Shortening Osteotomy Guide

K861576510(k) TraditionalCleared May 12, 198614-day reviewClass I21 CFR 888.4600

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

Cleared on May 12, 1986 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: May 12, 1986
Review: 14 days
Class: Class I
Product code: HTH
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K861576Source: FDA 510(k) database · How lineage is built

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.

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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 HTH devices

HTH Protractor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTH

FDA has decided no HTH device since 2007.

Median 510(k) review, days · HTH

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

Recalls per year · HTH

No recall names HTH since 2007.

Adverse event reports per year · HTH

No MAUDE report names HTH since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K861576 · printed Nov 6, 2026

Cite this page

510(k) Report. “K861576: Shortening Osteotomy Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861576

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Record history

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