Cleared Traditional

K133606 - N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL

K133606 is an FDA 510(k) clearance for N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, manufactured by ArthroCare Corporation. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K133606 · ArthroCare Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
127d
Days
Class 2
Risk

K133606 is an FDA 510(k) clearance for the N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE.... Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by ArthroCare Corporation (Austin, US). The FDA issued a Cleared decision on April 1, 2014 after a review of 127 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 ArthroCare Corporation devices

FDA 510(k) Submission Details - K133606

510(k) Number K133606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2013
Decision Date April 01, 2014
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K133606.
ICONN ANSWER SUTURE ANCHOR
K132724 · Iconn Orthopedics, LLC · Apr 2014
THREADED PEEK K-WIRE
K133235 · Mtp Solutions, LLC · Apr 2014
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133777 · Tornier, Inc. · Apr 2014
ACUMED SUTURE ANCHOR SYSTEM
K133469 · Acumed, LLC · Mar 2014
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
K133036 · Amendia, Inc. · Mar 2014
ICONIX ALL SUTURE ANCHORS
K133671 · Stryker Corp. · Feb 2014