510(k) Report

510(k) · Cleared

Cleared

Cannulated Malleolar Screw

K931682510(k) TraditionalCleared Apr 5, 1994365-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

Onyx Medical Corp. · KWK Appliance, Nail/Blade/Plate Combination, Single Component

Cleared on Apr 5, 1994 after a 365-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 5, 1994
Review
365 days
Class
Class II
Product code
KWK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K931682Source: 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 KWK? 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 KWK devices

KWK Appliance, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWK

FDA has decided no KWK device since 2007.

Median 510(k) review, days · KWK

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

Recalls per year · KWK

No recall names KWK since 2007.

Adverse event reports per year · KWK

No MAUDE report names KWK since 2007.

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—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Onyx Medical Corp.

47 FDA decisions under this applicant name. See the company

  • K942022Face-IT ShieldOnyx Medical Corp. · 1994
  • K931690Spoon PlateOnyx Medical Corp. · 1994
  • K931692T-PlateOnyx Medical Corp. · 1994
  • K931680Cannulated Cancellous ScrewOnyx Medical Corp. · 1994
  • K934614Mini Fragment PlateOnyx Medical Corp. · 1994

https://510kreport.com/device/K931682 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931682: Cannulated Malleolar Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931682

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