(202 days)
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No
The 510(k) summary describes a metallic bone fixation plate and does not mention any software, algorithms, or AI/ML capabilities.
No
The device, a bone fixation plate, is used to stabilize fractures and osteotomies, which is a supportive rather than a therapeutic function (i.e., it doesn't cure or treat the underlying condition itself, but rather holds the bones in place for healing).
No
The device is described as a metallic bone fixation plate intended for the fixation of fractures and osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a system consisting of "metallic bone fixation plates," which are hardware components.
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 provided text clearly describes the Synthes 2.4mm LCP Volar Column Distal Radius Plates as metallic bone fixation plates designed to treat fractures and osteotomies. This is a surgical implant used directly on the bone, not a device that analyzes samples outside the body.
- Intended Use: The intended use is for the fixation of fractures and osteotomies, which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the Synthes 2.4mm LCP Volar Column Distal Radius Plates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Synthes 2.4mm LCP Volar Column 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, HWC
Device Description
The Synthes 2.4mm LCP Volar Column Distal Radius Plates are part of the Synthes Locking Distal Radius System which is a system consisting of metallic bone fixation plates designed to treat fractures and osteotomies of the distal radius.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
distal radius and other small bones
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 Locking Distal Radius Plating 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.
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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).
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§ 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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Image /page/0/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. A horizontal line is present below the word, adding a sense of completion to the design.
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Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Summary Sponsor: Synthes (USA) Karl J. Nittinger - J DEC 2:3 2009 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6941 Device Name: Synthes (USA) 2.4mm LCP Volar Column Distal Radius Plates Classification: Class II, §888.3030 - Single / multiple component metallic bone fixation appliance and accessories. Predicate Device: Synthes Locking Distal Radius Plating System Device Description: The Synthes 2.4mm LCP Volar Column Distal Radius Plates are part of the Synthes Locking Distal Radius System which is a system consisting of metallic bone fixation plates designed to treat fractures and osteotomies of the distal radius. Intended Use: Synthes 2.4mm LCP Volar Column Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures of and osteotomies of the distal radius and other small bones. Information presented supports substantial equivalence. Substantial Equivalence:
KO91644
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Synthes % Mr. Karl J. Nittinger Regulatory Affairs Associate 1301 Goshen Parkway West Chester, Pennsylvania 19380
DEC 2:3 2009
Re: K091644
Trade/Device Name: Synthes 2.4mm LCP Volar Column Distal Radius Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 23, 2009 Received: October 27, 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.
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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/Resourcesfor You/Industry/default.htm.
Sincerely
Sincerely yours,
Pac. Dm. 760 Dr.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Ko91644 510(k) Number (if known): Device Name: Synthes (USA) 2.4mm LCP Volar Column Distal Radius Plates Indications for Use: Synthes 2.4mm LCP Volar Column 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 AND/OR Over-The-Counter Use (Per 21 CFR 801.109) (21 CFR 807 Subpart C) :
Carlos Concession Comers
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M.MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091641
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