Cleared Traditional

K954757 - FIXANO D.D.S. (DOUBLE SLIDING SCREW)

K954757 is an FDA 510(k) clearance for FIXANO D.D.S. (DOUBLE SLIDING SCREW), manufactured by Ferguson Medical. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K954757 · Ferguson Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
101d
Days
Class 2
Risk

K954757 is an FDA 510(k) clearance for the FIXANO D.D.S. (DOUBLE SLIDING SCREW). Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on January 25, 1996 after a review of 101 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 Ferguson Medical devices

FDA 510(k) Submission Details - K954757

510(k) Number K954757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1995
Decision Date January 25, 1996
Days to Decision 101 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 122d · This submission: 101d
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 972
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K954757.
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246 · Acufex Microsurgical, Inc. · Feb 1996
MLI INTERFERENCE SCREW
K953350 · Medicinelodge, Inc. · Jan 1996
ARTHREX BIOABSORBABLE INTERFERENCE SCREW
K945303 · Arthrex, Inc. · Jan 1996
SUPER SCREW 3.5 MM
K954330 · Osteomed Corp. · Dec 1995
DEPUY STAINLESS STEEL SET SCREW
K953650 · Depuy, Inc. · Nov 1995
6.5MM SOLID CANCELLOUS BONE SCREW
K954485 · Ace Medical Co. · Oct 1995