510(k) · Cleared
Recalled · 2011Oxford Unicompartmental Knee Femoral Component
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 Jul 10, 2001 as substantially equivalent to K971938 (Biomet, Inc., 1997) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 10, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- HRY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K873601 (1988). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK873601 Agc Unicompartmental Knee ProsthesisBiomet, Inc. · 1988
- This deviceK011138 Oxford Unicompartmental Knee Femoral ComponentBiomet, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK122277 Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial…Biomet Manufacturing Corp · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK133940 Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings /…Biomet UK, Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK251618 MOTO Partial Knee System ExtensionMedacta International S.A. · 2025
Most influential descendants
Showing 3 of 3 · See all- K122277Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford…Biomet Manufacturing Corp · 2012 · cites it directly2descendants
- K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. · 2014 · 2 generations on1descendant
- K251618MOTO Partial Knee System ExtensionMedacta International S.A. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873601 | Agc Unicompartmental Knee Prosthesis | Biomet, Inc. | 1988 | — |
| 0 (this device) | K011138 | Oxford Unicompartmental Knee Femoral Component | Biomet, Inc. | 2001 | — |
| +1 | K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays… | Biomet Manufacturing Corp | 2012 | 30 |
| +2 | K133940 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays) | Biomet UK, Ltd. | 2014 | 4 |
| +3 | K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | K971938 | Repicci II Unicondylar KneeSummary page 1…otibial, Semi-constrained, Cemented, Metal/Polymer (21 CFR 888.3530) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Repicci™ Il Unicondylar Knee (K971938) and AGC® Unicompartmental Femoral Component (K873601) Device Description: The Oxford™ Unicompartmental Knee Femoral Component h… | 1997 |
| * | K873601 | Agc Unicompartmental Knee ProsthesisSummary page 1…CFR 888.3530) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Repicci™ Il Unicondylar Knee (K971938) and AGC® Unicompartmental Femoral Component (K873601) Device Description: The Oxford™ Unicompartmental Knee Femoral Component has a highly polished spherical articular surface. The… | 1988 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford… | 2012 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2011 | Not classified | Z-2698-2011 | Packaging | This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to
compartmental primary degenerative or post-traumatic degenerative disease, deformity or revision of
previous arthroplasty. The device is a single use, cemented implant
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011138: Oxford Unicompartmental Knee Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011138
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026