Cleared Traditional

K954246 - ACUFEX ENDOFIX ABSORBABLE INTERFERENCE ...

K954246 is the FDA 510(k) clearance for ACUFEX ENDOFIX ABSORBABLE INTERFERENCE ... by Acufex Microsurgical, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K954246 · Acufex Microsurgical, Inc. · Orthopedic device
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Feb 1996
Decision
157d
Days
Class 2
Risk

K954246 is an FDA 510(k) clearance for the ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on February 15, 1996 after a review of 157 days - an extended review 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: 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

Submission Details

510(k) Number K954246 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 11, 1995
Decision Date February 15, 1996
Days to Decision 157 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
35d slower than avg
Panel avg: 122d · This submission: 157d
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 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K954246.
DEPUY ADVANTAGE FIXATION SCREW SYSTEM
K961234 · Depuy, Inc. · Jun 1996
DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS
K960704 · Depuy, Inc. · Jun 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837 · Wrightmedicaltechnologyinc · Mar 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303 · Arthrex, Inc. · Jan 1996
FIXANO D.D.S. (DOUBLE SLIDING SCREW)
K954757 · Ferguson Medical · Jan 1996
DEPUY STAINLESS STEEL SET SCREW
K953650 · Depuy, Inc. · Nov 1995