Cleared Traditional

K021071 - PCCS GRAFT DELIVERY SYSTEM

K021071 is the FDA 510(k) clearance for PCCS GRAFT DELIVERY SYSTEM by Biomet, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K021071 · Biomet, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2002
Decision
90d
Days
Class 2
Risk

K021071 is an FDA 510(k) clearance for the PCCS GRAFT DELIVERY SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

Submission Details

510(k) Number K021071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date July 01, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K021071.
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K023271 · Terumo Medical Corp. · Dec 2002
BONE GRAFT SYRINGE, MODEL 8600-00X0
K023088 · Wrightmedicaltechnologyinc · Oct 2002
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246 · Depuyacromed · Aug 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · Baxter Healthcare Corp · Jun 2002
DUPLOREACH
K014088 · Baxter Healthcare Corp · Jun 2002
APPLICATOR TIP/DUAL SPRAYER KIT
K010708 · Interpore Cross Intl. · Apr 2001