Cleared Traditional

K092812 - SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES

K092812 is an FDA 510(k) clearance for SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLA..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K092812 · Synthes (Usa) · Orthopedic device
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May 2010
Decision
239d
Days
Class 2
Risk

K092812 is an FDA 510(k) clearance for the SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on May 11, 2010 after a review of 239 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K092812

510(k) Number K092812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date May 11, 2010
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
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 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K092812.
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
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
K093978 · Exactech, Inc. · May 2010
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
K100475 · Howmedica Osteonics Corp. · Apr 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
K100618 · Orthohelix Surgical Designs, Inc. · Apr 2010