510(k) · Cleared
ClearedHumelock Reversed Shoulder
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 Jan 17, 2017 as substantially equivalent to K150488 (Fx Solutions, 2015) and 3 other predicates after a 137-day review. Its family tree reaches back 11 generations to 1991. 17 later devices descend from it.
- Decided
- Jan 17, 2017
- Review
- 137 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K911686 (1991). 73 ancestors in all, the oldest K800494 (1980). 17 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations between
- 3 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 2 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 1 generation backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- This deviceK162455 Humelock Reversed ShoulderFx Solutions · 2017
- Descendant · cites it directly · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK192206 32mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK211991 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK193394 Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK223833 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. · 2023 · Recalled
Show all 11 generations
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 9 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 8 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 7 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 4 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 3 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 2 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 1 generation backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- This deviceK162455 Humelock Reversed ShoulderFx Solutions · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · cites it directly5descendants
- K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 2019 · cites it directly4descendants
- K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 2 generations on3descendants
- K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc. · 2020 · cites it directly3descendants
- K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −10 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −7 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −4 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −3 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −2 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −1 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| 0 (this device) | K162455 | Humelock Reversed Shoulder | Fx Solutions | 2017 | — |
| +1 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +1 | K192206 | 32mm Glenosphere and Humeral Cup | Fx Shoulder USA, Inc. | 2019 | 1 |
| +2 | K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +1 | K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | Fx Shoulder USA, Inc. | 2020 | — |
| +2 | K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Exactech, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K150488 | Humelock II Reversible Shoulder SystemSummary page 4…cemented prosthesis. Product Codes: 87/PHX, 87/HSD Substantially Equivalent Devices: Fx Solutions Humelock II Reversible Shoulder, K150488 Tornier Aequalis Reversed Shoulder Prosthesis, K100142, K082120… | 2015 |
| * | K100142 | Aequalis Reversed Shoulder ProsthesisSummary page 4…Fx Solutions Humelock II Reversible Shoulder, K150488 Tornier Aequalis Reversed Shoulder Prosthesis, K100142, K082120, K030941 Device Description: The Humelock Reversed Shoulder is a total shoulder prosthesis designed for use in patients… | 2010 |
| * | K082120 | Aequalis Reversed Fracture Shoulder ProthesisSummary page 4…utions Humelock II Reversible Shoulder, K150488 Tornier Aequalis Reversed Shoulder Prosthesis, K100142, K082120, K030941 Device Description: The Humelock Reversed Shoulder is a total shoulder prosthesis designed for use in patients with a n… | 2008 |
| * | K030941 | Aequalis Reversed Shoulder ProsthesisSummary page 4…melock II Reversible Shoulder, K150488 Tornier Aequalis Reversed Shoulder Prosthesis, K100142, K082120, K030941 Device Description: The Humelock Reversed Shoulder is a total shoulder prosthesis designed for use in patients with a non-functi… | 2004 |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | 2021 | 5 |
| 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 |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | 2024 | 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 26 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 73 ancestors have a recall of any class.
- Of its descendants, K202611 (Catalyst Orthoscience, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K150488.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Reversed Shoulder 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. During primary or revision surgery, if the glenoid bone stock appears to be…
Read the full statement (176 words)
The Humelock Reversed Shoulder 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.
During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.
The humeral stem of the Humelock Reversed Cemented Shoulder Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prosthesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotation spoiler can be used with either the cementless or the cemented stems.
The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162455: Humelock Reversed Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162455
Report an extraction error
Are you the manufacturer?
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