Cleared Traditional

FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES (K970257) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970257 · Ferguson Medical · Orthopedic device
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May 1997
Decision
119d
Days
Class 2
Risk

K970257 is an FDA 510(k) clearance for the FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHA.... Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on May 22, 1997 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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

Submission Details

510(k) Number K970257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1997
Decision Date May 22, 1997
Days to Decision 119 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K970257.
ALTA INTRAMEDULLARY ROD SYSTEM
K972108 · Howmedica Corp. · Aug 1997
ATLAS FRACTURE PROXIMAL HUMERAL NAIL
K971816 · Biomet, Inc. · Jul 1997
MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM
K971135 · Wrightmedicaltechnologyinc · Jun 1997
INTRAMEDULLARY NAIL SYSTEM
K965098 · Zimmer, Inc. · Feb 1997
SUPRACONDYLAR INTRAMEDULLARY NAIL
K962561 · Zimmer, Inc. · Sep 1996
ALTA CFX IM ROD SYSTEM
K960524 · Howmedica Corp. · Mar 1996