(71 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used for internal fixation of bones, which is a supportive rather than a therapeutic function.
No
Explanation: The device is described as titanium plates and screws for internal fixation of small bones, indicating it is an orthopedic implant for treatment rather than diagnosis.
No
The device description clearly states it is a series of titanium plates and screws, 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states the device is a system of titanium plates and screws intended for internal fixation of small bones, specifically the distal radius. This is a surgical implant used to stabilize bone fractures.
- Lack of IVD Characteristics: The description does not mention any interaction with bodily specimens, analysis of biological markers, or diagnostic purposes.
Therefore, based on the provided information, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The system is intended for use in internal fixation of small bones-primarily the distal radius in the forearm.
Product codes
87HRS
Device Description
The R. R. P. S. Radius Reconstruction Plating System is a series of titanium plates and screws with plates of T configurations and varying lengths. These plates are attached to bone using 2.7 mm diameter titanium bone. All screws are fully threaded and self-tapping with cross-slotted heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones-primarily the distal radius in the forearm
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Alta® Modular Trauma Small Bone Plating System, Synthes® Small Fragment and Mini Set
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
19616
JUN 2 8 1996
Device: R. R. P. S. Radius Reconstruction Plating System
510(k) SUMMARY
| Proprietary Name: | R. R. P. S. Radius Reconstruction Plating System |
|---|---|
| Common Name: | Small Bone Plating System |
| Classification Name and Reference: | Single/Multiple Component Metallic Bone Fixation |
| