Cleared Traditional

K090975 - DEROYAL NON-LOCKING BONE FIXATION SYSTEM

K090975 is an FDA 510(k) clearance for DEROYAL NON-LOCKING BONE FIXATION SYSTEM, 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 371-day FDA review.

K090975 · Deroyal Industries, Inc. · Orthopedic device
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Apr 2010
Decision
371d
Days
Class 2
Risk

K090975 is an FDA 510(k) clearance for the DEROYAL NON-LOCKING 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 Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on April 12, 2010 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K090975

510(k) Number K090975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date April 12, 2010
Days to Decision 371 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 122d · This submission: 371d
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 K090975.
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
K100475 · Howmedica Osteonics Corp. · Apr 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
K100618 · Orthohelix Surgical Designs, Inc. · Apr 2010
PEANUT GROWTH CONTROL PLATING SYSTEM
K093880 · Ebi, L.P. · Apr 2010
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K100111 · Zimmer, Inc. · Apr 2010
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
K100676 · Synthes (Usa) · Apr 2010
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928 · Synthes (Usa) · Mar 2010