(84 days)
HRS
Not Found
No
The description focuses on the mechanical properties and design of a metal plate for bone fixation, with no mention of software, algorithms, or AI/ML terms.
No
The device is a metal plate intended for internal fixation of fractures and osteotomies, which is a structural support rather than a therapeutic treatment in itself (e.g., delivering medication, energy, or actively modifying a biological process to cure or alleviate a disease).
No
Explanation: The device is described as a metal plate intended for fixation of fractures and osteotomies, which is a therapeutic rather than diagnostic function. It does not mention any role in diagnosing conditions or analyzing medical data.
No
The device description clearly states it is a "machined metal plate" and is manufactured in "titanium or stainless steel," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states this device is a "machined metal plate" 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 to stabilize bones.
- Intended Use: The intended use is for surgical fixation of bone fractures, not for testing biological samples.
This device is a surgical implant/orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The Synthes 2.4 mm VA-LCP Two-Column 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 (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Synthes 2.4 mm Variable Angle LCP (VA-LCP) Two-Column Volar Distal Radius Plate is a machined metal plate that is designed for fixation of various fracture modes of the distal portion of the radius. The 2.4 mm VA-LCP Two-Column Volar Distal Radius plate allows fragment-specific fracture fixation by providing the flexibility to lock screws in the head or shaft of the plate in trajectories that can diverge from the central axis of the plate hole. Synthes' variable angle locking technology enhances plate-screw construct stability. The plates are manufactured in either titanium or stainless steel.
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): 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 LCP Volar Distal Radius Plates
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.
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| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6940 | ||
| Contact: | Sheri L. Musgnung | |
| Synthes (USA) | ||
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-6940 | ||
| FAX (484) 356-9682 | MAR 6 2009 | |
| Device Name: | Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plate | |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone | |
| fixation appliances and accessories | ||
| Predicate Device: | Synthes LCP Volar Distal Radius Plates | |
| Device Description: | The Synthes 2.4 mm Variable Angle LCP (VA-LCP) Two-Column | |
| Volar Distal Radius Plate is a machined metal plate that is designed | ||
| for fixation of various fracture modes of the distal portion of the | ||
| radius. The 2.4 mm VA-LCP Two-Column Volar Distal Radius | ||
| plate allows fragment-specific fracture fixation by providing the | ||
| flexibility to lock screws in the head or shaft of the plate in | ||
| trajectories that can diverge from the central axis of the plate hole. | ||
| Synthes' variable angle locking technology enhances plate-screw | ||
| construct stability. The plates are manufactured in either titanium | ||
| or stainless steel. | ||
| Intended Use: | The Synthes 2.4 mm VA-LCP Two-Column 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. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) % Ms. Sheri L. Musgnung Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380
6 2009 MAR
Re: K083694
Trade/Device Name: Synthes 2.4mm VA-LCP Two-Column Volar Distal Radius Plates Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliance and accessories
Regulatory Class: II Product Code: HRS Dated: December 11, 2008 Received: December 12, 2008
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 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 Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting 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. Melker
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. To the left of the word is a circular logo with a stylized image inside. A horizontal line is present below the word and logo.
2.0
Indications for Use
510(k) Number (if known):
Device Name:
_Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates
Indications for Use:
The Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extraarticular 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)
Mark A. Milken
(Division Sign-Off) (Division Sign-Un)
Division of General, Restorative,
Division of General, Devices Division of General Devices
510(k) Number
0000004