Cleared Traditional

K905380 - 1-CUT ACL GRAFT KNIFE

K905380 is the FDA 510(k) clearance for 1-CUT ACL GRAFT KNIFE by Depuy, Inc.. It is a Class 1 General & Plastic Surgery device (product code GDX) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K905380 · Depuy, Inc. · General & Plastic Surgery device
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Dec 1990
Decision
13d
Days
Class 1
Risk

K905380 is an FDA 510(k) clearance for the 1-CUT ACL GRAFT KNIFE. Classified as Scalpel, One-piece (product code GDX), Class I - General Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 13, 1990 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy, Inc. devices

Submission Details

510(k) Number K905380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1990
Decision Date December 13, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDX Scalpel, One-piece
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDX Scalpel, One-piece

All 10
Devices cleared under the same product code (GDX) and FDA review panel - the closest regulatory comparables to K905380.
ICAN CYLINDRICAL SPONGES
K914086 · Icn Pharmaceuticals, Inc. · Oct 1991
CCI CORNEAL SCARIFIER
K904505 · Buckman Co., Inc. · Apr 1991
7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1
K851751 · Artiberia · Jun 1985
H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48
K834541 · Imm Enterprises , Ltd. · Jan 1984
PILLING DIAMOND KNIFE
K822749 · Narco Scientific · Oct 1982
DISPOSABLE #11 SCALPEL BLADE W/SHORT
K820869 · Van-Tec, Inc. · May 1982