510(k) · Cleared
ClearedAgc Unicompartmental Knee Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Jan 20, 1988 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 20, 1988
- Review
- 149 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK873601 Agc Unicompartmental Knee ProsthesisBiomet, Inc. · 1988
- Descendant · cites it directly · 3 of its ownK011138 Oxford Unicompartmental Knee Femoral ComponentBiomet, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 2 of its ownK122277 Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial…Biomet Manufacturing Corp · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK133940 Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings /…Biomet UK, Ltd. · 2014 · Recalled
- Descendant · 4 generations on · 0 of its ownK251618 MOTO Partial Knee System ExtensionMedacta International S.A. · 2025
- Descendant · cites it directly · 0 of its ownK973672 Foundation Plasma Sprayed Metal-Backed PatellaEncore Orthopedics, Inc. · 1997
Most influential descendants
Showing 5 of 5 · See all- K011138Oxford Unicompartmental Knee Femoral ComponentBiomet, Inc. · 2001 · cites it directly3descendants
- K122277Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford…Biomet Manufacturing Corp · 2012 · 2 generations on2descendants
- K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. · 2014 · 3 generations on1descendant
- K251618MOTO Partial Knee System ExtensionMedacta International S.A. · 2025 · 4 generations on0descendants
- K973672Foundation Plasma Sprayed Metal-Backed PatellaEncore Orthopedics, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K873601 | Agc Unicompartmental Knee Prosthesis | Biomet, Inc. | 1988 | — |
| +1 | K011138 | Oxford Unicompartmental Knee Femoral Component | Biomet, Inc. | 2001 | 1 |
| +2 | K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays… | Biomet Manufacturing Corp | 2012 | 30 |
| +3 | K133940 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays) | Biomet UK, Ltd. | 2014 | 4 |
| +4 | K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025 | — |
| +1 | K973672 | Foundation Plasma Sprayed Metal-Backed Patella | Encore Orthopedics, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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 HRY? 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 HRY device
- #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
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? (5)
2 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?
- Of its descendants, K011138 (Biomet, Inc., 2001) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HRY devicesHRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRY
138in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRY
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRY
290in 2025
MAUDE reports naming product code HRY, 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 | 3 | 92 | 1 | 263 |
| 2008 | 3 | 138 | 1 | 285 |
| 2009 | 0 | — | 0 | 249 |
| 2010 | 1 | — | 0 | 180 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 1 | — | 0 | 137 |
| 2013 | 1 | — | 1 | 383 |
| 2014 | 1 | — | 0 | 305 |
| 2015 | 1 | — | 0 | 345 |
| 2016 | 1 | — | 1 | 343 |
| 2017 | 0 | — | 0 | 402 |
| 2018 | 0 | — | 0 | 613 |
| 2019 | 1 | — | 0 | 367 |
| 2020 | 1 | — | 1 | 1,054 |
| 2021 | 0 | — | 1 | 1,218 |
| 2022 | 0 | — | 3 | 840 |
| 2023 | 0 | — | 0 | 396 |
| 2024 | 0 | — | 0 | 430 |
| 2025 | 0 | — | 0 | 290 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K873601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K873601: Agc Unicompartmental Knee Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K873601
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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