510(k) Report

510(k) · Cleared

Cleared

WIRE

K841628510(k) TraditionalCleared Jul 23, 198495-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

Plastafil, Inc. · HXN Applier, Cerclage

Cleared on Jul 23, 1984 after a 95-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 23, 1984
Review
95 days
Class
Class I
Product code
HXN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K841628Source: 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 HXN? 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 HXN devices

HXN Applier, Cerclage: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HXN

FDA has decided no HXN device since 2007.

Median 510(k) review, days · HXN

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

Recalls per year · HXN

No recall names HXN since 2007.

Adverse event reports per year · HXN

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code HXN, 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—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Plastafil, Inc.

13 FDA decisions under this applicant name. See the company

  • K841620Front Radius CutterPlastafil, Inc. · 1984
  • K841621Back Radius CutterPlastafil, Inc. · 1984
  • K841626PUNCHPlastafil, Inc. · 1984
  • K841629Drill BitPlastafil, Inc. · 1984
  • K841625HOOKPlastafil, Inc. · 1984

Recent decisions in HXN

The HXN category page

  • K024022Osteo-Cable SleeveBiomet, Inc. · 2003

https://510kreport.com/device/K841628 · printed Nov 4, 2026

Cite this page

510(k) Report. “K841628: WIRE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K841628

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