Cleared Traditional

K895441 - ACROMED BUTTON SPINAL WIRE

K895441 is an FDA 510(k) clearance for ACROMED BUTTON SPINAL WIRE, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K895441 · Acromed Corp. · Orthopedic device
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Nov 1989
Decision
78d
Days
Class 2
Risk

K895441 is an FDA 510(k) clearance for the ACROMED BUTTON SPINAL WIRE. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on November 22, 1989 after a review of 78 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 Acromed Corp. devices

FDA 510(k) Submission Details - K895441

510(k) Number K895441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1989
Decision Date November 22, 1989
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K895441.
LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET
K890192 · Danek Medical, Inc. · Jan 1990
ACROMED DOUBLE SUBLAMINAR WIRE
K895413 · Acromed Corp. · Nov 1989
ACROMED BEADED SUBLAMINAR WIRE
K895439 · Acromed Corp. · Nov 1989
CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL
K894472 · Buckman Co., Inc. · Oct 1989
KIRSCHNER SPINAL FIXATOR KMS-1
K884690 · Kirschner Medical Corp. · Jun 1989
ACROMED ILIAC SCREW
K884161 · Buckman Co., Inc. · May 1989