510(k) Report

510(k) · Cleared

Cleared

Humeral Cup Stability & Humeral Cup 135/145o Stability

K193394510(k) TraditionalCleared Apr 29, 2020145-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fx Shoulder USA, Inc. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Apr 29, 2020 as substantially equivalent to K150488 (Fx Solutions, 2015) and 3 other predicates after a 145-day review. Its family tree reaches back 16 generations to 1991. 1 of the 126 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.

Decided
Apr 29, 2020
Review
145 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
4

Its longest line of descent runs back 16 generations to K911686 (1991). 122 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 1 citing it directly. 1 of the 126 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2015: 1 other ancestor2014: 1 other ancestor2013: 2 other ancestors2010: 1 other ancestor2008: 4 other ancestors2006: 10 other ancestors2012: 3 other ancestors2011: 3 other ancestors2009: 1 other ancestor2007: 5 other ancestors2005: 7 other ancestors2004: 5 other ancestors2003: 6 other ancestors2000: 8 other ancestors1999: 6 other ancestors1995: 4 other ancestors2001: 7 other ancestors1997: 2 other ancestors1996: 7 other ancestors1987: 5 other ancestors1980: 2 other ancestors1998: 3 other ancestors1993: 1 other ancestor1991: 2 other ancestors1988: 1 other ancestor2002: 1 other ancestor1994: 2 other ancestors1992: 2 other ancestors1979: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor2023: 1 descendant cleared2026: 1 descendant cleared2025: 1 descendant clearedReference device: K062250 · Delta Xtend Reverse Shoulder System · DePuy Orthopaedics, Inc. · 2007 · recalledK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) ×3: 3 generations cleared close together, K021478 (2003), K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) ×2: 2 generations cleared close together, K110599 (2011), K112615 (2011) K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK163669 · Humeris Shoulder · Fx Solutions · 2017K192206 · 32mm Glenosphere and Humeral Cup · Fx Shoulder USA, Inc. · 2019 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 21 other ancestors4 generations back: 24 other ancestors5 generations back: 16 other ancestors6 generations back: 13 other ancestors7 generations back: 14 other ancestors8 generations back: 3 other ancestors9 generations back: 6 other ancestors10 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants K192206 · 32mm Glenosphere and Humeral Cup · Fx Shoulder USA, Inc. · 2019 · recalledK163669 · Humeris Shoulder · Fx Solutions · 2017K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK112615 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−15−10−50
  1. Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 12 generations between
  3. 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  4. 2 generations backK163669 Humeris ShoulderFx Solutions · 2017
  5. 1 generation backK192206 32mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 2019 · Recalled
  6. This deviceK193394 Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc. · 2020
  7. Descendant · cites it directly · 2 of its ownK223833 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. · 2023 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK260583 Equinoxe® Shoulder SystemExactech, Inc. · 2026
  9. Descendant · 2 generations on · 0 of its ownK243448 Equinoxe® Shoulder SystemExactech, Inc. · 2025
Show all 16 generations
  1. Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 10 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. 2 generations backK163669 Humeris ShoulderFx Solutions · 2017
  16. 1 generation backK192206 32mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 2019 · Recalled
  17. This deviceK193394 Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc. · 2020

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder5 generations back · 2008

Most influential descendants

Showing 3 of 3 · See all
  • K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. · 2023 · cites it directly2descendants
  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026 · 2 generations on0descendants
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−15K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−14K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−13K021478Delta ShoulderDepuy, Inc.2003—
−12K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−11K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−10K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−9K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−8K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−7K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−6K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−5K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
−2K163669Humeris ShoulderFx Solutions2017—
−1K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.20191
0 (this device)K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.2020—
+1K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.20231
+2K260583Equinoxe® Shoulder SystemExactech, Inc.2026—
+2K243448Equinoxe® Shoulder SystemExactech, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198750
198810
198910
199120
199220
199310
199420
199540
199670
199720
199830
199960
200080
200170
200210
200360
200450
200570
2006100
200750
200840
200910
201010
201130
201230
201320
201410
201510
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202510
202610
FIG. 1 — Lineage of K193394, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

