# K003294: Biomet Lateral Troch Plate

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Nov 3, 2000 after 14 days
- Product code: JDW (Pin, Fixation, Threaded)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 1 cites it directly.
0 of 24 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
- K043593: Spine-Fix Biomimetic Bone Cement (2006), 22 descendants of its own
- K080873: Opacity + Bone Cement (2008), 20 descendants of its own
- K103433: F20 (2011), 18 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own

## Recalls of this device
- Jun 5, 2017 · Class II · Z-0296-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
- Jun 5, 2017 · Class II · Z-0297-2018: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.

Source page: https://510kreport.com/device/K003294
Methodology: https://510kreport.com/methodology