510(k) Report

510(k) · Cleared

Cleared

Fisch Modified Total Ossicular Prosthes

K823442510(k) TraditionalCleared Dec 3, 198217-day reviewClass II21 CFR 874.3450

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

Treace Medical, Inc. · LBM Porous Polyethylene Ossicular Replacement

Cleared on Dec 3, 1982 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 3, 1982
Review
17 days
Class
Class II
Product code
LBM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K823442Source: 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 LBM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 LBM devices

LBM Porous Polyethylene Ossicular Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBM

FDA has decided no LBM device since 2007.

Median 510(k) review, days · LBM

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

Recalls per year · LBM

No recall names LBM since 2007.

Adverse event reports per year · LBM

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code LBM, 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—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Treace Medical, Inc.

80 FDA decisions under this applicant name. See the company

  • K883727Bucket Prosthesis PorpTreace Medical, Inc. · 1989
  • K882349Mallet, SurgicalTreace Medical, Inc. · 1988
  • K874779Bipolator 50Treace Medical, Inc. · 1988
  • K873154Treace Magnum Oto-Tool SystemTreace Medical, Inc. · 1987
  • K872000Eye GardTreace Medical, Inc. · 1987

Recent decisions in LBM

The LBM category page

  • K823441Austin Modified Total Ossicular ReplaceTreace Medical, Inc. · 1982

https://510kreport.com/device/K823442 · printed Nov 5, 2026

Cite this page

510(k) Report. “K823442: Fisch Modified Total Ossicular Prosthes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K823442

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