Cleared Traditional

K905774 - THACKRAY TITANIUM MINI-PLATING SYSTEM

K905774 is an FDA 510(k) clearance for THACKRAY TITANIUM MINI-PLATING SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 168-day FDA review.

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

FDA 510(k) Submission Details - K905774

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.

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 1276
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K905774.
ALTA CHANNEL PLATE CONNECTOR
K910482 · Howmedica Corp. · Jul 1991
MASTERPIECES MICRO SYSTEM
K910957 · Storz Instrument Co. · Jul 1991
TMP MANDIBULAR COMPRESSION SYSTEM
K905024 · Techmedica, Inc. · Jun 1991
ACE RECONSTRUCTIVE PLATE
K905595 · Ace Medical Co. · Mar 1991
BROAD SELF-COMPRESSING PLATE
K905355 · O'Tec Corp. · Jan 1991
BROAD SELF-COMPRESSING PLATE
K903252 · Onyx Medical Corp. · Aug 1990