(9 days)
T2™ Recon Nail System
Not Found
No
The 510(k) summary describes a mechanical implant for fracture fixation and mentions material and design modifications. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
The device is for the treatment of fractures and diseases of the femur, but it is an orthopedic implant (nail system) used for fixation and stabilization rather than directly providing therapy.
No
The device, the S2TM Recon Nail System, is indicated for the fixation and stabilization of bone fractures. This is a therapeutic function, not a diagnostic one. The description focuses on its material and design for these purposes, and mentions "mechanical testing" to demonstrate "comparable mechanical properties," further supporting its function as a physical implant rather than a system designed to identify or determine the nature of a disease or condition.
No
The device description clearly states it is a "Nail System" and involves material and design modifications to a physical implant (femoral nail), indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for the fixation and stabilization of bone fractures in the femur. This is a surgical/implantable device, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a material and design modification of a surgical nail system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a physical implant used to treat a physical injury (fracture).
N/A
Intended Use / Indications for Use
The S2™ Recon Nail System indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Product codes
87 HSB
Device Description
This Special 510(k) submission is intended to address a material modification and a design modification of the T2™ Recon Nail System to create the subject device, which is referred to as the S2TM Recon Nail System. The material modification involves changing the material from Titanium alloy to Stainless Steel with design changes based on the S2™ Femoral and T2TM Recon Nails. There is no change in intended use for the modified device when compared to the previously cleared device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck to the supracondylar regions of the femur.
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)
Mcchanical testing demonstrated comparable mechanical properties to the predicate components and established substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
T2™ Recon Nail System
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
APR 1 3 2006
Summary of Safety and Effectiveness S2TM Recon Nail System
| Proprietary Name: | S2™ Recon Nail System |
|---|---|
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod |
| 21 CFR §888.3020 | |
| Device Product Code: | 87 HSB |
| For Information contact: | Francisco Haro, Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5493 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | March 31, 2006 |
Description:
This Special 510(k) submission is intended to address a material modification and a design modification of the T2™ Recon Nail System to create the subject device, which is referred to as the S2TM Recon Nail System. The material modification involves changing the material from Titanium alloy to Stainless Steel with design changes based on the S2™ Femoral and T2TM Recon Nails. There is no change in intended use for the modified device when compared to the previously cleared device.
Intended Use:
The subject S2TM Recon Nail System, like the predicate T2™ Recon Nail System, is a fracture fixation device comprised of femoral nails and related components. The subject and predicate devices are intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is used as an aid to healing, not as a substitute for normal intact bone and tissue. The indications for use provided below are exactly the same as the T2TM Recon Nail System's indications.
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Indications for Use:
The S2™ Recon Nail System indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Substantial Equivalence:
The subject S2™ Recon Nail System shares the same intended use, and basic design concepts as that of the currently available T2™ Recon Nail System. Mcchanical testing demonstrated comparable mechanical properties to the predicate components and established substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2006
Howmedica Osteonics Corporation c/o Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K060921
Trade/Device Name: S2™ Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 31, 2006 Received: April 4, 2006
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
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Page 2 - Mr. Francisco Haro
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. 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" (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,
elmale
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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bu921
510(k) Number (if known):
Device Name: S2TM Recon Nail System
Indications for Use:
The S2TM Recon Nail System indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence H, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices
Ko60921 510(k) Number_