Cleared Traditional

THACKRAY TITANIUM MINI-PLATING SYSTEM (K905774) - FDA 510(k) Clearance

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

K905774 · Depuy, Inc. · Orthopedic device
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Jun 1991
Decision
168d
Days
Class 2
Risk

K905774 is an FDA 510(k) clearance for the THACKRAY TITANIUM MINI-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 Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 13, 1991 after a review of 168 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 Depuy, Inc. devices

Submission Details

510(k) Number K905774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date June 13, 1991
Days to Decision 168 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 122d · This submission: 168d
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 K905774.
LUHR PAN FIXATION SYSTEM
K913355 · Howmedica Corp. · Dec 1991
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
K912932 · Synthes (Usa) · Sep 1991
ALTA CHANNEL PLATE CONNECTOR
K910482 · Howmedica Corp. · Jul 1991
DUPONT DISTAL HUMERAL NAIL
K890939 · Howmedica Corp. · May 1989
ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS
K885250 · Howmedica Corp. · Feb 1989
LUHR MICRO SYSTEM
K882454 · Howmedica Corp. · Aug 1988