(86 days)
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No
The device description focuses on the physical characteristics and intended use of a flexible nail for fracture stabilization, with no mention of AI or ML technology.
Yes
The device is intended for the temporary stabilization of bone segments or fragments until bone consolidation, which is a therapeutic purpose.
No
Explanation: The device is described as a "flexible nail designed to be curved so that the apex of the arc is located in the fracture site" for the "temporary stabilization of bone segments or fragments." This indicates it is a therapeutic device for fracture fixation, not a diagnostic device used to identify or characterize medical conditions.
No
The device description clearly states it is a "flexible nail" made of titanium alloy and stainless steel, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The T2™ Flexible Nail is an implantable device used for the mechanical stabilization of bone fractures. It is surgically inserted into the body and does not involve the analysis of biological specimens.
The description clearly indicates a surgical implant for orthopedic use, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The T2™ Flexible Nail is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. This includes upper extremity fractures of all patients and lower extremity fractures of pediatric or small-statured patients.
Specific indications include:
- Fixation of mid-diaphyseal, proximal and distal fractures of the femur, tibia, and . fibula in pediatric and small-statured patients.
- Fixation of mid-diaphyseal, proximal and distal fractures of humerus and forearm . fractures in all patients.
Product codes
HSB
Device Description
The T2™ Flexible Nail is a flexible nail designed to be curved so that the apex of the arc is located in the fracture site. It has a non-cannulated, one-piece, round shaft design that can be cut to size intraoperatively. The nail is available in eight diameters and two lengths. The nails will be available sterile and non-sterile in titanium alloy and stainless steel.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bone segments or fragments, upper extremity, lower extremity, mid-diaphyseal, proximal and distal fractures of the femur, tibia, and fibula, humerus and forearm
Indicated Patient Age Range
all patients, pediatric or small-statured patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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♡2018
510(k) Summary of Safety and Effectiveness OCT 1 0 2008 T2™ Flexible Nail
| Proprietary Name: | T2 ™ Flexible Nail |
|---|---|
| Common Name: | Intramedullary Nail |
| Classification Name/Reference: | Intramedullary Fixation Rod |
| 21 CFR §888.3020 | |
| Device Product Code: | 87 HSB |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Francisco Haro, Senior Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5493 Fax: (201) 831-6038 | |
| Date Summary Prepared: | July 15, 2008 |
Description:
The T2™ Flexible Nail is a flexible nail designed to be curved so that the apex of the arc is located in the fracture site. It has a non-cannulated, one-piece, round shaft design that can be cut to size intraoperatively. The nail is available in eight diameters and two lengths. The nails will be available sterile and non-sterile in titanium alloy and stainless steel.
Indications:
The T2™ Flexible Nail is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. This includes upper extremity fractures of all patients and lower extremity fractures of pediatric or small-statured patients. Specific indications include:
- . Fixation of mid-diaphyseal, proximal and distal fractures of the femur, tibia, and fibula in pediatric and small-statured patients.
- Fixation of mid-diaphyseal, proximal and distal fractures of humerus and forearm fractures in all patients.
Substantial Equivalence:
The subject system is substantially equivalent to the predicate nailing systems for the stabilization of long bone fractures using a closed technique. The supporting information included in the following pages has sufficiently demonstrated the equivalence of the subject device to its predicates in regards to intended use, design, materials and operational principles.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2008
Howmedica Osteonics Corp. c/o Mr. Francisco Haro Regulatory Affairs Associate 325 Corporate Drive Mahwah, NJ 07430
Re: K082018
Trade/Device Name: T2TM Flexible Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: July 15, 2008 Received: July 16, 2008
Dear Mr. Haro:
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.
2
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K082018
Device Name: T2™ Flexible Nail
Indications for Use:
The T2™ Flexible Nail is intended for the temporary stabilization of bone segments or fragments until bone consolidation has been achieved. This includes upper extremity fractures of all patients and lower extremity fractures of pediatric or small-statured patients.
Specific indications include:
- Fixation of mid-diaphyseal, proximal and distal fractures of the femur, tibia, and . fibula in pediatric and small-statured patients.
- Fixation of mid-diaphyseal, proximal and distal fractures of humerus and forearm . fractures in all patients.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| Page 1 of 1 | |
|---|---|
| 510(k) Number | K082018 |