(26 days)
No
The summary describes a mechanical plating system for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a plating system intended for fixation of fractures and fusions, serving as an implant to stabilize bone, rather than directly treating a disease or condition.
No
The device description indicates it is a surgical implant designed for fixation of fractures and other bone conditions, rather than for diagnosing medical conditions.
No
The device description clearly describes physical plates and screws used for bone fixation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures, fusions, osteotomies and non-unions" of various bones. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system of plates and screws used for bone fixation. This aligns with a surgical implant, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to physically stabilize bone.
N/A
Intended Use / Indications for Use
The Anatomic Locked Plating System 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, HWC, HTN
Device Description
The Anatomic Locked Plating System Long Plate Line Extension offers various longer length anatomically contoured plates for use with nonlocking, locking and variable angle screws. With conventional non-locking 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.
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
Load and bend testing demonstrated that the Long Plate Line Extension performed equivalently to the predicate devices, successfully meeting the pre-determined 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
K101421 (1/2)
510(k) Summary JUN 1 6 2010 Submitted by: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581 Phone: (305) 269-6386 Fax: (305) 269-6441 Contact Person: Suzana Otaño, Project Manager, Regulatory Affairs Date Prepared: May 19, 2010 General The name of the device is: Provisions Proprietary Name Common or Usual Name Anatomic Locked Plating System Plate, Fixation, Bone Long Plate Line Extension Name of The device is substantially equivalent to the currently marketed DePuy Anatomic Locked Plating System Long Plate Line Extension System. Predicate Devices K082300 and DePuy's Small Fragment Locking Plating System K072083. Classification Class II, 21 CFR 888.3030 Performance Performance standards have not been established by the FDA under Standards section 514 of the Food, Drug and Cosmetic Act for these devices. Device The Anatomic Locked Plating System Long Plate Line Extension offers Description various longer length anatomically contoured plates for use with nonlocking, locking and variable angle screws. With conventional non-locking 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. Indications for The Anatomic Locked Plating System Long Plate Line Extension is Use 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. Technological The technological characteristics of the Anatomic Locked Plating System Characteristics Long Plate Line Extension are similar to the predicate devices in both design and material. The systems are manufactured from titanium allov. Dimensional characteristics are similar among the systems including thickness, width and length.
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Summary of Substantial Equivalence The Anatomic Locked Plating System Long Plate Line Extension is substantially equivalent to the predicate devices as confirmed through bench testing. Load and bend testing demonstrated that the Long Plate Line Extension performed equivalently to the predicate devices, successfully meeting the pre-determined acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 6 2010
DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Regulatory Affairs Project Manager 700 Orthopaedic Drive Warsaw, Indiana 16581
Re: K101421
Trade/Device Name: DePuy Anatomic Locked Plating System Long Plate Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC, HTN Dated: May 19, 2010 Received: May 20, 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 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
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Page 2 - Ms. Suzana Otaño
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.
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 vou
Barbara Kuchno
Mark N. Melk 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:
K101421
DePuy Anatomic Locked Plating System Long Device Name: Plate Line Extension
Indications For Use:
The DePuy Anatomic Locked Plating System 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.
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)
Omitu der mxm
(P/L) Si to
(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101421
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DePuy Anatomic Locked Plating System Long Plate Line Extension Special 510(k)