Cleared Traditional

K070946 - SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA...

K070946 is the FDA 510(k) clearance for SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K070946 · Synthes (Usa) · Orthopedic device
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Jun 2007
Decision
63d
Days
Class 2
Risk

K070946 is an FDA 510(k) clearance for the SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS 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 June 6, 2007 after a review of 63 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 K070946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2007
Decision Date June 06, 2007
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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 K070946.
ACUMED CONGRUENT BONE PLATE SYSTEM
K071715 · Acumed, LLC · Jul 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
SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES
K070208 · Synthes (Usa) · Mar 2007
KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE
K070169 · KLS-Martin L.P. · Mar 2007
STRYKER FOOT PLATING SYSTEM
K063875 · Howmedica Osteonics Corp. · Mar 2007