Cleared Traditional

K143037 - SnapShot Fixation System

K143037 is an FDA 510(k) clearance for SnapShot Fixation System, 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 90-day FDA review.

K143037 · Biomet Manufacturing Corp · Orthopedic device
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Jan 2015
Decision
90d
Days
Class 2
Risk

K143037 is an FDA 510(k) clearance for the SnapShot Fixation System. 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 January 20, 2015 after a review of 90 days - within the typical 510(k) review window.

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 - K143037

510(k) Number K143037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2014
Decision Date January 20, 2015
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K143037.
dynaMX Compression Staple
K143622 · Mx Orthopedics, Corp. · Jun 2015
Elite Nitinol Fixation System
K150125 · Biomedical Enterprises, Inc. · May 2015
OS2-V Varisation Staple
K143323 · In2bones Sas · Feb 2015
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE
K142111 · Novatsep · Dec 2014
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · Biomet Manufacturing Corp · Nov 2014
Speed, Speed Shift, Speed Titan, Speed Arc
K142292 · Biomedical Enterprises, Inc. · Nov 2014