 2020 | 3 |
| K192799 | Glenoid Baseplate with Screw | 2020 | 2 |
| K210790 | Lateralized and Augmented Baseplates | 2021 | 1 |
| K191146 | Humelock TiN Coated Glenosphere | 2020 | 0 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 16 of the 50 ancestors have a recall of any class.
- Of its descendants, K163669 (Fx Solutions, 2017) has gone furthest, with 20 descendants of its own.
- 12 other devices also cite its predicate K053274.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
The Humelock II Reversible Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150488: Humelock II Reversible 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/K150488
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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