(88 days)
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Not Found
No
The summary describes a mechanical plating system for bone fixation and makes no mention of AI or ML technology, image processing, or data-driven performance metrics.
Yes
The device is described as "intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones," which directly addresses and treats medical conditions.
No
Explanation: The device is described as a "Plating System" intended for "stabilization and fixation of fractures, revision procedures, fusions, reconstructions... and non-unions." This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description and intended use clearly describe a "Plating System" for fracture and fusion, which are physical implants and associated surgical tools, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones". This describes a surgical implant used directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The description of this device does not involve any such testing.
- Anatomical Site: The anatomical sites listed are parts of the skeletal system where the implant is surgically placed.
Therefore, the DePuy Fracture and Fusion Plating System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Fracture and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
Product codes
HRS, HWC
Device Description
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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
hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis
Indicated Patient Age Range
adult and pediatric patients (adolescents [> 12 - 21 years of age])
Intended User / Care Setting
Prescription Use (Per 21 CFR 801 Subpart D)
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
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
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
K093474 #1/1.
SECTION 5-510(K) SUMMARY
FEB - 2 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
November 4, 2009 Date Prepared:
DePuv Fracture and Fusion Plating System Proprietary Name:
Common Name: Plate, Fixation, Bone
Classification Single/multiple component metallic bone fixation appliances Name: and accessories (21 CFR § 888.3030)
The DePuy Fracture and Fusion Plating System is substantially Predicate Devices: equivalent to currently marketed devices.
Intended Use:
The DePuy Fracture and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and nonunions of the bones of the hand, foot, wrist, ankle, finger, toe. humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [> 12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
- The technological characteristics of the DePuv Fracture and Technological Characteristics: Fusion Plating System are similar to the predicate devices including design and material.
Summarv of The DePuv Fracture and Fusion Plating System is substantially Substantial equivalent to currently marketed devices as demonstrated with Equivalence: pre-clinical data. No new issues of safety or efficacy have been raised.
1
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 depiction of an eagle or bird-like figure with outstretched wings. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581
FEB - 2 2010
Re: K093474
Trade/Device Name: DePuy Fracture and Fusion Plating System Regulation Number: 21 CFR 888.3030 ·
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II
Product Code: HRS, HWC Dated: November 4, 2009 Received: November 6, 2009
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. 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.
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 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 - Ms. Suzana Otaño
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" (21 CFR 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/ReportalProblem/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/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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SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number: K093474
DePuy Fracture and Fusion Device Name: Plating System
Indications For Use:
The DePuy Fracture and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
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)
Oputa for mxn
(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093474
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Fracture and Fusion Plating System Traditional 510(k) DePuy Orthopaedics, Inc.
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