510(k) · Cleared

Cleared

Friddle Halo System, Friddle Mri Halo System

K980689510(k) TraditionalCleared Feb 18, 1999360-day reviewClass II21 CFR 882.5960

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Friddle'S Orthopedic Appliances, Inc. · HAX Tong, Skull For Traction

Cleared on Feb 18, 1999 as substantially equivalent to K822885 (Orthopedic Systems, Inc., 1982) and 4 other predicates after a 360-day review. Its family tree reaches back 1 generation to 1982.

Decided: Feb 18, 1999
Review: 360 days
Class: Class II
Product code: HAX
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K822885 (1982). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK822885 Halo Traction Cervical ImmobilizationOrthopedic Systems, Inc. · 1982
This deviceK980689 Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K822885	Halo Traction Cervical Immobilization	Orthopedic Systems, Inc.	1982	—
0 (this device)	K980689	Friddle Halo System, Friddle Mri Halo System	Friddle'S Orthopedic Appliances, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0
1993	2	0
1995	1	0

FIG. 1 — Lineage of K980689, 1982–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K822885	Halo Traction Cervical Immobilization Summary page 1 …m is substantially equivalent to the classified device and to other devices cleared for marketing by the 510(k) process such as the "Halo Traction Cervical Immobilizer" (K822885), "Bremer Imaging Tongs, MRI model" (K924506), "Ace Cervical Traction Halozs, Tongs, and Pins," (K954069), the "Halo Ring" (K9301…	Orthopedic Systems, Inc.	1982	—
*	K924606	Bremer Imaging Tongs-Mri Model Our OCR of the scanned summary read K924506, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bremer Imaging Tongs, MRI model”.	Bremer Medical, Inc.	1993	—
*	K954069	Ace Cervical Traction Halozs, Tongs & Pins Summary page 1 …510(k) process such as the "Halo Traction Cervical Immobilizer" (K822885), "Bremer Imaging Tongs, MRI model" (K924506), "Ace Cervical Traction Halozs, Tongs, and Pins," (K954069), the "Halo Ring" (K930153), and is most similar to the PMT Halo/Orthopedic Jacket System (K834047). Several of these products ar…	Ace Medical Co.	1995	—
*	K930153	System Iii Halo Ring Summary page 1 …"Halo Traction Cervical Immobilizer" (K822885), "Bremer Imaging Tongs, MRI model" (K924506), "Ace Cervical Traction Halozs, Tongs, and Pins," (K954069), the "Halo Ring" (K930153), and is most similar to the PMT Halo/Orthopedic Jacket System (K834047). Several of these products are listed below for convenie…	Jerome Medical	1993	—
*	K834047	PMT-Halo/Orthopedic Jacket System Summary page 1 …RI model" (K924506), "Ace Cervical Traction Halozs, Tongs, and Pins," (K954069), the "Halo Ring" (K930153), and is most similar to the PMT Halo/Orthopedic Jacket System (K834047). Several of these products are listed below for convenient reference. The "510(k) Substantial Equivalence Decision-making Proces…	Progress Mankind Technology	1984	—

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?

None of the 5 ancestors has a recall.

How does its category compare?

All HAX devices

HAX Tong, Skull For Traction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAX

1in 2009

2007high 1 (2007) · low 0 (2008)2026

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

2007high 6 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HAX

1in 2020

2007high 2 (2011) · low 0 (2007)2025

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?

This device is designed to provide traction and/or to immobilize a patient with a cervical spine injury or after surgery.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980689 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980689: Friddle Halo System, Friddle Mri Halo System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980689

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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