510(k) · Cleared
ClearedSynthes (Usa) Epoca Shoulder Prosthesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Nov 28, 2007 after a 76-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.
- Decided
- Nov 28, 2007
- Review
- 76 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 1 citing it directly.
- This deviceK072578 Synthes (Usa) Epoca Shoulder Prosthesis SystemSynthes (Usa) · 2007
- Descendant · cites it directly · 23 of its ownK091196 GRS Glenoid Resurfacing SystemArthrosurface, Inc. · 2009
- Descendant · 2 generations on · 13 of its ownK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · 3 generations on · 9 of its ownK212737 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
- Descendant · 2 generations on · 7 of its ownK152825 Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016
- Descendant · 3 generations on · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc. · 2009 · cites it directly23descendants
- K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · 2 generations on13descendants
- K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022 · 3 generations on9descendants
- K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC · 2016 · 2 generations on7descendants
- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072578 | Synthes (Usa) Epoca Shoulder Prosthesis System | Synthes (Usa) | 2007 | — |
| +1 | K091196 | GRS Glenoid Resurfacing System | Arthrosurface, Inc. | 2009 | — |
| +2 | K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +3 | K212737 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2022 | — |
| +2 | K152825 | Catalyst CSR Shoulder System | Catalyst Orthoscience, LLC | 2016 | — |
| +3 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 6 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (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 |
|---|---|---|---|
| * | — | ARGOMedical EPOCA Custom Offset Shoulder System Named without a submission number | |
| * | — | Tornier Aequalis Shoulder Fracture System Named without a submission number | |
| * | — | Aequalis Shoulder System Named without a submission number |
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091196 | GRS Glenoid Resurfacing System | 2009 | 23 |
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?
- Of its descendants, K091196 (Arthrosurface, Inc., 2009) has gone furthest, with 23 descendants of its own.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Synthes Epoca Shoulder Prosthesis System is intended for use as a hemi or total shoulder replacement. It is a single use device for reconstruction of the glenolmmeral joint in the presence of complex fractures (ie. 3 and 4 part), revision of failed fixation or arthroplasty, post-traumatic mal-union and disabled, painful shoulder joints resulting from various forms of arthropathy such as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avasoular necrosis and other pathologies where arthrodesis is not acceptable. The Press-fit Titanium Plasma Sprayed Humeral Stems are for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072578 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072578: Synthes (Usa) Epoca Shoulder Prosthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072578
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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