Cleared Traditional

K943492 - ARTHREX STAPLES

K943492 is the FDA 510(k) clearance for ARTHREX STAPLES by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K943492 · Arthrex, Inc. · Orthopedic device
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Feb 1995
Decision
197d
Days
Class 2
Risk

K943492 is an FDA 510(k) clearance for the ARTHREX STAPLES. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on February 1, 1995 after a review of 197 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K943492 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 19, 1994
Decision Date February 01, 1995
Days to Decision 197 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 122d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 99
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K943492.
ACUFEX TAG(R) BIOABSORBABLE ANCHORS
K946346 · Acufex Microsurgical, Inc. · Apr 1995
BIOABSORBABLE INTERFERENCE SCREW
K943548 · Acufex Microsurgical, Inc. · Mar 1995
ACUFEX TAG ANCHOR
K934867 · Acufex Microsurgical, Inc. · Feb 1995
BONE ANCHOR
K942787 · Acu Med, Inc. · Dec 1994
INNOVASIVE SUTURE BONE FASTENER WITH SUTURE
K935321 · Innovasive Devices, Inc. · Oct 1994
ACUFEX SURETAC
K931519 · Acufex Microsurgical, Inc. · Jun 1994