Cleared Traditional

K092317 - DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM

K092317 is an FDA 510(k) clearance for DEROYAL NON-STERILE LOCKING COMPRESSION..., manufactured by Deroyal Industries, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K092317 · Deroyal Industries, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
90d
Days
Class 2
Risk

K092317 is an FDA 510(k) clearance for the DEROYAL NON-STERILE LOCKING COMPRESSION PLATE 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 Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on November 2, 2009 after a review of 90 days - within the typical 510(k) review window.

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 Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K092317

510(k) Number K092317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date November 02, 2009
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K092317.
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
K092178 · Howmedica Osteonics Corp. · Nov 2009
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
K092556 · Synthes (Usa) · Nov 2009
SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)
K092609 · Synthes (Usa) · Nov 2009
ANKLE ARTHRODESIS PLATE SYSTEM
K090139 · Tornier, Inc. · Oct 2009
SYNTHES LOCKING HAND PLATES
K092247 · Synthes (Usa) · Sep 2009
VARIAX ELBOW SYSTEM LINE EXTENSION
K092671 · Howmedica Osteonics Corp. · Sep 2009