(34 days)
Not Found
Not Found
No
The summary describes a mechanical implant system (plates and screws) for bone fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No.
The device is described as a system of metallic plates and screws intended for the fixation of fractures, malunions, non-unions, and osteotomies of the clavicle, which are structural repair functions rather than direct therapeutic actions like treating disease or restoring physiological function.
No
Explanation: The device is a surgical implant (plate and screws) used for fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "machined metallic plates and screws," which are hardware components, not software.
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. This testing is done outside of the body (in vitro).
- Device Description: The Synthes 3.5mm LCP Clavicle Plate System is described as a system of metallic plates and screws intended for the fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. This is a surgical implant used within the body to stabilize bone.
The description clearly indicates a device used for surgical intervention and internal fixation, not for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
Synthes 3.5mm LCP Clavicle Plate System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle. Synthes 3.5mm LCP Clavicle Plate System enhances fracture fixation by providing pre-contoured plates designed to fit the clavicle and design features which allow additional contouring. minimization of soft tissue irritation, and minimization of vascular trauma. The Synthes 3.5mm LCP Clavicle System includes plates with a lateral extension feature specifically designed to enhance the stability of the fixation of fractures in the distal clavicle and plates without the lateral extension feature for fixation of fractures in the clavicle shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle
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 3.5mm Dynamic Compression Locking (DCL) Plates as cleared in Synthes Small Fragment DCL System
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
§ 888.3030 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 word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized letter "R" inside of a circle. There are dashed lines above and below the word "SYNTHES".
| 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 | ||
| DEC 17 2007 | ||
| Device Name: | Synthes 3.5mm LCP Clavicle Plate System | |
| Classification: | Class II. §888.3030 - Single/multiple component metallic bone fixation appliances and accessories | |
| Predicate Device: | Synthes 3.5mm Dynamic Compression Locking (DCL) Plates as cleared in Synthes Small Fragment DCL System | |
| Device Description: | Synthes 3.5mm LCP Clavicle Plate System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the clavicle. |
Synthes 3.5mm LCP Clavicle Plate System enhances fracture fixation by providing pre-contoured plates designed to fit the clavicle and design features which allow additional contouring. minimization of soft tissue irritation, and minimization of vascular trauma. The Synthes 3.5mm LCP Clavicle System includes plates with a lateral extension feature specifically designed to enhance the stability of the fixation of fractures in the distal clavicle and plates without the lateral extension feature for fixation of fractures in the clavicle shaft. | |
| Intended Use: | Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. | |
| 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The profiles are stacked on top of each other, creating a sense of depth and representing the department's focus on people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2007 % Mr. Karl J. Nittinger Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, PA 19380 Re: K073186 Trade/Device Name: SYNTHES 3.5mm LCP Clavicle Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: Nov 12, 2007 Received: Nov 13, 2007
Dear Mr. Nittinger:
SYNTHES (USA)
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 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 N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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 stylized image inside. To the right of the word is a small, circled "R", indicating a registered trademark.
2.0
510(k) Number (if known): Device Name: Synthes 3.5mm LCP Clavicle Plate System Indications for Use: Synthes 3.5mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.
Indications for Use
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)
4
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bucher
Division of General, Restorative, and Neurological Devices
510(k) Number K073186