510(k) Report

510(k) · Cleared

Cleared

System Iii Halo Ring

K930153510(k) TraditionalCleared Aug 6, 1993206-day reviewClass II21 CFR 888.3040

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

Jerome Medical · JEC Component, Traction, Invasive

Cleared on Aug 6, 1993 after a 206-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Aug 6, 1993
Review
206 days
Class
Class II
Product code
JEC
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared1999: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK930153 System Iii Halo RingJerome Medical · 1993
  2. Descendant · cites it directly · 1 of its ownK040363 Ceramic Tipped Skull PinThe Jerome Group, Inc. · 2004 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK090733 PMT Halo SystemPmt Corp. · 2009
  4. Descendant · cites it directly · 0 of its ownK980689 Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc. · 1999

Most influential descendants

Showing 3 of 3 · See all
  • K040363Ceramic Tipped Skull PinThe Jerome Group, Inc. · 2004 · cites it directly1descendant
  • K090733PMT Halo SystemPmt Corp. · 2009 · 2 generations on0descendants
  • K980689Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930153System Iii Halo RingJerome Medical1993—
+1K040363Ceramic Tipped Skull PinThe Jerome Group, Inc.20044
+2K090733PMT Halo SystemPmt Corp.2009—
+1K980689Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200410
200910
FIG. 1 — Lineage of K930153, 1993–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JEC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JEC device

  1. #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040363Ceramic Tipped Skull PinThe Jerome Group, Inc.20041
K980689Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc.19990

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?

  • Of its descendants, K040363 (The Jerome Group, Inc., 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JEC devices

JEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEC

1in 2021

2007: 12008: 12009: 12011: 12014: 12016: 12018: 22019: 12020: 12021: 1
2007high 2 (2018) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEC

Too few JEC 510(k)s in any year since 2007 to give a median.

Recalls per year · JEC

1in 2019

2008: 12016: 12018: 12019: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JEC

2in 2025

2007: 12008: 92009: 42010: 132011: 152012: 142013: 102014: 62015: 12016: 82017: 122018: 22019: 32020: 62021: 22022: 32023: 262024: 22025: 2
2007high 26 (2023) · low 1 (2007)2025

MAUDE reports naming product code JEC, 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—01
20081—19
20091—04
20100—013
20111—015
20120—014
20130—010
20141—06
20150—01
20161—18
20170—012
20182—12
20191—13
20201—06
20211—02
20220—03
20230—026
20240—02
20250—02
20260—0—

More from Jerome Medical

9 FDA decisions under this applicant name. See the company

  • K051918Resolve Open Back Halo RingsJerome Medical · 20057 recalls
  • K930021J TongsJerome Medical · 1995
  • K882877JMS Cervical Traction Device/Halo DeviceJerome Medical · 1988
  • K870053Torquedriver WrenchJerome Medical · 1987
  • K864969JMS Halo Application TrayJerome Medical · 1987

Recent decisions in JEC

The JEC category page

  • K203605SteriTrakArbutus Medical, Inc. · 2021
  • K193256Anjon Bremer Halo SystemAnjon Holdings, LLC · 20201 recall
  • K192465DigiFix Sterile KitVirak Orthopedics, LLC · 2019
  • K181192PIP FixHand Biomechanics Lab, Inc. · 2018
  • K171863Anjon Bremer Halo SystemAnjon Holdings, LLC · 2018

https://510kreport.com/device/K930153 · printed Nov 4, 2026

Cite this page

510(k) Report. “K930153: System Iii Halo Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930153

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026