(28 days)
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No
The summary describes a mechanical fracture fixation device and its accessories, with no mention of software, algorithms, or any technology related to AI or ML. The submission is a line extension for a mechanical component.
Yes
Explanation: The device is intended to provide internal fracture fixation and is utilized as an aid to healing, which are therapeutic functions.
No
Explanation: The device is described as a "fracture fixation device" and its purpose is to "provide strong and stable internal fracture fixation." It is used to aid healing, not to diagnose a condition.
No
The device description explicitly states it is a "fracture fixation device comprised of Femoral Nails and the related accessories such as Washers, Locking Screws, Set Screws, End Caps, and Lag Screws," which are all physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "fracture fixation device" used for "internal fracture fixation" of femoral fractures. This is a surgical implant used in vivo (within the body) to stabilize bone.
- Device Description: The description reinforces that it's a system of "IM Nails" (intramedullary nails) for femoral fractures.
- 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. This device does not perform any such tests.
The T2® Recon Nail System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The subject 120 Recon Nail System is a fracture fixation device comprised of Femoral Nails and the related accessories such as Washers, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The T2® Recon Nail 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
HSB
Device Description
The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This Special 510(k) submission is a line extension to the T2® Recon Nail System to add an alternate design of Set Screw to the system. There is no change in intended use for the subject device, which is provided below.
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
femoral shaft, femoral neck, 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
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Description of the test set, sample size, data source, and annotation protocol
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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)
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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
DEC 1 8 2008
Special 510(k)
/ .
510(k) Summary of Safety and Effectiveness: T2® Recon Nail System Line Extension
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
For Information contact:
Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430
Avital Merl-Margulies, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6365 Fax: (201) 831-6038
Date Summary Prepared:
November 10, 2008
Device Identification
Proprietary Name: Common Name: Classification Name and Reference: T2® Recon Nail System Intramedullary Nail Intramedullary Fixation Rod and Accessories, 21 CFR §888.3020 87 HSB
Device Product Codc:
Description:
The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This Special 510(k) submission is a line extension to the T2® Recon Nail System to add an alternate design of Set Screw to the system. There is no change in intended use for the subject device, which is provided below.
Intended Use:
The subject 120 Recon Nail System is a fracture fixation device comprised of Femoral Nails and the related accessories such as Washers, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
Indications for Use:
The T2® Recon Nail 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.
Statement of Technological Comparison:
The subject and prodicate devices are made from titanium alloy and PEEK. Functional and mechanical testing demonstrates the comparable mechanical & functional propertics of the subject T2® Recon Nail System to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2008
Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies 325 Corporate Drive Mahwah, NJ 07430
Re: K083437
Trade/Device Name: 120 Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 10, 2008 Received: November 20, 2008
Dear Ms. Merl-Margulies:
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
Page 2 -- Ms. Avital Merl-Margulies
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark H. Milliken
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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Indications for Use
510(k) Number (if known): K083437
Device Name: T2® Recon Nail System
Indications For Use:
The T2® Recon Nail 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 (Part 21 CFR 801 Subpart D)
AND/OR
(21 CFR 807 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
ign-01 Division of General, Restorative, and Neurological Devices
10683432
510(k) Number.