# K121589: Biomet Microfixation Facial Plating System

- Pathway: 510(k) (Special)
- Applicant: Biomet Microfixation
- Decided: Sep 21, 2012 after 113 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
Longest line of descent: 5 generations back to K761228 (1976). 20 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System, Walter Lorenz Surgical, Inc. (1995) Summary page 3.
- K862534: Paulus Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 3.
- K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 3.
- K013954: Lorenz Self Drilling Screws, Walter Lorenz Surgical, Inc. (2002) Summary page 3.
- K922741: Lorenz 1.0 MM System, Walter Lorenz Surgical, Inc. (1992) Summary page 3.

## Most influential descendants
- K140037: Optimus CMF System (2015), 2 descendants of its own
- K253373: Southern Craniomaxillofacial (CMF) System (2025), 0 descendants of its own
- K182609: Delphos Implants Rigid Fixation System (2019), 0 descendants of its own
- K160363: Optimus CMF System (2016), 0 descendants of its own
- K132600: Facial Prebent Plating with Virtual Surgical Planning (2013), 0 descendants of its own

## Recalls of this device
- Jan 10, 2017 · Class II · Z-1220-2017: The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.

## Indications for use
These devices are implantable bone plates and bone screws for facial procedures including: 1. Fractures 2. Osteotomies 3. Reconstructive procedures 4. Revision procedures where other treatments or devices have failed

Source page: https://510kreport.com/device/K121589
Methodology: https://510kreport.com/methodology