Cleared Traditional

K094037 - TC PLATING SYSTEM

K094037 is an FDA 510(k) clearance for TC PLATING SYSTEM, manufactured by Ortho-Pro, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K094037 · Ortho-Pro, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
70d
Days
Class 2
Risk

K094037 is an FDA 510(k) clearance for the TC 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 Ortho-Pro, LLC (Round Rock, US). The FDA issued a Cleared decision on March 10, 2010 after a review of 70 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.

FDA 510(k) Submission Details - K094037

510(k) Number K094037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2009
Decision Date March 10, 2010
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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 1321
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K094037.
SYNTHES STERNAL FIXATION SYSTEM
K093772 · Synthes · Mar 2010
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928 · Synthes (Usa) · Mar 2010
SMPLE PLATE AND SCREWS
K093983 · Biomet Trauma (Aka Ebi, Lp) · Mar 2010
OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM
K093761 · Biomet Trauma (Aka Ebi, Lp) · Mar 2010
EDGELOCK
K093900 · Orthohelix Surgical Designs, Inc. · Feb 2010
ORTHO SELECT BONE PLATES AND SCREW SYSTEM
K091493 · Ortho Select Implant Technology Gesellschaft · Feb 2010
K094037 · TC PLATING SYSTEM
Download PDF FDA Summary Ortho-Pro, LLC