MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
Device Facts
| Record ID | K012967 |
|---|---|
| Device Name | MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM |
| Applicant | Disco-O-Tech Medical Technologies, Ltd. |
| Product Code | HSB · Orthopedic |
| Decision Date | Oct 4, 2001 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. The long Fixion PF may also be used in mid shaft fractures, 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal. The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, revision procedures.
Device Story
Fixion PF is an expandable intramedullary nailing system for femoral fracture fixation. System includes a non-slotted stainless steel nail, femoral neck peg (hip peg), hip pin, and a single-use manual inflation pump. Surgeon inserts nail and hip peg into the medullary canal and femoral neck; uses manual pump to inject sterile inflation liquid, expanding the nail and peg to achieve secure fit against bone under X-ray guidance. Device provides mechanical stabilization of fractures. Used in clinical/surgical settings by orthopedic surgeons. Benefits include secure fixation via diameter expansion.
Clinical Evidence
Bench testing only. Mechanical performance evaluated via 4-point bending (ASTM F1264-99) and Hip Peg testing (ASTM F384-99).
Technological Characteristics
Constructed from 316L Stainless Steel (ASTM F138). Expandable cylindrical tube design. Actuated via manual hydraulic inflation pump. Sterilized and packaged per standard orthopedic implant practices. No software or electronic components.
Indications for Use
Indicated for patients with femur fractures, including shaft, proximal (stable/unstable pertrochanteric, intertrochanteric, subtrochanteric), and mid-shaft fractures. Also indicated for osteotomy, nonunions, malunions, bone reconstruction post-tumor resection, grafting, pathological fractures, and revision procedures.
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
- Fixion Interlocking PF Intramedullary Nailing System (K010988)
- Fixion Intramedullary Nailing System (K990717)
- Fixion Intramedullary Nailing System (K003212)
- Fixion Intramedullary Nailing System (K003215)
- Fixion Intramedullary Nailing System (K010901)
- Fixion Interlocking Intramedullary Nailing System (K002783)
- Proximal Femoral Nail (K970097)
Submission Summary (Full Text)
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# OCT - 4 2001
# 510(K) Summary
## Disc-O-Tech Medical Technologies, Ltd. Fixion Interlocking Proximal Femoral Intramedullary Nailing System
#### Company Name
Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzelia, 46728, Israel
#### Submitter's Name and Contact Person
Elad Magal Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzelia, 46728, Israel Tel: +972 9 9511511 Fax: +972 9 9548939
## Date Prepared
August 2001
#### Trade/Proprietary Name
Fixion™ Interlocking Proximal Femoral Intramedullary Nailing System (Fixion PF)
## Classification Name
Intramedullary Fixation Rod 21 CFR § 888.3020 Class II
## Predicate Devices
- 1. Fixion Interlocking PF Intramedullary Nailing System (K010988) by Disc-O-Tech
- 2. Fixion Intramedullary Nailing System (K990717, K003212, K003215, K010901) by Disc-O-Tech
- 3. Fixion Interlocking Intramedullary Nailing System (K002783) by Disc-O-Tech.
- 4. Proximal Femoral Nail (K970097) by Synthes.
## Performance Standards
The following standards were used:
- 1. The Fixion PF Nail is manufactured from 316L Stainless Steel, which meets the requirements of ASTM F138 - Standard Specification for Stainless steel Bar and Wire for Surgical Implants.
- 2. The Fixion PF Nailing System accessories incorporate surgical grade stainless steel and silicone.
- 3. The Fixion PF Nail is designed to meet the requirements of ASTM F565 Standard practice for Care and Handling of Orthopedic Implants and Instruments.
- 4. The 4 point bending mechanical testing was performed according to ASTM
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for Mechanical Performance Considerations for F1264-99 - - Standard Intramedullary Fixation Devices.
- 5. The Hip Peg testing was performed according to ASTM F384-99 Standard Specification for Metallic Angled Orthopedic Fracture Fixation Devices.
## Intended Use
The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures. The long Fixion PF may also be used in mid shaft fractures, 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal.
The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, revision procedures.
## System Description
The Fixion Intramedullary Proximal Femoral Nailing System consist of the following main components:
1. The Nail Implant is an expandable non-slotted stainless steel cylindrical tube, with a cap protected, female threaded proximal end with holes for Femoral Neck Peg (Hip Peg) and Hip Pin. Other implantable components provided are the Femoral Neck Peg (Hip Peg) and the Hip Pin.
2. The Instrument Set consists of a few accessories used during insertion and removal (if required) of the implant.
3. The Inflation Device (Pump) is a single-use manual plastic pump that is filled with sterile inflation liquid and used to expand the Nail implant and Femoral Neck (Hip) Peg
Once the Nail and the Femoral Neck Peg are positioned within the medullary canal and femur neck respectively, rotation of the pump handle allows for peg and nail diameter increase to their intended diameter under x-ray and controlled pressure. The Hip Pin may be inserted as well.
## Substantial Equivalence
The Fixion PF Nail is substantially equivalent to the Fixion PF Nail currently cleared for marketing under 510(k) K010988.
The modified Fixion PF Nail has the following similarities to that which previously received 510(k) concurrence:
- > Has the same intended use
- > Basically has the same operating principles
- > Basically incorporates the same design
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- 》 Incorporates the same materials and processes
- > Is sterilized and packed, basically, in the same manner.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines resembling a bird or a wing-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 4 2001
Mr. Elad Magal General Manager Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot Street Herzelia, 46728 Israel
Re: K012967
Trade/Device Name: Fixion™ Interlocking Proximal Femoral Intramedullary Nailing System Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 30, 2001 Received: September 4, 2001
Dear Mr. Magal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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#### Page 2 - Mr. Elad Magal
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Sincerely, yours,
L. Mark N. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indication for Use
510(K) Number (if known): k012967
Device Name: Fixion™ Interlocking Proximal Femoral Intramedullary Nailing System
#### Indication for Use:
The Fixion Interlocking Proximal Femoral Nailing System ("Fixion PF") is intended for The I chon intervociang 1 rouman estur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric Subtrochanterie (Mini timse fractures. The long Fixion PF may also be used in mid shaft fractures, 5cm below the surgical neck to 5cm proximal to the distal end of the medullar canal.
The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone The I baon 11 - b abound tumor resection, grafting and pathological fractures, revision procedures.
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# Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Page 22 of 27
for Mark N. Miller
and Neurological Device
CONFIDENTIAL-
510(k) Number.
