Cleared Traditional

K092528 - BIOMET FORERUNNER LOCKING PLATE SYSTEM

K092528 is an FDA 510(k) clearance for BIOMET FORERUNNER LOCKING PLATE SYSTEM, manufactured by Biomet Trauma (Aka Ebi, Lp). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K092528 · Biomet Trauma (Aka Ebi, Lp) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
276d
Days
Class 2
Risk

K092528 is an FDA 510(k) clearance for the BIOMET FORERUNNER LOCKING PLATE SYSTEM. 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 Trauma (Aka Ebi, Lp) (Parsippany, US). The FDA issued a Cleared decision on May 21, 2010 after a review of 276 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 Trauma (Aka Ebi, Lp) devices

FDA 510(k) Submission Details - K092528

510(k) Number K092528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2009
Decision Date May 21, 2010
Days to Decision 276 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
154d slower than avg
Panel avg: 122d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1064
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K092528.
CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22
K101240 · DePuy Orthopaedics, Inc. · Jul 2010
ASCENSION ANKLE FUSION PLATE SYSTEM
K100176 · Ascension Orthopedics, Inc. · Jun 2010
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708
K101421 · DePuy Orthopaedics, Inc. · Jun 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240 · OrthoPediatrics Corp. · May 2010
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
K100271 · Howmedica Osteonics Corp. · May 2010
VARIAX ELBOW SYSTEM
K101056 · Howmedica Osteonics Corp. · May 2010