FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES

K970257 · Ferguson Medical · HSB · May 22, 1997 · Orthopedic

Device Facts

• Record ID: K970257
• Device Name: FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES
• Applicant: Ferguson Medical
• Product Code: HSB · Orthopedic
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The D.S.S. System For Osteosynthesis of Sub-Trochanterian Fractures is intended for use in the fixation and osteosynthesis of sub-trochanterian fractures.

Device Story

The Fixano D.S.S. (Double Sliding Screws) System is an implantable orthopedic device designed for the osteosynthesis of sub-trochanterian fractures. The system consists of a hip screw mechanism utilizing double sliding screws in combination with an intramedullary nail. The device is intended for use by orthopedic surgeons in a clinical or hospital setting to provide stability during the healing of sub-trochanteric fractures. By providing a sliding screw mechanism, the device facilitates fracture fixation, potentially improving patient outcomes through enhanced mechanical stability at the fracture site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hip screw mechanism; utilizes double sliding screws combined with an intramedullary nail; metallic implantable orthopedic hardware; designed for sub-trochanterian fracture fixation.

Indications for Use

Indicated for the fixation of subtrochanteric fractures in patients requiring orthopedic trauma surgery.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Fixano D.S.S. (Double Sliding Screws) System (K954757)
• Howmedica Alta CFX IM Rod System (K960524)
• Howmedica Gamma Locking Nail (K932174)
• Howmedica Gamma Locking Nail -- Long Length (K944883)

Submission Summary (Full Text)

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K970257

AM

FERGUSON

MEDICAL

MAY 22 1997

916-342-4133

FAX: [phone]

15 January 1997

510(k) SUMMARY

The 510(k) summary information required by 21 CFR 807.92 is as follows:

A. Classification name: Screw, fixation, bone, or appliance, fixation, nail/plate/blade combination, multiple component.

Common/Usual name: Hip screw, hip pin, hip screw and nail, etc.

Proprietary name: Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian Fractures.

B. Substantial equivalence: Fixano D.S.S. (Double Sliding Screws) System (K954757), Howmedica Alta CFX IM Rod System (K960524), Howmedica Gamma Locking Nail (K932174), Howmedica Gamma Locking Nail -- Long Length (K944883), and others.

C. Device description: The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian Fractures is an implantable device to be used in orthopedic trauma procedures.

3407 Bay Avenue • Chico, California 95973 • USA

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D. Intended use: The D.S.S. System For Osteosynthesis of Sub-Trochanterian Fractures is intended for use in the fixation and osteosynthesis of sub-trochanterian fractures.

E. Technological characteristics: The D.S.S. System For Osteosynthesis of Sub-Trochanterian Fractures is a hip screw mechanism that utilizes the D.S.S. sliding screws in combination with an intramedullary nail. This allows for maximum stability in the osteosynthesis of most sub-trochanterian fractures.

Submitted,
FERGUSON MEDICAL
FDA Establishment Registration Number 2937794

Frank Ferguson
Official Correspondent

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 22 1997

Mr. Frank Ferguson
Official Correspondent
Ferguson Medical
3407 Bay Avenue
Chico, California 95973

Re: K970257
Fixano Double Sliding Screws (D.D.S.) with Intramedullary Nail
K970258
Fixano Double Sliding Screws (D.D.S.) and Mini-Plate
K970280
Fixano Double Sliding Screws (D.D.S.) and Sid Plate Regulatory Class: II
Product Codes: HSB, HRS and HRS
Dated: April 15, 1997
Received: April 21, 1997

Dear Mr. Ferguson:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in

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Page 2 - Mr. Frank Ferguson

the Federal Register. Please note: this response to your
premarket notification submission does not affect any
obligation you might have under sections 531 through 542 of
the Act for devices under the Electronic Product Radiation
Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as
described in your 510(k) premarket notification. The FDA
finding of substantial equivalence of your devices to legally
marketed predicate devices results in a classification for
your devices and thus, permits your devices to proceed to the
market.

If you desire specific advice for your devices on our labeling
regulation (21 CFR Part 801 and additionally 809.10 for in
vitro diagnostic devices), please contact the Office of
Compliance at [phone]. Additionally, for questions on
the promotion and advertising of your devices, please contact
the Office of Compliance at [phone]. Also, please note
the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general
information on your responsibilities under the Act may be
obtained from the Division of Small Manufacturers Assistance
at its toll-free number [phone] or [phone] or at
its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosures

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Page 1 of 1

10(k) Number (If known): K970257

Device Name: Fixano DSS (Double Sliding Screw) System For Osteosynthesis of Sub-Trochanterian Fractures

Indications For Use:

This device is indicated for use in the fixation of subtrochanteric fractures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTEHR PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐ (Optional Format 1-2-96)