Cleared Traditional

K991971 - ARTHREX CHONDRAL DART

K991971 is the FDA 510(k) clearance for ARTHREX CHONDRAL DART by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HTY) cleared through the Traditional 510(k) pathway after a 420-day FDA review.

K991971 · Arthrex, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
420d
Days
Class 2
Risk

K991971 is an FDA 510(k) clearance for the ARTHREX CHONDRAL DART, MODEL AR-4005B-18. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 420 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K991971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1999
Decision Date August 04, 2000
Days to Decision 420 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
298d slower than avg
Panel avg: 122d · This submission: 420d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HTY Pin, Fixation, Smooth

All 96
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K991971.
2MM PEDIATRIC FLEX NAIL
K022531 · Biomet, Inc. · Aug 2002
RESORBABLE BONE PINS
K011522 · Biomet, Inc. · Jul 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · Synthes (Usa) · Apr 2001
LACTOSORB BONE PIN
K990291 · Biomet, Inc. · Mar 1999
RETROGRADE PEDIATRIC NAIL
K980854 · Encore Orthopedics, Inc. · Aug 1998
SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION
K973240 · Synthes (Usa) · Nov 1997