510(k) · Cleared
ClearedMedacta Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Oct 5, 2017 as substantially equivalent to K062250 (DePuy Orthopaedics, Inc., 2007) and 4 other predicates after a 232-day review. Its family tree reaches back 10 generations to 1991. 12 later devices descend from it.
- Decided
- Oct 5, 2017
- Review
- 232 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K911686 (1991). 63 ancestors in all, the oldest K790987 (1979). 12 later devices descend from it, 8 citing it directly.
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations between
- 3 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 2 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 1 generation backK112144 Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder…Tornier · 2012
- This deviceK170452 Medacta Shoulder SystemMedacta International S.A. · 2017
- Descendant · cites it directly · 3 of its ownK191433 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
- Descendant · cites it directly · 3 of its ownK180089 Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A. · 2018
- Descendant · 2 generations on · 2 of its ownK231657 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2024
- Descendant · cites it directly · 2 of its ownK210207 Humeral Eccentric Reverse MetaphysisMedacta International S.A. · 2021
- Descendant · cites it directly · 1 of its ownK250644 MSS - Monobloc stemMedacta International S.A. · 2026 · Recalled
Show all 10 generations
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 8 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 7 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 6 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 4 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 3 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 2 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 1 generation backK112144 Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder…Tornier · 2012
- This deviceK170452 Medacta Shoulder SystemMedacta International S.A. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020 · cites it directly3descendants
- K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A. · 2018 · cites it directly3descendants
- K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2024 · 2 generations on2descendants
- K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A. · 2021 · cites it directly2descendants
- K250644MSS - Monobloc stemMedacta International S.A. · 2026 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −9 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −6 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −4 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −3 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −2 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −1 | K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis… | Tornier | 2012 | — |
| 0 (this device) | K170452 | Medacta Shoulder System | Medacta International S.A. | 2017 | — |
| +1 | K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020 | — |
| +1 | K180089 | Medacta Shoulder System Short Humeral Diaphysis | Medacta International S.A. | 2018 | — |
| +2 | K231657 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2024 | — |
| +1 | K210207 | Humeral Eccentric Reverse Metaphysis | Medacta International S.A. | 2021 | — |
| +1 | K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K062250 | Delta Xtend Reverse Shoulder SystemSummary page 4…sification 2 III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: Delta Xtend™ Reverse Shoulder System, K062250, DePuy Orthopaedics, Inc. Delta Xtend™ Reverse Shoulder Modular Stem, K071379, DePuy Orthopaedics, Inc. Additional Predic… | 2007 |
| * | K071379 | Delta Xtend Reverse Shoulder Modular StemSummary page 4…e following devices: Primary Predicate: Delta Xtend™ Reverse Shoulder System, K062250, DePuy Orthopaedics, Inc. Delta Xtend™ Reverse Shoulder Modular Stem, K071379, DePuy Orthopaedics, Inc. Additional Predicates Comprehensive® RS Shoulder System, K072804, Biomet Manufacturing Corporatio… | 2007 |
| * | K072804 | Comprehensive RS Shoulder SystemSummary page 4…uy Orthopaedics, Inc. Delta Xtend™ Reverse Shoulder Modular Stem, K071379, DePuy Orthopaedics, Inc. Additional Predicates Comprehensive® RS Shoulder System, K072804, Biomet Manufacturing Corporation Synthes Epoca Shoulder Prosthesis System, K083439, Synthes (USA) Aequalis Shoulder Fr… | 2007 |
| * | K083439 | Synthes Epoca Shoulder Prosthesis SystemSummary page 4…rthopaedics, Inc. Additional Predicates Comprehensive® RS Shoulder System, K072804, Biomet Manufacturing Corporation Synthes Epoca Shoulder Prosthesis System, K083439, Synthes (USA) Aequalis Shoulder Fracture System & Aequalis Shoulder System, Aequalis Reversed Shoulder Prosthesis, A… | 2009 |
| * | K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Summary page 4…Aequalis Shoulder System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis (also referred to as Aequalis Reversed II), K112144, Tornier Reference Device Versafitcup™ Double Mobility Highcross® HXUHMWPE Liners, K092265, Medacta International, S… | 2012 |
| † | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | 2010 |
What descends from it? (12)
See all 128 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191433 | AGILON® XO Shoulder Replacement System | 2020 | 3 |
| K180089 | Medacta Shoulder System Short Humeral Diaphysis | 2018 | 3 |
| K210207 | Humeral Eccentric Reverse Metaphysis | 2021 | 2 |
| K250644 | MSS - Monobloc stem | 2026 | 1 |
| K250338 | MSS - Humeral reverse liners extension | 2025 | 1 |
| K193175 | Lateralized Glenosphere | 2020 | 1 |
| K251737 | NextAR (TM) Shoulder Platform | 2025 | 0 |
| K203755 | Shoulder System - TiNbN Coating | 2021 | 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 1.3 years on median.
- 15 of the 63 ancestors have a recall of any class.
- Of its descendants, K191433 (Implantcast GmbH, 2020) has gone furthest, with 3 descendants of its own.
- 16 other devices also cite its predicate K062250.
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 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 and 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 for the device to offer full function in vivo.
The glenoid baseplate is intended for cementless application with the addition of screws for primary stability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170452: Medacta 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/K170452
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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