Cleared Traditional

K895711 - ACUFEX INTERFERENCE SCREW, STERILE

K895711 is an FDA 510(k) clearance for ACUFEX INTERFERENCE SCREW, manufactured by Acufex Microsurgical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K895711 · Acufex Microsurgical, Inc. · Orthopedic device
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Jan 1990
Decision
106d
Days
Class 2
Risk

K895711 is an FDA 510(k) clearance for the ACUFEX INTERFERENCE SCREW, STERILE. 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 January 9, 1990 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Acufex Microsurgical, Inc. devices

FDA 510(k) Submission Details - K895711

510(k) Number K895711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date January 09, 1990
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K895711.
LAG SCREW
K903244 · Onyx Medical Corp. · Jul 1990
CANNULATED INTERFERENCE SCREW SYSTEM
K901616 · Smith & Nephew Dyonics, Inc. · Jun 1990
ACUFEX STERILE CANNULATED INTERFERENCE SCREW
K900132 · Acufex Microsurgical, Inc. · Mar 1990
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