(84 days)
Not Found
Not Found
No
The summary describes a system of plates and screws for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions, which are structural and mechanical functions, not therapeutic.
No
The device is described as a system for fixation of bones and fragments, indicating it is an orthopedic implant for treatment, not diagnosis. The "Intended Use" section clearly states its purpose is for "fixation," which is a therapeutic action.
No
The device description explicitly states it consists of physical components like plates and screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the fixation of small bones and fragments, osteotomies, arthrodeses, replantations, and reconstructions. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as a system of plates and screws, which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
Synthes 1.5mm Mini Fragment LCP System is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments, particularly in osteopenic bone.
Product codes
HRS
Device Description
The Synthes 1.5mm Mini Fragment LCP System consists of low-profile plates of various shapes as well as locking and cortex screws which are intended to treat small bones and small fragments. The plates and screws of the 1.5mm Mini Fragment LCP System are available in stainless steel and titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and small fragments
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)
Synthes Modular Mini Fragment LCP System, Synthes Stainless Steel Modular Hand System
Reference Device(s)
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Synthes. The logo consists of a stylized symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A horizontal line is present under the word "SYNTHES".
.
K09004749 1/1)
:
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| Karl J. Nittinger | ||
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6941 | ||
| APR -1 200 | ||
| Device Name: | Synthes (USA) 1.5mm Mini Fragment LCP System | |
| Classification: | Class 11, §888.3030 - Single / multiple component metallic bone | |
| fixation appliance and accessories. | ||
| Predicate Device: | Synthes Modular Mini Fragment LCP System | |
| Synthes Stainless Steel Modular Hand System | ||
| Device Description: | The Synthes 1.5mm Mini Fragment LCP System consists of low- | |
| profile plates of various shapes as well as locking and cortex screws | ||
| which are intended to treat small bones and small fragments. The | ||
| plates and screws of the 1.5mm Mini Fragment LCP System are | ||
| available in stainless steel and titanium. | ||
| Intended Use: | Synthes 1.5mm Mini Fragment LCP System is indicated for | |
| fixation of small bones and small fragments, osteotomies, | ||
| arthrodeses, replantations, and reconstructions of small bones and | ||
| small fragments, particularly in osteopenic bone. | ||
| 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 and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Mr. Karl J. Nittinger 1301 Goshen Pkwy. West Chester, PA 19380
APR - 1 2009
Re: K090047 Trade/Device Name: Synthes (USA) 1.5mm Mini Fragment LCP System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
-accessories-Regulatory Class: Class II
Product Code: HRS Dated: January 5, 2009 Received: January 7, 2009
Dear Mr. Nittinger:
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 - Mr. Karl J. Nittinger
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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Bachus
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| 2.0 | Indications for Use |
|---|---|
| 510(k) Number (if known): | K090047 (pg1/1) |
| Device Name: | Synthes (USA) 1.5mm Mini Fragment LCP System |
| Indications for Use: | Synthes 1.5mm Mini Fragment LCP System is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments, particularly in osteopenic bone. |
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Charles Beecher for
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K090047