Cleared Traditional

K080522 - SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES

K080522 is the FDA 510(k) clearance for SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K080522 · Synthes (Usa) · Orthopedic device
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May 2008
Decision
87d
Days
Class 2
Risk

K080522 is an FDA 510(k) clearance for the SYNTHES 3.5 MM LCP DISTAL TIBIA T 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 23, 2008 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes (Usa) devices

Submission Details

510(k) Number K080522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2008
Decision Date May 23, 2008
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K080522.
ORTHOMESH
K073115 · Synthes (Usa) · Jul 2008
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K081373 · Wrightmedicaltechnologyinc · Jul 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139
K081106 · Smith & Nephew, Inc. · Jun 2008
AAP BONE PLATES AND SCREW IMPLANTS
K072411 · Aap Implantate AG · Mar 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667 · Howmedica Osteonics Corp. · Mar 2008
CHARLOTTE CLAW 3.5
K080295 · Wrightmedicaltechnologyinc · Feb 2008