# K121624: Biomet Microfixation Neuro Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Microfixation
- Decided: Oct 12, 2012 after 133 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854886 (1986). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 2.
- K922741: Lorenz 1.0 MM System, Walter Lorenz Surgical, Inc. (1992) Summary page 2.
- K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System, Walter Lorenz Surgical, Inc. (1995) Summary page 2.

## Most influential descendants
- K141911: Optimus Neuro System (2015), 4 descendants of its own
- K183352: Optimus Neuro System (2019), 2 descendants of its own
- K190811: Optimus NEURO System - Sterile Kit (2019), 1 descendant of its own
- K212391: MCI-Neuro Fixation System (2022), 0 descendants of its own
- K210360: Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro Plating System-Packaging unit (NSP-001 and 10 models), Neuro Plating System-Sterile Kit (TCN-011 and 69 models), Neuro Plating System-Screws (N15A03 and 11 models) (2022), 0 descendants of its own

## Recalls of this device
- Aug 6, 2015 · Class II · Z-0136-2016: The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
- Aug 6, 2015 · Class II · Z-0137-2016: The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

## Indications for use
These devices are implantable bone plates and bone screws for neuro 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/K121624
Methodology: https://510kreport.com/methodology