(77 days)
No
The summary describes a mechanical locking system for intramedullary nails, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is a component of a locking system for intramedullary nails, used to achieve angular and axial stable locking, rather than directly treating a disease or condition.
No
The device description indicates that the Synthes Angular Stable Locking System (ASLS) is a component designed for use with intramedullary nails to provide angular and axial stable locking, functioning as an alternative device for interlocking. Its purpose is to provide structural stability, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the device consists of a titanium screw with a premounted peek sleeve, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used with Synthes Titanium Intramedullary Nails to achieve angular and axial stable locking. This describes a surgical implant used within the body to stabilize fractures.
- Device Description: The description details a titanium screw with a peek sleeve, available in various sizes. This is consistent with a medical device used in orthopedic surgery.
- 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.
IVD devices are used outside the body to analyze biological samples. This device is clearly intended for internal use during surgery.
N/A
Intended Use / Indications for Use
Synthes Angular Stable Locking System (ASLS) is indicated for use with Synthes Titanium Intramedullary Nails to achieve angular and axial stable locking.
Product codes
HSB
Device Description
Synthes Angular Stable Locking System (ASLS) is designed as an alternative device for interlocking Synthes Titanium Intramedullary Nails. The ASLS consists of a titanium screw with a premounted peek sleeve and is available in diameters ranging between 4.0 mm - 6.0 mm and overall lengths ranging between 26 mm - 125 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
To be inferred from context: Synthes 3.9 mm Ti Locking Bolts, Synthes 4.9 mm Ti Locking Bolts, Synthes 6.0 mm Locking Screws (K061910)
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, a medical device company. Next to the logo is the handwritten word "Koblalo". There is a long line underneath the logo and the handwritten word.
3.0
Ko6lqlo
| 510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | Synthes (USA) |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6940 | |
| SEP 2 1 2006 | |
| Device Name: | Synthes Angular Stable Locking System (ASLS) |
| Classification: | Class II, §888.3020 - Intramedullary fixation rod. |
| Predicate Device: | Synthes 3.9 mm Ti Locking Bolts |
| Synthes 4.9 mm Ti Locking Bolts | |
| Synthes 6.0 mm Locking Screws | |
| Device Description: | Synthes Angular Stable Locking System (ASLS) is designed as an |
| alternative device for interlocking Synthes Titanium Intramedullary | |
| Nails. The ASLS consists of a titanium screw with a premounted | |
| peek sleeve and is available in diameters ranging between 4.0 mm |
- 6.0 mm and overall lengths ranging between 26 mm - 125 mm. |
| Intended Use: | Synthes Angular Stable Locking System (ASLS) is indicated for
use with Synthes Titanium Intramedullary Nails to achieve angular
and axial stable locking. |
| Substantial
Equivalence: | Information presented supports substantial equivalence. |
000005
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Sheri L. Musgnung Sr. Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
SEP 2 1 2006
Re: K061910
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 5, 2006 Received: July 6, 2006
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) 276-0210 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,
Mark A. Millerson
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, with a registered trademark symbol next to it. To the left of the word is a logo consisting of a circle with a design inside. To the right of the word is a handwritten word, possibly a signature or annotation, in black ink.
| 2.0 | Indications for Use |
|---|---|
| 510(k) Number (if known): | |
| Device Name: | Synthes Angular Stable Locking System (ASLS) |
| Indications for Use: | Synthes Angular Stable Locking System (ASLS) is indicated for use with Synthes Titanium Intramedullary Nails to achieve angular and axial stable locking. |
| Prescription Use | |
| (Per 21 CFR 801.109) | X |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mullen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
000004