(21 days)
Not Found
No
The provided text describes an intramedullary nailing system for fracture fixation and does not mention any AI or ML components.
Yes
The device is indicated for treating fractures, nonunions, malunions, and enabling bone reconstruction, which are all therapeutic interventions aimed at restoring health or function.
No
Explanation: The "Intended Use / Indications for Use" section describes the devices for treating fractures and other bone conditions, rather than for diagnosing them. The device is used for fixation and reconstruction, which are therapeutic interventions.
No
The intended use describes devices for fixing bone fractures in the femur, tibia, and humerus. The predicate devices listed are all intramedullary nailing systems, which are physical implants and associated surgical tools. There is no mention of software in the provided text.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's purpose as fixing fractures and performing procedures on bones (femur, tibia, humerus). This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information related to sample analysis, diagnostic metrics (sensitivity, specificity, etc.), or any mention of analyzing biological samples further supports that this is not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used directly on the body for structural support and repair.
N/A
Intended Use / Indications for Use
Femur:
- fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures;
- proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
- use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur;
- mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- comminuted shaft fractures; -
- fixation of short distal or proximal fragments -
Tibia:
- diaphyseal shaft fractures in the tibia; -
- comminuted shaft fractures; -
- fixation of short distal or proximal fragments -
Humerus:
- diaphyseal shaft fractures in the humerus;
- comminuted shaft fractures: ー
- fixation of short distal or proximal fragments -
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Tibia, Humerus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K990717, K003215, K003215, K010901, K021324, K023437, K002783, K013449, K023437, K010988, K012967, K023437, K914453, K914371
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 1 2 2003
Disc-O-Tech Medical Technologies, Ltd. Fixion Intramedullary Nailing Systems
32588
page 1 of 3
510(K) Summary
Disc-O-Tech Medical Technologies, Ltd.
Fixion® Intramedullary Nailing System; Fixion® Interlocking Intramedullary Nailing System; Fixion Interlocking Proximal Femoral Intramedullary Nailing System
Company Name
Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzliya Israel, 46728
Submitter's Name and Contact Person
Yael Rubin Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzliya Israel, 46728 Tel: +972 9 9511511 Fax: +972 9 9548939
Date Prepared
August 2003
Trade/Proprietary Name
Fixion® Intramedullary Nailing System; Fixion® Interlocking Intramedullary Nailing System; Fixion® Interlocking Proximal Femoral Intramedullary Nailing System;
Classification Name
Intramedullary Fixation Rod 21 CFR § 888.3020 Class II
Predicate Devices
- Fixion Intramedullary Nailing System (K990717, K003215, K003215, K010901, l . K021324, K023437) by Disc-O-Tech.
- Fixion Interlocking Intramedullary Nailing System (K002783, K013449, K023437) 2.
1
by Disc-O-Tech.
- Fixion Interlocking Proximal Femoral Intramedullary Nailing System (K010988, 3. K012967, K023437) by Disc-O-Tech.
- Unreamed Tibial Nail (K914453), by Synthes. 4.
- Universal Femoral Nail (K914371), by Synthes. న్.
Performance Standards
The following standards were used:
- The Fixion Intramedullary Nailing Systems Nails and Hip Peg are manufactured 1. from Stainless Steel, which meets the requirements of ASTM F 138 (UNS31673)/ ISO 5832-1, and from Stainless Steel, which meets the requirements of ASTM F 1314 (UNS S20910).
- The Fixion Intramedullary Nailing Systems are designed to meet the requirements of 2. ASTM F 565 - Standard Practice for Care and Handling of Orthopedic Implants and Instruments.
Intended Use
Femur:
- V fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures:
- イ fractures including stable and unstable pertrochanteric, proximal femoral intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures:
- V use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur:
- イ mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- く comminuted shaft fractures:
- イ fixation of short distal or proximal fragments
Tibia:
-
diaphyseal shaft fractures in the tibia;
- V comminuted shaft fractures;
-
fixation of short distal or proximal fragments
2
Humerus:
- diaphyseal shaft fractures in the humerus; V
- イ comminuted shaft fractures;
- イ fixation of short distal or proximal fragments
Substantial Equivalence
The modified Fixion Intramedullary Nailing Systems have the following similarities to those that previously received 510(k) concurrence:
- Have the same intended use V
- イ Have the same operating principles
- イ Incorporate the same design principles
- V Incorporate either the same or similar materials
- イ Have the same packaging and undergo the same sterilization processes, using the same materials and processes.
3
Image /page/3/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. The bottom half of the circle contains a stylized image of what appears to be an abstract symbol, possibly representing a human figure or a stylized bird.
SEP 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Yael Rubin Director of Regulatory Affairs Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya, Israel 46728
Re: K032588
Trade/Device Names: Fixion® Intramedullary Nailing System,
Fixion® Interlocking Intramedullary Nailing System, Fixion® Interlocking Proximal Femoral Inramedullary Nailing System
Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 20, 2003 Received: August 22, 2003
Dear Mr. Rubin:
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.
4
Page 2 - Mr. Yael Rubin
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.
Muriam C. Provost
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
5
Indication for Use
510(K) Number (if known): _ 1030588
Device Name:
Fixion® Intramedullary Nailing System Fixion® Interlocking Intramedullary Nailing System Fixion® Interlocking Proximal Femoral Intramedullary Nailing System
Indication for Use: These devices are indicated for the following:
Femur:
- fractures in the femur shaft, proximal femoral fractures, and combinations of these । fractures;
- proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
- use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur;
- mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- comminuted shaft fractures; -
- fixation of short distal or proximal fragments -
Tibia:
- diaphyseal shaft fractures in the tibia; -
- comminuted shaft fractures; -
- fixation of short distal or proximal fragments -
Humerus:
- diaphyseal shaft fractures in the humerus;
- comminuted shaft fractures: ー
- fixation of short distal or proximal fragments -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over the Counter Use | |
|---|---|---|---|---|
| (per 21 CFR 801.109) |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| Page 22 of 27 | 510(k) Number | K032588 |
|---|---|---|
| --------------- | --------------- | --------- |