(27 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant and its performance testing, with no mention of AI or ML technology.
Yes
The device is intended for the fixation of fractures, fusions, osteotomies, and nonunions, which are medical treatments.
No
The device is an orthopedic implant system designed for fracture fixation and does not perform any diagnostic functions.
No
The device description clearly indicates it is a system of physical plates and screws used for bone fixation, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a surgical implant (a plate and screws) used for the fixation of fractures and other bone issues. It is used directly on the patient's body during surgery, not for testing samples outside the body.
The description clearly indicates its purpose is mechanical support and stabilization of bones, which is a therapeutic function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Anatomic Locked Plating System Extra Long Plate Line Extension is intended for fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.
Product codes
HRS
Device Description
The Anatomic Locked Plating System Extra Long Plate Line Extension Device Description offers various longer length anatomically contoured plates for use with non-locking, locking and variable angle screws. With conventional nonlocking plating, compression of the plate to the bone is a necessary mode of action. However, with locking plating technology, the plate does not need to contact bone or load against the periosteum for construct strength. The locking plate/screw construct provides stability even in osteopenic bone where screw purchase can be more difficult. These posterior lateral plates will be available in 210mm and 250mm lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula
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
The Anatomic Locked Plating System Extra Long Plate Line Extension is substantially equivalent to the predicate devices as confirmed through bench testing. Load and bend testing, as well as validation in cadaveric models, demonstrated that the Extra Long Plate Line Extension performed equivalently to the predicate devices, successfully meeting the predetermined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
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
K103408
pg 1/2
DEC 1 6 2010
510(k) Summary
DePuy Orthopaedics, Inc. Submitted by: 700 Orthopaedic Drive Warsaw, IN 46581 Phone: (305) 269-6386 Fax: (305) 269-6441 Contact Person: Suzana Otaño, Project Manager, Regulatory Affairs Date Prepared: November 17, 2010 General The name of the device is: Provisions Proprietary Name Common or Usual Name Anatomic Locked Plating System Plate, Fixation, Bone Extra Long Plate Line Extension The device is substantially equivalent to the currently marketed DePuy Name of Predicate Anatomic Locked Plating System Extra Long Plate Line Extension System. K082300 and DePuy's Large Fragment Locking Plating System Devices K072423. Class II, 21 CFR 888.3030 Classification Performance Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act for these devices. Standards The Anatomic Locked Plating System Extra Long Plate Line Extension Device Description offers various longer length anatomically contoured plates for use with non-locking, locking and variable angle screws. With conventional nonlocking plating, compression of the plate to the bone is a necessary mode of action. However, with locking plating technology, the plate does not need to contact bone or load against the periosteum for construct strength. The locking plate/screw construct provides stability even in osteopenic bone where screw purchase can be more difficult. These posterior lateral plates will be available in 210mm and 250mm lengths. The Anatomic Locked Plating System Extra Long Plate Line Extension is Indications for intended for fixation of fractures, fusions, osteotomies and non-unions of Use the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.
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K103408
Pg2/2
Technological Characteristics
The technological characteristics of the Anatomic Locked Plating System Extra Long Plate Line Extension are similar to the predicate devices in both design and material. The systems are manufactured from titanium alloy. Dimensional characteristics are similar among the systems including thickness, width and length.
Summary of Substantial Equivalence
The Anatomic Locked Plating System Extra Long Plate Line Extension is substantially equivalent to the predicate devices as confirmed through bench testing. Load and bend testing, as well as validation in cadaveric models, demonstrated that the Extra Long Plate Line Extension performed equivalently to the predicate devices, successfully meeting the predetermined acceptance criteria.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
DePuy Orthopaedics, Inc % Ms. Susan Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581
DEC 16 2019
Re: K103408
Trade/Device Name: DePuy Anatomic Locked Plating System Extra Long Plate Line Extension Regulation Number: 21 CFP. 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 17, 2010 Received: November 19, 2010
Dear Ms. Otaño:
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 noi 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Ms. Susan Otaño
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 liusting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of modical device-related adverse events) (21 CFR 803); 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 100-0-1050,
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/ucm1118001.html 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" (21CF) Plat 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 tolloffer no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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510(k) Number:
K103408
DEC 1 6 2010
DePuy Anatomic Locked Plating System Extra Device Name: Long Plate Line Extension
Indications For Use:
The DePuy Anatomic Locked Plating System Extra Long Plate Line Extension is intended for fixation of fractures, fusions, osteotomies and nonunions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone.
Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ar M. Melkorm
(Division $)gn-Off)
Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K103408