Cleared Traditional

SALVATION 3DI PLATING SYSTEM (K140792) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140792 · Wrightmedicaltechnologyinc · Orthopedic device
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May 2014
Decision
52d
Days
Class 2
Risk

K140792 is an FDA 510(k) clearance for the SALVATION 3DI PLATING 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 Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on May 22, 2014 after a review of 52 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K140792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date May 22, 2014
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
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 695
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K140792.
BIOFOAM BONE WEDGE
K140531 · Wrightmedicaltechnologyinc · Jul 2014
CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW
K141417 · Wrightmedicaltechnologyinc · Jul 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478 · Arthrex, Inc. · Jul 2014
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
K140622 · Biomet, Inc. · May 2014
EVOS MINI-FRAGMENT PLATING SYSTEM
K140814 · Smith & Nephew, Inc. · May 2014
CHARLOTTE CLAW PLATE SYSTEM
K133715 · Wrightmedicaltechnologyinc · Feb 2014