# K122049: Neuropro Low Profile Cranial Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Kinamed, Inc.
- Decided: Apr 5, 2013 after 267 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K761228 (1976). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964362: Kinamed Profix System, Kinamed, Inc. (1997) Summary page 1.
- K982927: Quick Tap Self Drilling Screw, Kinamed, Inc. (1998) Summary page 1.
- K911936: Osteomed SBF System (SBF), Osteomed Corp. (1991) Summary page 1.
- K953385: Lorenz 1.0MM, 1.5MM, 2.0MM System, Walter Lorenz Surgical, Inc. (1995) Summary page 1.
- K974785: Auto-Drive Bone Screw, Osteomed Corp. (1998) Summary page 1.

## Indications for use
The NeuroPro® Low Profile Cranial Plating System Family is intended for: 1. Internal fixation of fractures and osteotomies of the cranial skeleton. 2. Internal fixation of cranial bone flap osteotomies. 3. Reconstruction of bony defects and deficits in the cranial skeleton. The NeuroPro® Low Profile Cranial Plating System is not indicated for use in the spine or high load bearing applications.

Source page: https://510kreport.com/device/K122049
Methodology: https://510kreport.com/methodology