Cleared Traditional

BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER (K071577) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071577 · Biomet Microfixation, Inc. · Orthopedic device
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Sep 2007
Decision
90d
Days
Class 2
Risk

K071577 is an FDA 510(k) clearance for the BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Biomet Microfixation, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 6, 2007 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 Microfixation, Inc. devices

Submission Details

510(k) Number K071577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2007
Decision Date September 06, 2007
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K071577.
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
K072423 · DePuy Orthopaedics, Inc. · Nov 2007
SMALL FRAGMENT LOCKING PLATING SYSTEM
K072083 · DePuy Orthopaedics, Inc. · Oct 2007
SMALL BONE WEDGE
K070592 · Wrightmedicaltechnologyinc · Oct 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563 · Smith & Nephew, Inc. · Aug 2007
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
K071264 · Synthes (Usa) · Jul 2007
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
K071184 · Synthes (Usa) · Jun 2007