Cleared Traditional

K894472 - CROSS ROUND & SQUARE SPINAL RODS & DIST...

K894472 is the FDA 510(k) clearance for CROSS ROUND & SQUARE SPINAL RODS & DIST... by Buckman Co., Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K894472 · Buckman Co., Inc. · Orthopedic device
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Oct 1989
Decision
84d
Days
Class 2
Risk

K894472 is an FDA 510(k) clearance for the CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on October 10, 1989 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K894472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date October 10, 1989
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 281
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K894472.
ACROMED DOUBLE SUBLAMINAR WIRE
K895413 · Acromed Corp. · Nov 1989
ACROMED BEADED SUBLAMINAR WIRE
K895439 · Acromed Corp. · Nov 1989
ACROMED BUTTON SPINAL WIRE
K895441 · Acromed Corp. · Nov 1989
KIRSCHNER SPINAL FIXATOR KMS-1
K884690 · Kirschner Medical Corp. · Jun 1989
ACROMED ILIAC SCREW
K884161 · Buckman Co., Inc. · May 1989
ACROMED SPINAL ROD AND SPINAL HOOKS
K884163 · Buckman Co., Inc. · Apr 1989