Cleared Traditional

K071809 - ENSPLINTRX BONE FIXATION SYSTEM

K071809 is an FDA 510(k) clearance for ENSPLINTRX BONE FIXATION SYSTEM, manufactured by Sonoma Orthopedic Products, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K071809 · Sonoma Orthopedic Products, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
234d
Days
Class 2
Risk

K071809 is an FDA 510(k) clearance for the ENSPLINTRX BONE FIXATION 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 Sonoma Orthopedic Products, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on February 21, 2008 after a review of 234 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sonoma Orthopedic Products, Inc. devices

FDA 510(k) Submission Details - K071809

510(k) Number K071809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date February 21, 2008
Days to Decision 234 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 122d · This submission: 234d
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 1043
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K071809.
MODULAR FOOT SYSTEM
K073624 · Orthohelix Surgical Designs, Inc. · Mar 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667 · Howmedica Osteonics Corp. · Mar 2008
CHARLOTTE CLAW 3.5
K080295 · Wrightmedicaltechnologyinc · Feb 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K073460 · Synthes (Usa) · Feb 2008
BIOFOAM BONE WEDGE
K073535 · Wrightmedicaltechnologyinc · Jan 2008
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
K073186 · Synthes (Usa) · Dec 2007