Cleared Traditional

K895766 - ASNIS II GUIDED BONE SCREW

K895766 is the FDA 510(k) clearance for ASNIS II GUIDED BONE SCREW by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K895766 · Howmedica Corp. · Orthopedic device
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Nov 1989
Decision
43d
Days
Class 2
Risk

K895766 is an FDA 510(k) clearance for the ASNIS II GUIDED BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on November 8, 1989 after a review of 43 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 Howmedica Corp. devices

Submission Details

510(k) Number K895766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date November 08, 1989
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K895766.
EXACTECH BONE SCREW
K896601 · Exactech, Inc. · Dec 1989
DEPUY (TM) TRUE COMPRESSION SCREW
K895389 · Depuy, Inc. · Nov 1989
CROSS CANCELLOUS BONE SCREW
K896044 · Buckman Co., Inc. · Nov 1989
CORTICAL SCREW
K895217 · Orthopedic Systems, Inc. · Sep 1989
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM
K895218 · Orthopedic Systems, Inc. · Sep 1989
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
K895219 · Orthopedic Systems, Inc. · Sep 1989