510(k) Report

510(k) · Cleared

Cleared

MSS - Humeral reverse liners extension

K261016510(k) TraditionalCleared Jun 10, 202675-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

Medacta International, SA · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Jun 10, 2026 as substantially equivalent to K250644 (Medacta International S.A., 2026) and 1 other predicate after a 75-day review. Its family tree reaches back 18 generations to 1991. 1 of the 220 devices in its family, counting itself, has a Class I recall.

Decided
Jun 10, 2026
Review
75 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
2

Its longest line of descent runs back 18 generations to K911686 (1991). 219 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 220 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2025: 1 other ancestor2023: 1 other ancestor2022: 2 other ancestors2021: 2 other ancestors2018: 2 other ancestors2017: 2 other ancestors2013: 7 other ancestors2007: 8 other ancestors2020: 2 other ancestors2016: 3 other ancestors2014: 4 other ancestors2012: 9 other ancestors2011: 9 other ancestors2010: 5 other ancestors2009: 4 other ancestors2006: 14 other ancestors2000: 13 other ancestors2015: 1 other ancestor2008: 9 other ancestors2005: 10 other ancestors2004: 8 other ancestors2003: 9 other ancestors2002: 6 other ancestors2001: 7 other ancestors1999: 6 other ancestors1998: 7 other ancestors1997: 4 other ancestors1996: 8 other ancestors1995: 8 other ancestors1991: 3 other ancestors1994: 7 other ancestors1992: 5 other ancestors1988: 1 other ancestor1987: 5 other ancestors1980: 2 other ancestors1993: 3 other ancestors1989: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1981: 1 other ancestorK911686 · 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 · 2017K213117 · FX V135 Shoulder Prosthesis · Fx Shoulder USA, Inc. · 2022K223801 · FX V135(TM) Shoulder Prosthesis · Fx Shoulder USA, Inc. · 2023K250644 · MSS - Monobloc stem · Medacta International S.A. · 2026 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 8 other ancestors3 generations back: 20 other ancestors4 generations back: 53 other ancestors5 generations back: 41 other ancestors6 generations back: 25 other ancestors7 generations back: 16 other ancestors8 generations back: 19 other ancestors9 generations back: 5 other ancestors10 generations back: 3 other ancestors11 generations back: 7 other ancestors12 generations back: 3 other ancestors K250644 · MSS - Monobloc stem · Medacta International S.A. · 2026 · recalledK223801 · FX V135(TM) Shoulder Prosthesis · Fx Shoulder USA, Inc. · 2023K213117 · FX V135 Shoulder Prosthesis · Fx Shoulder USA, Inc. · 2022K163669 · 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 · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 14 generations between
  3. 3 generations backK213117 FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022
  4. 2 generations backK223801 FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc. · 2023
  5. 1 generation backK250644 MSS - Monobloc stemMedacta International S.A. · 2026 · Recalled
  6. This deviceK261016 MSS - Humeral reverse liners extensionMedacta International, SA · 2026
Show all 18 generations
  1. Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 17 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 16 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 15 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 14 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 13 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 12 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 11 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 10 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 9 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 8 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 7 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 6 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 5 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. 4 generations backK163669 Humeris ShoulderFx Solutions · 2017
  16. 3 generations backK213117 FX V135 Shoulder ProsthesisFx Shoulder USA, Inc. · 2022
  17. 2 generations backK223801 FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc. · 2023
  18. 1 generation backK250644 MSS - Monobloc stemMedacta International S.A. · 2026 · Recalled
  19. This deviceK261016 MSS - Humeral reverse liners extensionMedacta International, SA · 2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder4 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−17K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−16K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−15K021478Delta ShoulderDepuy, Inc.2003—
−14K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−13K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−12K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−11K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−10K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−9K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−8K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−7K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−6K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
−4K163669Humeris ShoulderFx Solutions2017—
−3K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.2022—
−2K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.2023—
−1K250644MSS - Monobloc stemMedacta International S.A.20261
0 (this device)K261016MSS - Humeral reverse liners extensionMedacta International, SA2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198110
198610
198750
198810
198910
199130
199250
199330
199470
199580
199680
199740
199870
199960
2000130
200170
200260
200390
200480
2005100
2006140
200780
200890
200940
201050
201190
201290
201370
201440
201510
201630
201720
201820
202020
202120
202220
202310
202510
FIG. 1 — Lineage of K261016, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K250644MSS - Monobloc stem
Summary page 5
…II III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: x MSS - Monobloc stem, K250644, Medacta International SA Additional Predicate devices x MSS - Humeral reverse liners extension, K250338, Medac…
Medacta International S.A.20261
*K250338MSS - Humeral reverse liners extension
Summary page 5
…redicate device: x MSS - Monobloc stem, K250644, Medacta International SA Additional Predicate devices x MSS - Humeral reverse liners extension, K250338, Medacta International SA IV. Device Description The MSS - Humeral reverse liners extension is a Medacta Shoulder System line…
Medacta International S.A.2025—

What descends from it?

No later submission names this one as a predicate yet.

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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 35 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
  • 62 of the 219 ancestors have a recall of any class; 1 has a Class I recall.

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. 2026, 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 Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is…

Read the full statement (235 words)

The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint.

The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The humeral stems are intended for cemented or cementless use.

The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral short stem is intended for cementless use. The Glenoid Reconstruction System baseplate is intended for cementless application with the addition of polyaxial screws for primary stability. A Glenoid Reconstruction System central screw can be used to provide additional fixation.

Indications for use as stated in the FDA summary.

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/K261016 · printed Nov 6, 2026

Cite this page

510(k) Report. “K261016: MSS - Humeral reverse liners extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261016

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026