(29 days)
Not Available
Not Found
No
The summary describes a mechanical implant system for fracture fixation and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
Yes
The device is intended to treat fractures of the proximal femur, which is a therapeutic purpose.
No
Explanation: The device described is a surgical implant (nail, helical blade, end cap) used for treating bone fractures, not for diagnosing medical conditions.
No
The device description explicitly lists physical components (cannulated femoral nail, cannulated helical blade, cannulated nail end cap) which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device description and intended use: The provided text describes a surgical implant (a nail and related components) used to fix bone fractures in the proximal femur. This is a device used within the body for structural support and healing, not for testing samples outside the body.
The information clearly indicates a device used for surgical intervention, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HWC
Device Description
Synthes TFN System consists of a cannulated femoral nail, a cannulated helical blade and a cannulated nail end cap. Synthes Helical Blades will be available in three additional lengths, 75 mm, 125 mm, and 130 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, trochanteric and diaphyseal regions
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.
Synthes Trochanteric Fixation Nail (TFN) System
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.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present underneath the word. The "®" symbol is located to the right of the word.
..
Ko70294
MAR 0 1 2007
| 3.0 | 510(k) Summary | Page 1 of 1 | |
|---|---|---|---|
| Sponsor: | Synthes (USA) | ||
| 130 Goshen Parkway | |||
| West Chester, PA 19380 | |||
| (610) 719-6940 | |||
| Device Name: | Synthes Trochanteric Fixation Nail (TFN) System, additional | ||
| Helical Blades | |||
| Classification: | 21 CFR 888.3020: Rod, Fixation, Intramedullary and Accessories | ||
| Predicate Devices: | Synthes Trochanteric Fixation Nail (TFN) System | ||
| Device Description: | Synthes TFN System consists of a cannulated femoral nail, a | ||
| cannulated helical blade and a cannulated nail end cap. Synthes | |||
| Helical Blades will be available in three additional lengths, 75 mm, | |||
| 125 mm, and 130 mm. | |||
| Intended Use: | Synthes Trochanteric Fixation Nail (TFN) System is intended to | ||
| treat stable and unstable fractures of the proximal femur including | |||
| pertrochanteric fractures, intertrochanteric fractures, basal neck | |||
| fractures, and combinations thereof. The Long TFN is additionally | |||
| indicated for subtrochanteric fractures, pertrochanteric fractures | |||
| associated with shaft fractures, pathologic fractures (including | |||
| prophylactic use) in both trochanteric and diaphyseal regions, long | |||
| subtrochanteric fractures, proximal or distal non-unions, | |||
| malunions, and revisions. | |||
| Substantial | |||
| Equivalence: | Information presented supports substantial equivalence. |
:
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
MAR C 1 2007
Re: K070294
Trade/Device Name: Synthes Trochanteric Fixation Nail (TFN) system, additional helical blades Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: January 30, 2007 Received: January 31, 2007
Dear Ms. Musgnung:
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
2
Page 2 - Ms. Sheri L. Musgnung
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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark Al-Mulla
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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a horizontal line underneath the word "SYNTHES" and the logo. The "®" symbol is located to the right of the word.
K070294
page 1 of
2.0
Indications for Use
702
Helical Blades
revisions.
510(k) Number (if known):
Device Name:
Indications for Use:
Mark H. Millikan
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number
X Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Synthes Trochanteric Fixation Nail (TFN) System, Additional
Synthes Trochanteric Fixation Nail (TFN) System is intended to
treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN
is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and
No
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)