PMA · Approved
Recalled · Class II · 2016Oxford (TM) Meniscal Unicompartmental Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
Approved on Apr 21, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 1,147-day review. It has been recalled 22 times.
- Decided
- Apr 21, 2004
- Review
- 1,147 days
- Class
- Class III
- Product code
- NRA
- Recalls
- 22
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P010014 has 107 supplements since 2005: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2005 | 1 |
| 2006 | 5 |
| 2007 | 5 |
| 2008 | 6 |
| 2010 | 3 |
| 2011 | 6 |
| 2012 | 5 |
| 2013 | 8 |
| 2014 | 2 |
| 2015 | 4 |
| 2016 | 6 |
| 2017 | 8 |
| 2018 | 14 |
| 2019 | 12 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 | 8 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NRA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 5, 2016 | Class II | Z-1162-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1159-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1165-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1153-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1168-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1152-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1158-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1170-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1173-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1172-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1169-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1157-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1163-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1161-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1155-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1156-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1154-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1164-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1160-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| Jan 5, 2016 | Class II | Z-1171-2017 | Nonconforming Material/Component | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within… |
| 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. |
| Dec 19, 2008 | Not classified | Z-0962-2009 | Packaging process control | Packages labeled as "right" actually contain a "left" component. |
The 5 latest of 22 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NRA devicesNRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRA
Too few NRA 510(k)s in any year since 2007 to give a median.
Recalls per year · NRA
13in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NRA
440in 2025
MAUDE reports naming product code NRA, 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 | 5 | — | 0 | 2 |
| 2008 | 6 | — | 1 | 11 |
| 2009 | 0 | — | 0 | 46 |
| 2010 | 3 | — | 0 | 51 |
| 2011 | 6 | — | 13 | 143 |
| 2012 | 5 | — | 0 | 109 |
| 2013 | 8 | — | 0 | 158 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 4 | — | 0 | 590 |
| 2016 | 6 | — | 0 | 532 |
| 2017 | 8 | — | 0 | 676 |
| 2018 | 14 | — | 0 | 251 |
| 2019 | 12 | — | 0 | 518 |
| 2020 | 2 | — | 0 | 189 |
| 2021 | 1 | — | 0 | 234 |
| 2022 | 3 | — | 0 | 281 |
| 2023 | 1 | — | 0 | 274 |
| 2024 | 4 | — | 0 | 263 |
| 2025 | 3 | — | 0 | 440 |
| 2026 | 8 | — | 0 | — |
https://510kreport.com/device/P010014 · printed Nov 6, 2026
Cite this page
510(k) Report. “P010014: Oxford (TM) Meniscal Unicompartmental Knee System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P010014
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026