510(k) Report

510(k) · Cleared

Recalled · 2008

Jerome Glass Ring

K023959510(k) TraditionalCleared Feb 21, 200386-day reviewClass II21 CFR 882.5960Recalls 6

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

The Jerome Group, Inc. · HAX Tong, Skull For Traction

Cleared on Feb 21, 2003 as substantially equivalent to K822780 (Jerome Medical, 1982) after an 86-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it. It has been recalled 6 times.

Decided
Feb 21, 2003
Review
86 days
Class
Class II
Product code
HAX
Recalls
6
Predicates
1

Its longest line of descent runs back 1 generation to K822780 (1982). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant clearedK822780 · Cervical Brace · Jerome Medical · 1982 · recalled19801990200020102020
Descendants, by generation 1 generation forward: 1 descendant K822780 · Cervical Brace · Jerome Medical · 1982 · recalled0
  1. Root · 1 generation backK822780 Cervical BraceJerome Medical · 1982 · Recalled
  2. This deviceK023959 Jerome Glass RingThe Jerome Group, Inc. · 2003
  3. Descendant · cites it directly · 0 of its ownK051918 Resolve Open Back Halo RingsJerome Medical · 2005 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K051918Resolve Open Back Halo RingsJerome Medical · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K822780Cervical BraceJerome Medical19821
0 (this device)K023959Jerome Glass RingThe Jerome Group, Inc.2003—
+1K051918Resolve Open Back Halo RingsJerome Medical20057

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K023959, 1982–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K822780Cervical Brace
Summary page 1
…Classification Name: Tong, Skull for Traction, Sec. 882.5960, Neurological Devices, Class II, HAX Substantially Equivalent to: Generation 80 Halo Ring (K822780) also manufactured by Jerome Medical. Also similar to Halo Rings included in Lerman Low Profile Halo System, Bremer…
Jerome Medical19821

Also cleared against K822780: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051918Resolve Open Back Halo RingsJerome Medical20050

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 9, 2008Not classifiedZ-1509-2009Process change controlOssur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
Nov 9, 2008Not classifiedZ-1507-2009Process change controlOssur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
Nov 9, 2008Not classifiedZ-1508-2009Process change controlOssur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
Sep 26, 2008Not classifiedZ-0594-2009Packaging process controlOssur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
Sep 26, 2008Not classifiedZ-0595-2009Packaging process controlOssur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
Sep 26, 2008Not classifiedZ-0596-2009Packaging process controlOssur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K051918 (Jerome Medical, 2005) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K822780.

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

2007: 12009: 1
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

2008: 32014: 62018: 4
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

2008: 12010: 12011: 22015: 12016: 12017: 12020: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—31
20091—00
20100—01
20110—02
20120—00
20130—00
20140—60
20150—01
20160—01
20170—01
20180—40
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Jerome Glass Ring is intended for use with a Jerome Halo Vest to immobilize andor provide traction for a cervical spine injury.

Indications for use as stated in the FDA summary.

Also cleared against K822780

1 other device cites the same predicate.

  • K040363Ceramic Tipped Skull PinThe Jerome Group, Inc. · 20044 recalls

More from The Jerome Group, Inc.

2 FDA decisions under this applicant name. See the company

  • K040363Ceramic Tipped Skull PinThe Jerome Group, Inc. · 20044 recalls

Recent decisions in HAX

The HAX category page

  • K090733PMT Halo SystemPmt Corp. · 2009
  • K071173Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model JT-200D, JT-100DOssur Americans (Formerly the Jerome Group) · 2007
  • K051918Resolve Open Back Halo RingsJerome Medical · 20057 recalls
  • K003662Spine Works CollarSpine Works · 2001
  • K980689Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc. · 1999

https://510kreport.com/device/K023959 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023959: Jerome Glass Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023959

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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