510(k) Report

510(k) · Decided

Decided

Smooth Staple Implant

K900433510(k) TraditionalDecided Nov 16, 1990290-day reviewClass II21 CFR 872.4760

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

Interphase Implants, Inc. · MDL Implant, Transmandibular

Cleared on Nov 16, 1990 after a 290-day review. The FDA summary names no predicate by number.

Decided
Nov 16, 1990
Review
290 days
Class
Class II
Product code
MDL
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K900433Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MDL? 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?

The FDA summary names no predicate by number.

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 MDL devices

MDL Implant, Transmandibular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MDL

FDA has decided no MDL device since 2007.

Median 510(k) review, days · MDL

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

Recalls per year · MDL

No recall names MDL since 2007.

Adverse event reports per year · MDL

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code MDL, 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—02
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—

Recent decisions in MDL

The MDL category page

  • K852894Ormco Transmandibular ImplantOrmco Corp. · 1985

https://510kreport.com/device/K900433 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900433: Smooth Staple Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900433

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026