Cleared Traditional

K905355 - BROAD SELF-COMPRESSING PLATE

K905355 is an FDA 510(k) clearance for BROAD SELF-COMPRESSING PLATE, manufactured by O'Tec Corp.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K905355 · O'Tec Corp. · Orthopedic device
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Jan 1991
Decision
37d
Days
Class 2
Risk

K905355 is an FDA 510(k) clearance for the BROAD SELF-COMPRESSING PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by O'Tec Corp. (Memphis, US). The FDA issued a Cleared decision on January 4, 1991 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all O'Tec Corp. devices

FDA 510(k) Submission Details - K905355

510(k) Number K905355 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 28, 1990
Decision Date January 04, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 122d · This submission: 37d
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 1006
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K905355.
MASTERPIECES MICRO SYSTEM
K910957 · Storz Instrument Co. · Jul 1991
TMP MANDIBULAR COMPRESSION SYSTEM
K905024 · Techmedica, Inc. · Jun 1991
THACKRAY TITANIUM MINI-PLATING SYSTEM
K905774 · Depuy, Inc. · Jun 1991
BROAD SELF-COMPRESSING PLATE
K903252 · Onyx Medical Corp. · Aug 1990
INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
K892228 · Intermedics Orthopedics · Oct 1989
DUPONT DISTAL HUMERAL NAIL
K890939 · Howmedica Corp. · May 1989