Cleared Traditional

K083070 - TOGGLELOC SYSTEM

K083070 is the FDA 510(k) clearance for TOGGLELOC SYSTEM by Biomet Sports Medicine. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K083070 · Biomet Sports Medicine · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2008
Decision
62d
Days
Class 2
Risk

K083070 is an FDA 510(k) clearance for the TOGGLELOC SYSTEM. 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 Biomet Sports Medicine (Warsaw, US). The FDA issued a Cleared decision on December 16, 2008 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet Sports Medicine devices

Submission Details

510(k) Number K083070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2008
Decision Date December 16, 2008
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K083070.
MAGNUM M FIXATION DEVICE
K090380 · Arthrocare Corp. · Mar 2009
G-FORCE TENODESIS SCREW
K083150 · Wrightmedicaltechnologyinc · Jan 2009
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
K083240 · Arthrocare Corp. · Jan 2009
TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
K081348 · TriMed, Inc. · Oct 2008
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S
K081511 · Smith & Nephew, Inc. · Aug 2008
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)
K081497 · Arthrocare Corp. · Jul 2008