(89 days)
Not Found
Not Found
No
The summary describes a metallic plate for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as metallic plates intended for the treatment of fractures and osteotomies, which are therapeutic interventions.
No
The device is described as a metallic plate intended for fixation of fractures and osteotomies, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a metallic plate, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures and osteotomies of bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a metallic plate intended for surgical implantation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with biological specimens in this way.
The information provided clearly describes a surgical implant used for orthopedic procedures, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
Synthes 2.4mm VA-LCP Two-Column Narrow Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Product codes
HRS, HWC
Device Description
The Synthes 2.4mm VA-LCP Two-Column Narrow Volar Distal Radius Plates are metallic plates intended for treatment of various fracture modes of the distal radius. The plates incorporate variable-angle locking hole technology and are available in versions composed of stainless steel and titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius and other small bones
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 2.4mm VA-LCP Two-Column Volar Distal Radius Plates, Synthes Variable Angle Locking Distal Radius System, Synthes Locking Distal Radius Plating System, Stryker-Leibinger Universal Distal Radius System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
3.0
1092556
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| 510(k) Summary | Page 1 of 1 | |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| Karl J. Nittinger | ||
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6941 | NOV 1 7 2005 | |
| Device Name: | Synthes (USA) 2.4mm VA-LCP Two-Column Narrow Volar Distal | |
| Radius Plates | ||
| Classification: | Class II, §888.3030 - Single / multiple component metallic bone | |
| fixation appliance and accessories. | ||
| Predicate Device: | Synthes 2.4mm VA-LCP Two-Column Volar Distal Radius Plates | |
| Synthes Variable Angle Locking Distal Radius System | ||
| Synthes Locking Distal Radius Plating System | ||
| Stryker-Leibinger Universal Distal Radius System | ||
| Device Description: | The Synthes 2.4mm VA-LCP Two-Column Narrow Volar Distal | |
| Radius Plates are metallic plates intended for treatment of various | ||
| fracture modes of the distal radius. The plates incorporate variable- | ||
| angle locking hole technology and are available in versions | ||
| composed of stainless steel and titanium. | ||
| Intended Use: | Synthes 2.4mm VA-LCP Two-Column Narrow Volar Distal Radius | |
| Plates are intended for fixation of complex intra- and extra-articular | ||
| fractures and osteotomies of the distal radius and other small bones. | ||
| Substantial Equivalence: | Information presented supports substantial equivalence. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Synthes (USA) % Mr. Karl J. Nittinger Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
NOV 17 2009
Re: K092556 Trade Name: Synthes (USA) 2.4mm VA - LCP Two-Column Narrow Volar Distal Radius Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS, HWC Dated: August 18, 2009 . Received: August 20, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Karl J. Nittinger
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jonetta J
Image /page/2/Picture/6 description: The image contains a handwritten symbol or character that appears to be a stylized letter or a combination of letters. The symbol has a loop at the top, a descending stroke that curves to the left, and a small flourish or loop on the right side of the top portion. The symbol is black against a white background, suggesting it may be part of a signature or a unique identifier.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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 design inside. The word "SYNTHES" is written in a slightly stylized font, and there is a registered trademark symbol to the right of the word. A horizontal line is present below the word.
2.0
Indications for Use
510(k) Number (if known):
Device Name:
Synthes (USA) 2.4mm VA-LCP Two-Column Narrow Volar Distal Radius Plates
92556
Indications for Use:
Synthes 2.4mm VA-LCP Two-Column Narrow Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
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)
Smetti for mxm
Division Size 260
(Division Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092556