510(k) · Cleared
ClearedArthrex Eclipse Shoulder Prosthesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · QHQ Total Shoulder Arthroplasty System
Cleared on Jul 26, 2019 as substantially equivalent to K071032 (Arthrex, Inc., 2007) and 2 other predicates after a 249-day review. Its family tree reaches back 7 generations to 1991. 8 later devices descend from it.
- Decided
- Jul 26, 2019
- Review
- 249 days
- Class
- Class II
- Product code
- QHQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K911686 (1991). 24 ancestors in all, the oldest K790987 (1979). 8 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- 3 generations backK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
- 2 generations backK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
- 1 generation backK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017 · Recalled
- This deviceK183194 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · cites it directly · 1 of its ownK201542 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK243248 Inhance Intact™Depuy Ireland UC · 2024
- Descendant · 2 generations on · 0 of its ownK230831 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE…Depuy Ireland UC · 2023
- Descendant · cites it directly · 0 of its ownK221758 SMR Stemless AnatomicLima Corporate S.P.A. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly3descendants
- K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2020 · cites it directly1descendant
- K243248Inhance Intact™Depuy Ireland UC · 2024 · 2 generations on0descendants
- K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC · 2023 · 2 generations on0descendants
- K221758SMR Stemless AnatomicLima Corporate S.P.A. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| −3 | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
| −2 | K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015 | — |
| −1 | K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017 | 3 |
| 0 (this device) | K183194 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2019 | — |
| +1 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +1 | K201542 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2020 | — |
| +2 | K243248 | Inhance Intact™ | Depuy Ireland UC | 2024 | — |
| +2 | K230831 | INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid | Depuy Ireland UC | 2023 | — |
| +1 | K221758 | SMR Stemless Anatomic | Lima Corporate S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 QHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K071032 | Arthrex Univers II Shoulder ProsthesisSummary page 4…duct Code PKC, QHQ Classification Name 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class II Primary Predicate Device K071032: Arthrex Univers II Shoulder Prosthesis K171858: Sidus Stem-Free Shoulder K143552: Simpliciti Shoulder System Reference Predicat… | 2007 |
| * | K171858 | Sidus Stem-Free ShoulderSummary page 4…88.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class II Primary Predicate Device K071032: Arthrex Univers II Shoulder Prosthesis K171858: Sidus Stem-Free Shoulder K143552: Simpliciti Shoulder System Reference Predicate Device K173388: Exactech Equinox Purpose of S… | 2017 |
| * | K143552 | Simpliciti Shoulder SystemSummary page 4…mer semi-constrained cemented prosthesis Regulatory Class II Primary Predicate Device K071032: Arthrex Univers II Shoulder Prosthesis K171858: Sidus Stem-Free Shoulder K143552: Simpliciti Shoulder System Reference Predicate Device K173388: Exactech Equinox Purpose of Submission This Traditional 510(k)… | 2015 |
| † | K173388 | Exactech Equinoxe Stemless Shoulder | 2018 |
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? (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 28 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K203108 (Ignite Orthopedics, LLC, 2021) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K071032.
How does its category compare?
All QHQ devicesQHQ Total Shoulder Arthroplasty System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QHQ
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QHQ
Too few QHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QHQ
No recall names QHQ since 2007.
Adverse event reports per year · QHQ
27in 2025
MAUDE reports naming product code QHQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.
The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183194: Arthrex Eclipse Shoulder Prosthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183194
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