510(k) Report

510(k) · Cleared

Cleared

Inserteo, Meta.-Phal.&Thumb Carpo-Meta

K771072510(k) TraditionalCleared Jun 27, 197713-day reviewClass I21 CFR 888.4540

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

Depuy, Inc. · HXO Pusher, Socket

Cleared on Jun 27, 1977 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 27, 1977
Review
13 days
Class
Class I
Product code
HXO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K771072Source: 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.

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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 HXO devices

HXO Pusher, Socket: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HXO

FDA has decided no HXO device since 2007.

Median 510(k) review, days · HXO

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

Recalls per year · HXO

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · HXO

1in 2025

2007: 22010: 72011: 42012: 42013: 62014: 22015: 32016: 42017: 52018: 12021: 22023: 22024: 52025: 1
2007high 7 (2010) · low 0 (2008)2025

MAUDE reports naming product code HXO, 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—02
20080—00
20090—00
20100—17
20110—04
20120—04
20130—06
20140—02
20150—03
20160—04
20170—05
20180—01
20190—00
20200—00
20210—02
20220—00
20230—02
20240—05
20250—01
20260—0—
Cite this page

510(k) Report. “K771072: Inserteo, Meta.-Phal.&Thumb Carpo-Meta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K771072

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