(53 days)
Synthes Volar LCP Distal Radius Plates, Stryker Leibinger's Volar Plates
Not Found
No
The description focuses on mechanical components (plates and screws) for fracture fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a system of plates and screws used for fixation of fractures and osteotomies of bones, which is a therapeutic intervention.
No
The device is described as a fixation system (plates and screws) for fractures and osteotomies, which is a therapeutic rather than a diagnostic function.
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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Synthes VA-LCP Distal Radius System consists of "machined metallic plates and screws" intended for "fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones." This is a surgical implant used within the body to stabilize bones.
- Intended Use: The intended use is for fixing fractures and osteotomies, which is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Product codes
HRS
Device Description
Synthes VA-LCP Distal Radius System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal portion of the radius. Synthes VA-LCP Distal Radius System enhances fragment-specific fracture fixation by providing the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole.
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 Volar LCP Distal Radius Plates, Stryker Leibinger's Volar Plates
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
K071184 (pg 1/1)
JUN 2 2 2007
Page _________________________________________________________________________________________________________________________________________________________________________
| 510(k) Summary | Page 1 of 1 |
|---|---|
| Sponsor: | Synthes (USA) |
| Sheri L. Musgnung | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6940 | |
| Device Name: | Synthes Variable Angle- Locking Compression Plate (VA-LCP) Distal Radius System |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone fixation appliances and accessories |
| Predicate Device: | Synthes Volar LCP Distal Radius Plates |
| Stryker Leibinger's Volar Plates | |
| Device Description: | Synthes VA-LCP Distal Radius System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal portion of the |
radius.
Synthes VA-LCP Distal Radius System enhances fragment-specific fracture fixation by providing the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole.
Intended Use:
3.0
Synthes VA-LCP Distal Radius System is 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
Image /page/1/Picture/13 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wings, representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2007
Synthes (USA) % Ms. Sheri L. Musgnung Sr. Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K071184
Trade/Device Name: Synthes Variable Angle – Locking Compression Plate (VA – LCP) Distal Radius 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: April 27, 2007 Received: April 30, 2007
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
2
Page 2 - Ms. Sheri L Musgnung
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.
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) 276-0120. 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 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 Buem
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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| 2.0 | Indications for Use | (pg 1/1) | |
|---|---|---|---|
| 510(k) Number (if known): | K071184 | ||
| Device Name: | Synthes Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System | ||
| Indications for Use: | Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. | ||
| 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)
Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number_ 10 2-1184
(00004
.