510(k) · Cleared
ClearedPMT Halo System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pmt Corp. · HAX Tong, Skull For Traction
Cleared on Jul 28, 2009 as substantially equivalent to K834047 (Progress Mankind Technology, 1984) and 1 other predicate after a 131-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Jul 28, 2009
- Review
- 131 days
- Class
- Class II
- Product code
- HAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K822780 (1982). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K822780 | Cervical Brace | Jerome Medical | 1982 | 1 |
| −1 | K040363 | Ceramic Tipped Skull Pin | The Jerome Group, Inc. | 2004 | 4 |
| 0 (this device) | K090733 | PMT Halo System | Pmt Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K834047 | PMT-Halo/Orthopedic Jacket SystemSummary page 1…em Classification Name: HAX, Skull Tongs for Traction 882.5960 Common/Usual Name: Halo Predicate Device PMT Halo System (834047) Jerome Medical Skull Pins (040363) Indication for Use The PMT Halo System with Open Back Carbon Graphite and Titanium Skull P… | 1984 |
| * | K040363 | Ceramic Tipped Skull PinSummary page 1…HAX, Skull Tongs for Traction 882.5960 Common/Usual Name: Halo Predicate Device PMT Halo System (834047) Jerome Medical Skull Pins (040363) Indication for Use The PMT Halo System with Open Back Carbon Graphite and Titanium Skull Pins and the PMT Halo System with Cl… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 21.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K834047.
How does its category compare?
All HAX devicesHAX Tong, Skull For Traction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HAX
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · HAX
Too few HAX 510(k)s in any year since 2007 to give a median.
Recalls per year · HAX
4in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAX
1in 2020
MAUDE reports naming product code HAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 3 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 6 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 4 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090733: PMT Halo System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090733
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026