Cleared Traditional

K082807 - SYNTHES (USA) 3.5 AND 4.5 MM LOCKING CO...

K082807 is the FDA 510(k) clearance for SYNTHES (USA) 3.5 AND 4.5 MM LOCKING CO... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K082807 · Synthes (Usa) · Orthopedic device
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Nov 2008
Decision
61d
Days
Class 2
Risk

K082807 is an FDA 510(k) clearance for the SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED I.... 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 November 24, 2008 after a review of 61 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 K082807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2008
Decision Date November 24, 2008
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
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 K082807.
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
K082527 · Zimmer, Inc. · Dec 2008
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
K082625 · Synthes (Usa) · Dec 2008
2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424
K083364 · DePuy Orthopaedics, Inc. · Dec 2008
SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES
K082624 · Synthes (Usa) · Nov 2008
SYNTHES (USA) 3.5MM LCP HOOK PLATE
K082072 · Synthes (Usa) · Nov 2008
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES
K082078 · Zimmer, Inc. · Nov 2008