Cleared Traditional

CROSS CANCELLOUS BONE SCREW (K896044) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896044 · Buckman Co., Inc. · Orthopedic device
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Nov 1989
Decision
23d
Days
Class 2
Risk

K896044 is an FDA 510(k) clearance for the CROSS CANCELLOUS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on November 9, 1989 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 K896044 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 17, 1989
Decision Date November 09, 1989
Days to Decision 23 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K896044.
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · Howmedica Corp. · Jun 1991
EXACTECH BONE SCREW
K896601 · Exactech, Inc. · Dec 1989
DEPUY (TM) TRUE COMPRESSION SCREW
K895389 · Depuy, Inc. · Nov 1989
ASNIS II GUIDED BONE SCREW
K895766 · Howmedica Corp. · Nov 1989
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
K894124 · Osteonics Corp. · Sep 1989
DEPUY CANNULATED BONE SCREW
K893512 · Depuy, Inc. · Aug 1989