Cleared Traditional

K901234 - KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. ...

K901234 is an FDA 510(k) clearance for KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. ..., manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K901234 · Kirschner Medical Corp. · Orthopedic device
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Oct 1990
Decision
204d
Days
Class 2
Risk

K901234 is an FDA 510(k) clearance for the KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on October 4, 1990 after a review of 204 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K901234

510(k) Number K901234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date October 04, 1990
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K901234.
HOFFMANN DYNAMIC WRIST FIXATOR
K910986 · Howmedica Corp. · Jan 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · Synthes (Usa) · Jan 1992
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162 · Smith & Nephew Richards, Inc. · Aug 1991
SIDE PLATE
K903246 · Onyx Medical Corp. · Jul 1990
BLADE PLATE
K903250 · Onyx Medical Corp. · Jul 1990
JEWETT HIP NAIL
K903251 · Onyx Medical Corp. · Jul 1990