Cleared Traditional

K130105 - RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130105 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device

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May 2013

Decision

122d

Days

Class 2

Risk

K130105 is an FDA 510(k) clearance for the RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS .... Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on May 17, 2013 after a review of 122 days - within the typical 510(k) review window.

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	K130105 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 15, 2013
Decision Date	May 17, 2013
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

At panel average

Panel avg: 122d · This submission: 122d

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.