1 device in this family has a Class I recall. 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. #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K150488Humelock II Reversible Shoulder System
Summary page 5
…ially Equivalent Devices: Primary Predicate: Humelock II Reversible Shoulder System (K150488) Humelock Reversed Shoulder System (K162455) Hume…
Fx Solutions2015—
*K162455Humelock Reversed Shoulder
Summary page 5
…cate: Humelock II Reversible Shoulder System (K150488) Humelock Reversed Shoulder System (K162455) Humeris Shoulder System (K163669) 32mm Glenosphe…
Fx Solutions2017—
*K163669Humeris Shoulder
Summary page 5
…der System (K150488) Humelock Reversed Shoulder System (K162455) Humeris Shoulder System (K163669) 32mm Glenosphere and Cups (K192206) Reference D…
Fx Solutions2017—
*K19220632mm Glenosphere and Humeral Cup
Summary page 5
…ed Shoulder System (K162455) Humeris Shoulder System (K163669) 32mm Glenosphere and Cups (K192206) Reference Device: Delta Xtend™ Shoulder System…
Fx Shoulder USA, Inc.20191
†K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20078

Also cleared against K150488: 6 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.20232

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 29 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
  • 34 of the 122 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K223833 (Exactech, Inc., 2023) has gone furthest, with 2 descendants of its own.
  • 6 other devices also cite its predicate K150488.

How does its category compare?

All PHX devices

PHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · PHX

9in 2025

2007: 52008: 62009: 12010: 82011: 122012: 122013: 82014: 122015: 42016: 42017: 112018: 142019: 92020: 132021: 212022: 92023: 92024: 92025: 92026 (partial year): 18
2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007: 97 days median2008: 79 days median2010: 124 days median2011: 94 days median2012: 114 days median2013: 143 days median2014: 110 days median2015: 206 days median2016: 132 days median2017: 141 days median2018: 127 days median2019: 144 days median2020: 143 days median2021: 143 days median2022: 198 days median2023: 154 days median2024: 139 days median2025: 72 days median2026 (partial year): 130 days median
2007high 206 (2015) · low 72 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PHX

3in 2025

2015: 22018: 12019: 32020: 32021: 82023: 72024: 12025: 32026 (partial year): 7
2007high 8 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PHX

2,848in 2025

2015: 142016: 52017: 252018: 3232019: 5042020: 9862021: 1,4042022: 1,3422023: 1,4012024: 2,1422025: 2,848
2007high 2,848 (2025) · low 0 (2007)2025

MAUDE reports naming product code PHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200759700
200867900
20091—00
2010812400
2011129400
20121211400
2013814300
20141211000
20154206214
2016413205
201711141025
2018141271323
201991443504
2020131433986
20212114381,404
2022919801,342
2023915471,401
2024913912,142
202597232,848
2026181307—

What is it indicated for?

The Humelock II Reversible 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. The humeral stems are intended for cemented or cementless use. The…

Read the full statement (440 words)

The Humelock II Reversible 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.

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.

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 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 Prothesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prothesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotational 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.

In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

- A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;

- 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).

In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary 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 stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

Indications for use as stated in the FDA summary.

Also cleared against K150488

6 other devices cite the same predicate.

  • K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 2021
  • K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc. · 20201 recall
  • K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc. · 2020
  • K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 20191 recall
  • K163669Humeris ShoulderFx Solutions · 2017
  • K162455Humelock Reversed ShoulderFx Solutions · 2017

More from Fx Shoulder USA, Inc.

11 FDA decisions under this applicant name. See the company

  • K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 2024
  • K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc. · 2023
  • K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc. · 2022
  • K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022
  • K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 2021

Recent decisions in PHX

The PHX category page

  • K263421Veritas Shoulder Systemrestor3d, inc. · 2026
  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K260556Veritas Shoulder SystemRestor3D · 2026
  • K261683Augment Off-Axis Instrument SystemZimmer, Inc. · 2026
  • K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.) · 2026

https://510kreport.com/device/K193394 · printed Nov 5, 2026

Cite this page

510(k) Report. “K193394: Humeral Cup Stability & Humeral Cup 135/145o Stability.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193394

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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