Cleared Traditional

K103145 - HAMMERLOC TM TIBIAL FIXATION DEVICE

K103145 is the FDA 510(k) clearance for HAMMERLOC TM TIBIAL FIXATION DEVICE by Biomet Sports Medicine. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K103145 · Biomet Sports Medicine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
107d
Days
Class 2
Risk

K103145 is an FDA 510(k) clearance for the HAMMERLOC TM TIBIAL FIXATION DEVICE. 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 February 9, 2011 after a review of 107 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 Biomet Sports Medicine devices

Submission Details

510(k) Number K103145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2010
Decision Date February 09, 2011
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 K103145.
5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP
K110781 · Arthrocare Corp. · May 2011
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
K103262 · Tornier, Inc. · Apr 2011
BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
K110145 · Biomet, Inc. · Mar 2011
5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
K110164 · Arthrocare Corp. · Feb 2011
ARTHREX TIBIAL GRAFTBOLT
K103060 · Arthrex, Inc. · Jan 2011
SPEEDFIX SUTURE SYSTEM
K101437 · Arthrocare Corp. · Oct 2010