(17 days)
Not Found
Not Found
No
The summary describes a mechanical fracture fixation device and makes no mention of AI or ML technology.
Yes
The device is described as aiding in the healing of femoral fractures, which is a therapeutic function.
No
Explanation: The device description clearly states it is a "fracture fixation device" and "aid to healing", not a diagnostic tool. Its intended use is for physical stabilization of femoral fractures.
No
The device description clearly states it is a "fracture fixation device comprised of Femoral Nails and associated instruments, Locking Screws, Set Screws, End Caps, and Lag Screws," which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a fracture fixation device for various types 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, screws, and other components used for internal fracture fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVDs are used to perform tests outside the body on biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The subject T2 " Recon Nail System is a fracture fixation device comprised of Femoral Nails and 1116 subject 1 = 1 coon Prashers, Locking Screws, Set Screws, End Caps, and Lag Screws. the subject and predicate devices are intended to provide strong and stable internal fracture The subjour and product 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 necks shart, communitied promotary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Product codes (comma separated list FDA assigned to the subject device)
87 HSB
Device Description
The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This The 12 Tecon Fran Bystein is a line extension to the T2® Recon Nail System to add an alternate Special 210(x) submission is a there is no change in intended use for the subject device, which is provided below.
The subject T2 " Recon Nail System is a fracture fixation device comprised of Femoral Nails and 1116 subject 1 = 1 coon Prashers, Locking Screws, Set Screws, End Caps, and Lag Screws. the subject and predicate devices are intended to provide strong and stable internal fracture The subjour and product tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral shaft
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 subject as rios is normanical testing demonstrates the comparable mechanical properties of the subject T2® Recon Nail System to the predicate device.
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.
Not Found
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
T2® Recon Line Extension
510(k) Summary of Safety and Effectiveness: T2® Recon Nail System Line Extension
JUL 7 - 2005
| Submission Information | |
|---|---|
| Name and Address of the Sponsor | |
| of the 510(k) Submission: | Howmedica Osteonics Corp |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5581 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | June 17, 2005 |
| Device Identification | |
| Proprietary Name: | T2® Recon Nail System |
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod and Accessories |
| 21 CFR §888.3020 | |
| Device Product Code: | 87 HSB |
Description:
Description.
The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This The 12 Tecon Fran Bystein is a line extension to the T2® Recon Nail System to add an alternate Special 210(x) submission is a there is no change in intended use for the subject device, which is provided below.
Intended Use:
The subject T2 " Recon Nail System is a fracture fixation device comprised of Femoral Nails and 1116 subject 1 = 1 coon Prashers, Locking Screws, Set Screws, End Caps, and Lag Screws. the subject and predicate devices are intended to provide strong and stable internal fracture The subjour and product 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 necks shart, communitied promotary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Statement of Technological Comparison:
Statement of Technological Obligation alloy and PEEK while the predicate device is made The subject as rios is normanical testing demonstrates the comparable mechanical properties of the subject T2® Recon Nail System to the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 7 - 2005
Ms. Vivian Kelley, RAC Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey USA 07430
Re: K051624
Trade/Device Name: T2® Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 17, 2005 Received: June 20, 2005
Dear Ms. Kelley:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to regary the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that ao novice, subject to the general controls provisions of the Act. The Tou may, merelore, market the act include requirements for annual registration, listing of general controll provision 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 your device is elassified (600 acal controls. Existing major regulations affecting your device It may be sugled to Sach addiness Regulations, Title 21, Parts 800 to 898. In addition, FDA can oc found in the overants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean F least of advised that I DTC issualite of your device complies with other requirements of the Act that I DT has intace and regulations administered by other Federal agencies. You must of any I catelli stututes and registments, including, but not limited to: registration and listing (21 Comply with an the Net 8 requirements) and manufacturing practice requirements as set CI I rull 6077, idoomig (21 cegulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by over of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Vivian Kelley, RAC
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin manxemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale website premarket notification. "The PDT Intamge of cassement of the spermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ace at (240) 276-0120 . Also, please note the regulation entitled, comaci the Office of Comphalled at (210) 276 or art 807.97). You may obtain "Misbranding by relefence to premarket noulification of Set from the Division of Small
other general information on your responsibilities under the Act from work on 6800 638, other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or and index html Manufacturers, International and Consulter Pibelows of the many of the many in the samm
Sincerely yours,
Stupt hurla
Miriam C. Provost, Ph.D. Acting 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): K
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 _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(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
Stypt Clurke
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________