(36 days)
Not Found
No
The summary describes a mechanical implant system for bone stabilization and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to "stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions," which are actions that treat or alleviate a disease or injury.
No
Explanation: The device is a system of nails and screws used to stabilize femoral fractures, impending pathologic fractures, non-unions, and malunions. Its intended use is mechanical stabilization and repair, not the detection, diagnosis, or monitoring of a disease or condition.
No
The device description explicitly states it is composed of physical components (cannulated femoral nails, solid locking screws, cannulated end caps), indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Synthes Adolescent Lateral Entry Femoral Nail System is a surgical implant used to stabilize bone fractures. It is directly implanted into the body and does not involve the analysis of biological specimens.
The provided information clearly describes a medical device used for orthopedic surgery, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Synthes Adolescent Lateral Entry Femoral Nail System will be intended to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions in adolescent and small stature adult patients.
Product codes
HSB
Device Description
Synthes Adolescent Lateral Entry Femoral Nail System is composed of cannulated femoral nails, solid 5.0 mm recon locking screws and cannulated end caps. Recon locking screws, as well as Synthes commercially available 4.0 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 fractures, ipsilateral neck/shaft fractures
Indicated Patient Age Range
adolescent and small stature adult patients
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)
Smith & Nephew's Adolescent Nail, Biomet's Pediatric Locking 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
Image /page/0/Picture/0 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. There is a registered trademark symbol next to the word "SYNTHES".
MAY -- 2 2007
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6940 | ||
| Contact: | Sheri L. Musgnung | |
| Synthes (USA) | ||
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6940 | ||
| Device Name: | Synthes Adolescent Lateral Entry Femoral Nail System | |
| Classification: | Class II, §888.3020 - Intramedullary fixation rod and accessories. | |
| Predicate Device: | Smith & Nephew's Adolescent Nail | |
| Biomet's Pediatric Locking Nail System | ||
| Device Description: | Synthes Adolescent Lateral Entry Femoral Nail System is | |
| composed of cannulated femoral nails, solid 5.0 mm recon locking | ||
| screws and cannulated end caps. Recon locking screws, as well as | ||
| Synthes commercially available 4.0 mm locking screws, are used to | ||
| secure the nail in the bone. | ||
| Intended Use: | Synthes Adolescent Lateral Entry Femoral Nail System will be | |
| intended to stabilize fractures of the femoral shaft, subtrochanteric | ||
| fractures, ipsilateral neck/shaft fractures, impending pathologic | ||
| fractures, non-unions and malunions in adolescent and small | ||
| stature adult patients. | ||
| Substantial | ||
| Equivalence: | Information presented supports substantial equivalence. |
1
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 stylized caduceus, which is a symbol of medicine, with three intertwined snakes and a staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2007
Synthes (USA) % Ms. Sheri L. Musgnung Sr. Regulatory Affair Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K070843
Trade/Device Name: Synthes Adolescent Lateral Entry Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 23, 2007 Received: March 27, 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 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Milke M Milkeron
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 logo that appears to be a stylized human figure inside of a circle. To the right of the word is a registered trademark symbol. A horizontal line runs underneath the word.
Indications for Use
510(k) Number (if known):
Device Name:
2.0
Synthes Adolescent Lateral Entry Femoral Nail System
Indications for Use:
Synthes Adolescent Lateral Entry Femoral Nail System will be intended to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, nonunions and malunions in adolescent and small stature adult patients.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
000004
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Off ce of Device Evaluation (ODE)
Mark M. Milkerss
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070843