(61 days)
Not Found
Not Found
No
The summary describes a mechanical implant system for bone stabilization and does not mention any software, image processing, or AI/ML terms.
Yes
The device is intended to stabilize fractures and treat non-unions and malunions, which are therapeutic medical purposes.
No
The device is described as a system for stabilizing femoral fractures, indicating a therapeutic or surgical purpose rather than a diagnostic one. There is no mention of it being used to identify or characterize a disease or condition.
No
The device description explicitly states it is composed of physical components like cannulated femoral nails, solid locking screws, and cannulated end caps, 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Synthes Lateral Entry Femoral Nail System is a surgical implant designed to stabilize bone fractures. It is physically inserted into the body.
- Intended Use: The intended use is to treat bone fractures, which is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant for orthopedic use, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
Synthes Lateral Entry Femoral Nail System is composed of cannulated femoral nails, solid 6.5 mm recon locking screws and cannulated end caps. Recon locking screws, as well as Synthes commercially available 5.0 mm and 6.0 mm locking screws, are used to secure the nail in the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral shaft, subtrochanteric, neck/shaft (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)
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 Ti Cannulated Femoral Nail, Smith & Nephew TriGen Antegrade Femoral Nail and DePuy ACE ART Femoral Nail.
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
APR 1 2 2004
:
040336
page 1 of 1
-
- 510(k) Summary:
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sheri L. Musgnung |
| Device Name: | Synthes (USA) Lateral Entry Femoral Nail System |
| Device Classification: | 21 CFR 888.3020 -- "Intramedullary fixation rod"
21 CFR 888.3040 -- "Smooth or threaded metallic bone
fixation fastener" |
| Predicate Device: | Synthes Ti Cannulated Femoral Nail, Smith & Nephew TriGen
Antegrade Femoral Nail and DePuy ACE ART Femoral Nail. |
| Description of Device: | Synthes Lateral Entry Femoral Nail System is composed of
cannulated femoral nails, solid 6.5 mm recon locking screws and
cannulated end caps. Recon locking screws, as well as Synthes
commercially available 5.0 mm and 6.0 mm locking screws, are used
to secure the nail in the bone. |
| Indications: | Synthes Lateral Entry Femoral Nail System is intended to stabilize
femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft
fractures, impending pathologic fractures, non-unions and malunions. |
| Material: | Titanium alloy |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes
Lateral Entry Femoral Nail System is substantially equivalent* to
other legally marketed devices. |
| | * The term "substantially equivalent" as used in this 510(k) notification is
limited to the definition of substantial equivalence found in the Food, Drug,
and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E,
under which a device can be marketed without pre-market approval or
reclassification. A determination of substantial equivalency under this
notification is not intended to have any bearing whatsoever on the resolution
of patent infringement suits or any other patent matter. No statements related
to, or in support of substantial equivalence herein shall be construed as an
admission against interest under the US Patent Laws or their application by the
courts. |
1000 - 1000
:
CONFIDENTIAL
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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, black silhouette.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli. Pennsylvania 19301
Re: K040336
Trade/Device Name: Synthes (USA) Lateral Entry Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 10, 2004 Received: February 11, 2004
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 enclosurc) 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. Sheri L. Musgnung
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 (301) 594-4659. 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,
Mark A Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2. Indications for Use
Page of
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes (USA) Lateral Entry Femoral Nail System
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
Mark A. Millerson
n of General, Restorative, and Neurological Devices
CONFIDENTIAL
510(k) Number K040336
0004
Premarket Notification 510(k) Synthes I ateral Entry Femoral Nail System