Cleared Traditional

K943492 - ARTHREX STAPLES

K943492 is an FDA 510(k) clearance for ARTHREX STAPLES, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K943492

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.

JDR Device Classification - Class 2, Special Controls

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 191
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K943492.
BIOABSORBABLE INTERFERENCE SCREW
K943548 · Acufex Microsurgical, Inc. · Mar 1995
MITEK THRADED ANCHOR (MTA)
K945203 · Mitek Surgical Products, 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
MITEK GIII ANCHOR
K931782 · Mitek Surgical Products, Inc. · Jul 1994