# K090733: PMT Halo System

- Pathway: 510(k) (Traditional)
- Applicant: Pmt Corp.
- Decided: Jul 28, 2009 after 131 days
- Product code: HAX (Tong, Skull For Traction)
- Device class: 2
- Regulation: 21 CFR 882.5960
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822780 (1982). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834047: PMT-Halo/Orthopedic Jacket System, Progress Mankind Technology (1984) Summary page 1.
- K040363: Ceramic Tipped Skull Pin, The Jerome Group, Inc. (2004) Summary page 1.

## Indications for use
The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Closed Back Carbon Graphite and Titanium Skull Pins provide. cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries. The PMT Halo system is MR Conditional and may be used safely in an MRI under the following conditions: * Static magnetic field of 1.5T and 3T only * Maximum spatial gradient magnetic field of 720 Gauss/cm or less * Normal operating mode with a maximum MR system reported, whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning (per pulse sequence).

Source page: https://510kreport.com/device/K090733
Methodology: https://510kreport.com/methodology