510(k) · Cleared
Recalled · Class II · 2019Medacta Anatomic Shoulder Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Aug 16, 2017 as substantially equivalent to K083439 (Synthes (Usa), 2009) and 4 other predicates after a 141-day review. Its family tree reaches back 14 generations to 1991. 1 of the 113 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 16, 2017
- Review
- 141 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 14 generations to K911686 (1991). 104 ancestors in all, the oldest K790987 (1979). 8 later devices descend from it, 4 citing it directly. 1 of the 113 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- This deviceK170910 Medacta Anatomic Shoulder ProsthesisMedacta 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 · 1 of its ownK250644 MSS - Monobloc stemMedacta International S.A. · 2026 · Recalled
- Descendant · 2 generations on · 1 of its ownK241944 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2025
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- This deviceK170910 Medacta Anatomic Shoulder ProsthesisMedacta International S.A. · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations back · 2008
Most influential descendants
Showing 5 of 8 · 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
- K250644MSS - Monobloc stemMedacta International S.A. · 2026 · cites it directly1descendant
- K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −7 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −6 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −5 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −4 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −2 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −1 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| 0 (this device) | K170910 | Medacta Anatomic Shoulder Prosthesis | 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 | K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026 | 1 |
| +2 | K241944 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 9 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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.
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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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 |
|---|---|---|---|
| * | K083439 | Synthes Epoca Shoulder Prosthesis SystemSummary page 4…II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: x Synthes Epoca Shoulder Prosthesis System, K083439, Synthes (USA) Additional Predicates: x Depuy Global Unite Shoulder System, K101996, Depuy (Ireland) x Global… | 2009 |
| * | K101996 | Depuy Global Unite Shoulder SystemSummary page 4…Primary Predicate: x Synthes Epoca Shoulder Prosthesis System, K083439, Synthes (USA) Additional Predicates: x Depuy Global Unite Shoulder System, K101996, Depuy (Ireland) x Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head,… | 2010 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 4…y Global Unite Shoulder System, K101996, Depuy (Ireland) x Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, K992065, Depuy Orthopaedics, Inc. x Aequalis™ Ascend™ Flex Shoulder System, K122698, Tornier SAS x Aequalis Universal S… | 1999 |
| * | K122698 | Aequalis Ascend Flex Shoulder SystemSummary page 4…Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, K992065, Depuy Orthopaedics, Inc. x Aequalis™ Ascend™ Flex Shoulder System, K122698, Tornier SAS x Aequalis Universal Shoulder Glenoid, K994393, Tornier, S.A.… | 2013 |
| * | K994393 | Aequalis Universal Shoulder GlenoidSummary page 4…Eccentric Head, K992065, Depuy Orthopaedics, Inc. x Aequalis™ Ascend™ Flex Shoulder System, K122698, Tornier SAS x Aequalis Universal Shoulder Glenoid, K994393, Tornier, S.A. . 3DJHRI Medac… | 2000 |
| † | K170452 | Medacta Shoulder System | 2017 |
| † | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | 2010 |
| † | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | 2006 |
| † | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot | 2008 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2019 | Class II | Z-0775-2020 | Device Design | Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis. |
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 26 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 26 of the 104 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191433 (Implantcast GmbH, 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K083439.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
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 component is intended for cemented application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170910: Medacta Anatomic Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170910
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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