Cleared Traditional

K041075 - FASTIN RC ANCHOR

K041075 is the FDA 510(k) clearance for FASTIN RC ANCHOR by Depuy Mitek, A Johnson & Johnson Company. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K041075 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
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Nov 2004
Decision
197d
Days
Class 2
Risk

K041075 is an FDA 510(k) clearance for the FASTIN RC ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Norwood, US). The FDA issued a Cleared decision on November 9, 2004 after a review of 197 days - an extended review cycle.

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: 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 Depuy Mitek, A Johnson & Johnson Company devices

Submission Details

510(k) Number K041075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date November 09, 2004
Days to Decision 197 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
75d slower than avg
Panel avg: 122d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 554
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K041075.
BIO-CORE INTERFERENCE SCREW
K042552 · Biomet, Inc. · Dec 2004
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SPIRALOK ANCHOR
K041069 · Depuy Mitek, A Johnson & Johnson Company · Nov 2004
ARTHREX TRIMIT FAMILY
K041189 · Arthrex, Inc. · Nov 2004
ARTHREX TENODESIS SCREW FAMILY
K041356 · Arthrex, Inc. · Nov 2004
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
K042778 · Linvatec Corp. · Nov 2004