510(k) · Cleared
ClearedArthrex Eclipse Titanium Humeral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Nov 20, 2020 as substantially equivalent to K201542 (Arthrex, Inc., 2020) after a 37-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Nov 20, 2020
- Review
- 37 days
- Class
- Class II
- Product code
- PKC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K911686 (1991). 26 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations between
- 3 generations backK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017 · Recalled
- 2 generations backK183194 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019
- 1 generation backK201542 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2020
- This deviceK203100 Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 6 generations backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- 5 generations backK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
- 4 generations backK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
- 3 generations backK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017 · Recalled
- 2 generations backK183194 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019
- 1 generation backK201542 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2020
- This deviceK203100 Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −8 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| −5 | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
| −4 | K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015 | — |
| −3 | K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017 | 3 |
| −2 | K183194 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2019 | — |
| −1 | K201542 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2020 | — |
| 0 (this device) | K203100 | Arthrex Eclipse Titanium Humeral Head | Arthrex, Inc. | 2020 | — |
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 |
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 PKC? 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 PKC device
- #1 K240716 AETOS Shoulder System Stemless Humeral…score 22.2 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K201542 | Arthrex Eclipse Shoulder Prosthesis SystemSummary page 4…PKC, QHQ Classification Name 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class Class II Predicate Device K201542: Arthrex Eclipse Shoulder Prosthesis Reference Device K182799: Arthrex Univers II Shoulder Prosthesis System: Titanium Humer… | 2020 |
| † | K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | 2019 |
| † | K183194 | Arthrex Eclipse Shoulder Prosthesis System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 26 ancestors have a recall of any class.
How does its category compare?
All PKC devicesPKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PKC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKC
167in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKC
86in 2025
MAUDE reports naming product code PKC, 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 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 1 | — | 1 | 8 |
| 2020 | 4 | 116 | 0 | 5 |
| 2021 | 2 | — | 0 | 14 |
| 2022 | 3 | 148 | 0 | 31 |
| 2023 | 1 | — | 0 | 46 |
| 2024 | 3 | 167 | 0 | 54 |
| 2025 | 1 | — | 0 | 86 |
| 2026 | 2 | — | 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.
The Arthrex Eclipse Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203100: Arthrex Eclipse Titanium Humeral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203100
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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