Cleared Traditional

K896601 - EXACTECH BONE SCREW

K896601 is an FDA 510(k) clearance for EXACTECH BONE SCREW, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K896601 · Exactech, Inc. · Orthopedic device
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Dec 1989
Decision
15d
Days
Class 2
Risk

K896601 is an FDA 510(k) clearance for the EXACTECH BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on December 6, 1989 after a review of 15 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 Exactech, Inc. devices

FDA 510(k) Submission Details - K896601

510(k) Number K896601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date December 06, 1989
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

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 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K896601.
LAG SCREW
K903244 · Onyx Medical Corp. · Jul 1990
ACUFEX STERILE CANNULATED INTERFERENCE SCREW
K900132 · Acufex Microsurgical, Inc. · Mar 1990
ACUFEX INTERFERENCE SCREW, STERILE
K895711 · Acufex Microsurgical, Inc. · Jan 1990
DEPUY (TM) TRUE COMPRESSION SCREW
K895389 · Depuy, Inc. · Nov 1989
CROSS CANCELLOUS BONE SCREW
K896044 · Buckman Co., Inc. · Nov 1989
ASNIS II GUIDED BONE SCREW
K895766 · Howmedica Corp. · Nov 1989