510(k) · Cleared
Recalled · Class II · 2022Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet UK, Ltd. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Mar 28, 2014 as substantially equivalent to K122277 (Biomet Manufacturing Corp, 2012) after a 95-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Mar 28, 2014
- Review
- 95 days
- Class
- Class II
- Product code
- HRY
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971938 (1997). 7 ancestors in all, the oldest K873601 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- 3 generations backK021621 Fixed Bearing Uni ComponentBiomet, Inc. · 2002
- 2 generations backK042093 Vanguard M Series Unicondylar Tibial BearingsBiomet, Inc. · 2004 · Recalled
- 1 generation backK122277 Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial…Biomet Manufacturing Corp · 2012 · Recalled
- This deviceK133940 Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings /…Biomet UK, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK251618 MOTO Partial Knee System ExtensionMedacta International S.A. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251618MOTO Partial Knee System ExtensionMedacta International S.A. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971938 | Repicci II Unicondylar Knee | Biomet, Inc. | 1997 | 1 |
| −3 | K021621 | Fixed Bearing Uni Component | Biomet, Inc. | 2002 | — |
| −2 | K042093 | Vanguard M Series Unicondylar Tibial Bearings | Biomet, Inc. | 2004 | 2 |
| −1 | K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays… | Biomet Manufacturing Corp | 2012 | 30 |
| 0 (this device) | K133940 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays) | Biomet UK, Ltd. | 2014 | — |
| +1 | K251618 | MOTO Partial Knee System Extension | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays a-F) Ixford…Summary page 1…panel Orthopedic Regulation 21 CER §888.3530 Product Code(s) HRY Legally marketed K122277 OxfbrdFixed Lateral Bearing Partial Knee device(s) to which Replacement equivalence isclaimed Reason for 510(k… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251618 | MOTO Partial Knee System Extension | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2022 | Class II | Z-1018-2023 | Package design/selection | Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the… |
| Nov 25, 2020 | Class II | Z-0624-2021 | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
| Apr 17, 2020 | Class II | Z-2148-2020 | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit |
| Dec 6, 2016 | Class II | Z-0956-2017 | Employee error | Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right was opened it actually contained a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K251618 (Medacta International S.A., 2025) has gone furthest, with 0 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. 2014, this device’s year, is highlighted.
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 knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment.
The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.
The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133940 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133940: Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133940
Report an extraction error
Are you the manufacturer?
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