(87 days)
Not Found
Not Found
No
The summary describes a bone plating system and explicitly states that the technological characteristics are similar to predicate devices, with no mention of AI/ML, image processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is described as a "Plating System" intended for the "treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia," which indicates a therapeutic purpose.
No
The intended use describes the DePuy Proximal Tibia Plating System as a device for treatment of fractures and other conditions of the proximal tibia, indicating it is a therapeutic device rather than a diagnostic one.
No
The device description and intended use clearly indicate a physical plating system for bone fixation, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The DePuy Proximal Tibia Plating System is a surgical implant (plates and screws) used to fix fractures and other bone issues in the proximal tibia. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes the treatment of bone conditions and fractures, which is a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, the DePuy Proximal Tibia Plating System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Proximal Tibia Plating System is intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.
Product codes
HRS, HWC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia
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)
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
K090877 (pg. 1 of 1)
Section 5 — 510(k) Summary
| Submitted by: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581
Phone: (305) 269-6386
Fax: (305) 269-6441 | JUN 26 2009 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs | |
| Date Prepared: | March 30, 2009 | |
| Proprietary Name: | Proximal Tibia Plating System | |
| Common Name: | Plate, Fixation, Bone | |
| Classification
Name: | Single/multiple component metallic bone fixation appliances
and accessories (21 CFR § 888.3030) | |
| Predicate Devices: | The DePuy Proximal Tibia Plating System is substantially
equivalent to currently marketed devices. | |
| Intended Use: | The DePuy Proximal Tibia Plating System is intended for
treatment of nonunions, osteotomies, malunions, osteopenic
bone and fractures of the proximal tibia, including simple,
comminuted, lateral wedge, depression, medial wedge,
bicondylar combination of lateral wedge and depression,
periprosthetic and fractures with associated shaft fractures. | |
| Technological
Characteristics: | The technological characteristics of the DePuy Proximal Tibia
Plating System are similar to the predicate devices including
design and material. | |
| Summary of
Substantial
Equivalence: | The DePuy Proximal Tibia Plating System is substantially
equivalent to currently marketed devices as demonstrated with
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 logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
JUN 26 2009
9200 Corporate Boulevard
Food and Drug Administration
Public Health Service
Rockville MD 20850
DePuy Orthopaedics. Inc. % Ms. Suzana Otaño Project Manager 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K090877
Trade/Device Name: Proximal Tibia Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS, HWC Dated: March 30, 2009 Received: March 31, 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. .
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 (OS) 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. 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" (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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buellm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 4 - Indications for Use Statement
510(k) Number:
Device Name:
Proximal Tibia Plating System
Indications For Use:
The DePuy Proximal Tibia Plating System is intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.
X 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)
(Division Sign-Off)
Division of Surgical, Orthopedia and Restorative Devices
510(k) Number K090872
Page 1 of 1
Proximal Tibia Plating System Traditional 510(k) DePuy Orthopaedics, Inc.
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