(90 days)
Not Found
No
The description details a mechanical system for fixing bone fractures and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is intended for the fixation of long bone fractures, which is a therapeutic purpose.
No
The device is an intramedullary nailing system intended for the fixation of long bone fractures, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components (Nail implant, Driver, Inflation device) made of materials like stainless steel and plastic, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Fixion Nail Function: The Fixion Intramedullary Nailing System is an implantable device used to fix bone fractures. It is surgically inserted into the bone and expanded to stabilize the fracture.
- Lack of Sample Testing: The description of the Fixion Nail does not involve any testing of samples taken from the body. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Fixion Intramedullary Nailing System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Fixion™ Intramedullary Nailing System ("Fixion™ Nail") is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, femur and the tibia. It is indicated for use in shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.
Product codes
HSB
Device Description
The Fixion™ Intramedullary Nailing System is a single use system that features 3 main components: Nail implant, Driver, and Inflation device.
- The Nail implant is an expandable non-slotted stainless steel cylindrical tube, with a conical shaped distal end and a cap protected, female threaded proximal end.
- The Driver is a stainless steel cylinder with plastic handle. used for the nail insertion, location and adjustment at the intramedullary canal. In addition, it serves as a delivery system for the inflation liquid. The Driver has a male threaded end to be connected to the Nail implant proximal end. A quick connector is located on the Driver to be connected to the Inflation device.
- The Inflation device is a single use manual plastic "pump", filled with sterile inflation liquid, similar to a PTCA inflation pump but with higher pressure. The inflation device outlet pipe end has a female quick connector to be connected to the Driver connector. Once the nail is positioned within the medullary canal, rotation of the "pump" handle allows for nail diameter increase to its intended diameter under X-ray and controlled pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Long bone fractures, diaphyseal fractures in the humerus, femur and the tibia. Shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the Fixion™ Nail have been tested and approved through a series of in-vitro and animal studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K803106, K883882, K924004, K925544, K931256, K914453, K914371, K933518, K932330, K923580
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
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.(b)
Classification. Class II.
0
K 99 0 717
7.1
510(K) Summary
Disc-O-Tech Medical Technologies Fixion Intramedullary Nailing System
Company Name
Disc-O-Tech Medical Technologies, Inc. 3 Hasadnaot St. Herzlia Israel, 46728
Submitter's Name and Contact Person
Jonathan S. Kahan, Esq. 555 Thirteenth Street, N.W. Washington, DC 20004 Tel: 202-637-5794 Fax: 202-637-5910
Date Prepared
February, 1999.
Trade/Proprietary Name
Fixion™ Intramedullary Nailing System
Classification Name
Intramedullary Fixation Rod 21 C.F.R. § 888.3020 Class II
3 1999
JUN
1
Predicate Devices
- · CINTOR Orthopedic Div's Aginsky Nail (K803106
- · HOWMEDICA's Seidel Humeral Locking Nail (K883882, K924004, K925544, K931256)
- SYNTHES's AO Universal Tibial and Femoral Nails (K914453, and K914371
- · SYNTHES's AO Unreamed Humeral (UHN) Tibial (TNN) and Femoral (UFN) Nails (K933518, K932330, and K923580, respectively).
Performance Standards
No performance standards applicable to Intramedullary Nails have been established by the FDA. However, the following standards were used:
- · Stainless steel 316L which is used to manufacture the Fixion™ Intramedullary Nailing System meets the requirements of ASTM F138 - Standard Specification for Stainless steel Bar and Wire for Surgical Implants.
- · The 4 point bending mechanical testing was performed according to ASTM F 1264 - standard for mechanical performance considerations for intramedullary fixation devices.
- · The torsional mechanical testing was performed according to ASTM F383 -Standard Practice for Static Bend and Torsion Testing of Intramedullary Rods.
Intended Use
The Fixion"M Intramedullary Nailing System ("Fixion" Nail") is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, femur and the tibia. It is indicated for use in shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.
2
System Description
The Fixion™ Intramedullary Nailing System is a single use system that features 3 main components: Nail implant, Driver, and Inflation device.
- · The Nail implant is an expandable non-slotted stainless steel cylindrical tube, with a conical shaped distal end and a cap protected, female threaded proximal end.
- · The Driver is a stainless steel cylinder with plastic handle. used for the nail insertion, location and adjustment at the intramedullary canal. In addition, it serves as a delivery system for the inflation liquid.
The Driver has a male threaded end to be connected to the Nail implant proximal end. A quick connector is located on the Driver to be connected to the Inflation device.
- · The Inflation device is a single use manual plastic "pump", filled with sterile inflation liquid, similar to a PTCA inflation pump but with higher pressure. The inflation device outlet pipe end has a female quick connector to be connected to the Driver connector.
Once the nail is positioned within the medullary canal, rotation of the "pump" handle allows for nail diameter increase to its intended diameter under X-ray and controlled pressure.
Substantial Equivalence
The Fixion™ Nail has the same intended use and substantially similar indications for use as the predicates, i.e., fixation of long bone fractures of the humerus, tibia, and femur.
The performance characteristics of the Fixion Nail have been tested and approved through a series of in-vitro and animal studies.
The Fixion™ Nail, like the Synthes Universal Tibial and Femoral Nails, is a Stainless Steel 316L canulated design. The cross section of the Fixion™ Nail is circular with reinforcement bars, which was found to be equivalent in mechanical properties to the circular cross section of the predicate devices.
With respect to fixation, the expansion of the Fixion™ Nail results in the attachment of the 4 reinforcement bars to the medullary canal wall, providing equivalent fixation to the distal mechanism of the Seidel Humeral locking nail, in which the nail distal end's three leaves are expanded and attached to the medullar canal wall.
The expansion of the Fixion nail with saline, which is a non-compressible biocompatible fluid, does not raise any safety concerns.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
2 1999 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jonathan s. Kahan, Esq. Hogan & Hartson, L.L.P. Representing Disc-O-Tech Medical Technologies, Inc. 555 Thirteenth Street, N.W. Washington, DC 20004
Re: к990717 Fixion™ Intramedullary Nail System Trade Name: Regulatory Class: II Product Code: HSB Dated: February 24, 1 ਰੇ ਰੇ ਰੋ March 4, 1999 Received:
Dear Mr. Kahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in 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.
4
Page 2 - Jonathan s. Kahan, Esq.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 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 ene regaration chosers. (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 (800) 638-2041 or (301) 443-6597 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
Enclosure
5
INDICATION FOR USE
K990717 510(K) Number (if known): _
Device Name:
Fixion™ Intramedullary Nailing system
Indication for Use:
The Fixion™ Intramedullary Nailing system is intended for use in the fixation of long bone fractures, including diaphyseal fractures in the humerus, femur and the tibia. It is indicated for use in shaft fractures 5cm below the surgical neck to 5cm proximal to the distal end of the medullary canal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Ofice of Device Evaluation (ODE) (Division Sign-off) Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
510(k) Number:
Prescription Use (per 21 CFR 801.109)
OR
Over the Counter
Use
livision of General Restorative De