(12 days)
Not Found
No
The summary describes a mechanical implant system for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
This device is an implant used for fixation of fractures, not a therapeutic device designed to cure or treat a disease or condition in an active manner.
No
The device, the Synthes Elastic Intramedullary Nail (EIN) System and End Cap, is described as being used for the fixation of fractures, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a physical implant (Elastic Intramedullary Nail and End Cap) used for fracture fixation, not a software application.
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 description and intended use of the Synthes Elastic Intramedullary Nail (EIN) System clearly indicate it is an implantable surgical device used for the fixation of bone fractures. It is physically inserted into the body to stabilize bones.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition based on biological samples.
Therefore, based on the provided information, the Synthes Elastic Intramedullary Nail (EIN) System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
Product codes
HSB
Device Description
The Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the Synthes Elastic Intramedullary Nail (EIN) System. The end cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
diaphyseal fractures, upper extremity, lower extremity, metaphyseal and epiphyseal fractures, radial neck, small long bones, carpal and tarsal bones
Indicated Patient Age Range
all patients, pediatric or small-stature patients, pediatric applications
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)
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.
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Image /page/0/Picture/1 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 line underneath the word "SYNTHES" and the logo. There is a registered trademark symbol to the right of the word.
AUG 11 2008
:
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6538 | ||
| Device Name: | Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, Line | |
| Extension | ||
| Classification: | 21 CFR 888.3020: Intramedullary fixation rod (HSB) | |
| Predicate Devices: | Synthes Stainless Steel Elastic Intramedullary Nail (EIN) System | |
| (K081452) | ||
| Synthes Elastic Intramedullary Nail (EIN) End Cap (K053105) | ||
| Device Description: | The Synthes Elastic Intramedullary Nail (EIN) End Cap is used | |
| with the Synthes Elastic Intramedullary Nail (EIN) System. The | ||
| end cap is inserted over the external portion of the nail and | ||
| threaded into the cancellous bone in an oblique orientation. | ||
| Intended Use: | The Synthes Elastic Intramedullary Nail (EIN) System is indicated | |
| for fixation of diaphyseal fractures where the canal is narrow or | ||
| flexibility of the implant is paramount. This includes upper | ||
| extremity fractures in all patients and lower extremity fractures in | ||
| pediatric or small-stature patients. This system is also intended to | ||
| treat metaphyseal and epiphyseal fractures, such as radial neck | ||
| fractures and is intended for fixation of small long bones, such as | ||
| carpal and tarsal bones. In pediatric applications, the flexibility of | ||
| the EIN allows it to be inserted at a point which avoids disruption | ||
| to the bone growth plate. | ||
| Substantial | ||
| Equivalence: | Information presented supports substantial equivalence. |
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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 an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2008
Synthes (USA) % Ms. Jill R. Sherman Regulatory Affairs/Compliance Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Rc: K082148
Trade/Device Name: Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 29, 2008 Received: July 30, 2008
Dear Ms. Sherman:
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. Jill R. Sherman
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 the reporting 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 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 W. Milliman
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. To the right of the word is a small circle with a registered trademark symbol inside. There is a horizontal line underneath the word.
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Indications for Use
510(k) Number (if known):
KO82148
Device Name:
2.0
Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, Line Extension
Indications for Use:
The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Mark Concurrence of DRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K08