Cleared Traditional

K900132 - ACUFEX STERILE CANNULATED INTERFERENCE ...

K900132 is the FDA 510(k) clearance for ACUFEX STERILE CANNULATED INTERFERENCE ... by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K900132 · Acufex Microsurgical, Inc. · Orthopedic device
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Mar 1990
Decision
77d
Days
Class 2
Risk

K900132 is an FDA 510(k) clearance for the ACUFEX STERILE CANNULATED INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Norwood, US). The FDA issued a Cleared decision on March 28, 1990 after a review of 77 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 Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K900132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1990
Decision Date March 28, 1990
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 562
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K900132.
HAGIE PIN
K903258 · Onyx Medical Corp. · Aug 1990
KNOWLES PIN
K903259 · Onyx Medical Corp. · Aug 1990
LAG SCREW
K903244 · Onyx Medical Corp. · Jul 1990
ACUFEX INTERFERENCE SCREW, STERILE
K895711 · Acufex Microsurgical, Inc. · Jan 1990
EXACTECH BONE SCREW
K896601 · Exactech, Inc. · Dec 1989
DEPUY (TM) TRUE COMPRESSION SCREW
K895389 · Depuy, Inc. · Nov 1989