510(k) · Cleared
ClearedHemi-Shoulder Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on May 22, 1995 after a 102-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it.
- Decided
- May 22, 1995
- Review
- 102 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 0
20 later devices descend from it, 1 citing it directly.
- This deviceK950594 Hemi-Shoulder ProsthesisEncore Orthopedics, Inc. · 1995
- Descendant · cites it directly · 19 of its ownK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
- Descendant · 2 generations on · 18 of its ownK172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer…Encore Medical L.P. · 2017 · Recalled
- Descendant · 2 generations on · 15 of its ownK190290 AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019
- Descendant · 2 generations on · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK211991 Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K141990Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · cites it directly19descendants
- K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P. · 2017 · 2 generations on18descendants
- K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P. · 2019 · 2 generations on15descendants
- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 2 generations on5descendants
- K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 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) | K950594 | Hemi-Shoulder Prosthesis | Encore Orthopedics, Inc. | 1995 | — |
| +1 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
| +2 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate… | Encore Medical L.P. | 2017 | 3 |
| +2 | K190290 | AltiVate Reverse Humeral Stem, 48mm | Encore Medical L.P. | 2019 | — |
| +2 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +3 | K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141990 | Encore Humeral Shoulder Stem | 2014 | 19 |
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, K141990 (Encore Medical L.P., 2014) has gone furthest, with 19 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.
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 | — |
https://510kreport.com/device/K950594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950594: Hemi-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/K950594
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026