510(k) Report

510(k) · Cleared

Cleared

Horizon Orthopedic Pin Protector

K883576510(k) TraditionalCleared Sep 30, 198839-day reviewClass II21 CFR 888.3030

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

Horizon Medical, Inc. · LYT Fixation Accessory

Cleared on Sep 30, 1988 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 30, 1988
Review
39 days
Class
Class II
Product code
LYT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K883576Source: FDA 510(k) database · 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), 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?

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

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.

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—

More from Horizon Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K980171Dermasense Plus Dispersive ElectrodeHorizon Medical, Inc. · 1998
  • K944969Steri-Lub Lubrication GelHorizon Medical, Inc. · 1995

Recent decisions in LYT

The LYT category page

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

https://510kreport.com/device/K883576 · printed Nov 4, 2026

Cite this page

510(k) Report. “K883576: Horizon Orthopedic Pin Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K883576

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