510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Ceramic Tipped Skull Pin

K040363510(k) TraditionalCleared Apr 12, 200459-day reviewClass II21 CFR 888.3030Recalls 4

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. · LYT Fixation Accessory

Cleared on Apr 12, 2004 as substantially equivalent to K822780 (Jerome Medical, 1982) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1982. 1 later device descends from it. It has been recalled 4 times.

Decided
Apr 12, 2004
Review
59 days
Class
Class II
Product code
LYT
Recalls
4
Predicates
2

Its longest line of descent runs back 1 generation to K822780 (1982). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor2009: 1 descendant clearedK822780 · Cervical Brace · Jerome Medical · 1982 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant K822780 · Cervical Brace · Jerome Medical · 1982 · recalled0
  1. Root · 1 generation backK822780 Cervical BraceJerome Medical · 1982 · Recalled
  2. This deviceK040363 Ceramic Tipped Skull PinThe Jerome Group, Inc. · 2004
  3. Descendant · cites it directly · 0 of its ownK090733 PMT Halo SystemPmt Corp. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K090733PMT Halo SystemPmt Corp. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K822780Cervical BraceJerome Medical19821
0 (this device)K040363Ceramic Tipped Skull PinThe Jerome Group, Inc.2004—
+1K090733PMT Halo SystemPmt Corp.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K040363, 1982–2009Source: 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 LYT? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K822780Cervical Brace
Summary page 1
…mponent metallic bone fixation appliances and accessories Sec. 888.3030 Class II LXT Substantially Equivalent to: Jerome Traction Skull Pins (included in K822780 and K930153) also manufactured by Jerome Medical. Also similar to Traction Skull Pins included in Bremer Halo Sys…
Jerome Medical19821
*K930153System Iii Halo Ring
Summary page 1
…e fixation appliances and accessories Sec. 888.3030 Class II LXT Substantially Equivalent to: Jerome Traction Skull Pins (included in K822780 and K930153) also manufactured by Jerome Medical. Also similar to Traction Skull Pins included in Bremer Halo System Cervical Tractio…
Jerome Medical1993—

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
K090733PMT Halo SystemPmt Corp.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 21, 2018Class IIZ-0998-2019Labeling designHalo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line…
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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K090733 (Pmt Corp., 2009) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K822780.

How does its category compare?

All LYT devices

LYT Fixation Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYT

FDA has decided no LYT device since 2007.

Median 510(k) review, days · LYT

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

Recalls per year · LYT

1in 2018

2008: 32018: 1
2007high 3 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LYT

1in 2025

2008: 12009: 52010: 22011: 12012: 132013: 22014: 32021: 12025: 1
2007high 13 (2012) · low 0 (2007)2025

MAUDE reports naming product code LYT, 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
20070—00
20080—31
20090—05
20100—02
20110—01
20120—013
20130—02
20140—03
20150—00
20160—00
20170—00
20180—10
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—01
20260—0—

What is it indicated for?

The Ceramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System. are designed to hold the skull firmly inplace relative to the btrso so cervical vertebrae are immobilized following surgery or injury.

Indications for use as stated in the FDA summary.

Also cleared against K822780

1 other device cites the same predicate.

  • K023959Jerome Glass RingThe Jerome Group, Inc. · 20036 recalls

More from The Jerome Group, Inc.

2 FDA decisions under this applicant name. See the company

  • K023959Jerome Glass RingThe Jerome Group, Inc. · 20036 recalls

Recent decisions in LYT

The LYT category page

  • K983685Bone BandChapel and Assoc. · 1998
  • K980594Osteonics FX-Cablelok Grip ComponentsOsteonics Corp. · 1998
  • K914812K-Cap-E, SterileWestcon Orthopedics, Inc. · 1992
  • K912762K-Cap-I, SterileWestcon Orthopedics, Inc. · 1991
  • K902053K-Cap-I Orthopedic Fixation Wire CapWestcon Orthopedics, Inc. · 1990

https://510kreport.com/device/K040363 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040363: Ceramic Tipped Skull Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040363

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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