# K010212: Offset Tibial Tray

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Feb 14, 2001 after 22 days
- Product code: MBV (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093293: Vanguard 360 Revision Knee System (2010), 21 descendants of its own
- K122183: Augment and Screw, Psa Type (2013), 10 descendants of its own
- K121149: Vanguard SSK 360 Revision Knee System (2012), 7 descendants of its own
- K142933: Biomet Tibial trays (2014), 6 descendants of its own
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own

## Recalls of this device
- May 18, 2018 · Class II · Z-2177-2018: One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component a
- Nov 15, 2012 · Class II · Z-0533-2013: Biomet investigation identified that the square end of the offset tibial tray adaptor locking insert is oversized and may not engage insert tool screwdriver. This could cause a possible delay in surge
- Feb 13, 2009 · Not classified · Z-1061-2009: A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.

Source page: https://510kreport.com/device/K010212
Methodology: https://510kreport.com/methodology