# K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Jan 21, 1986 after 46 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
241 later devices descend from it; 10 cite it directly.
0 of 242 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
- K963741: Leibinger Luhr Small Craniomaxillofacial Bone Screws (1997), 188 descendants of its own
- K963739: Leibinger - Luhr Small Orthopedic Bone Screws (1997), 144 descendants of its own
- K970912: Leibinger Self-Drilling Screw (1997), 143 descendants of its own
- K974785: Auto-Drive Bone Screw (1998), 141 descendants of its own
- K013954: Lorenz Self Drilling Screws (2002), 117 descendants of its own

## Recalls of this device
- Aug 31, 2010 · Not classified · Z-0108-2011: Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).

Source page: https://510kreport.com/device/K854886
Methodology: https://510kreport.com/methodology