Cleared Traditional

K141263 - TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS

K141263 is an FDA 510(k) clearance for TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRU..., manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K141263 · Biomet Manufacturing Corp · Orthopedic device
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Nov 2014
Decision
188d
Days
Class 2
Risk

K141263 is an FDA 510(k) clearance for the TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on November 19, 2014 after a review of 188 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 Biomet Manufacturing Corp devices

FDA 510(k) Submission Details - K141263

510(k) Number K141263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2014
Decision Date November 19, 2014
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
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 197
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K141263.
OS2-V Varisation Staple
K143323 · In2bones Sas · Feb 2015
SnapShot Fixation System
K143037 · Biomet Manufacturing Corp · Jan 2015
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE
K142111 · Novatsep · Dec 2014
Speed, Speed Shift, Speed Titan, Speed Arc
K142292 · Biomedical Enterprises, Inc. · Nov 2014
CrossCLIP Implant System
K142727 · Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems · Oct 2014
ORTHOHELIX STAPLE SYSTEM
K142148 · Orthohelix Surgical Designs, Inc. · Aug 2014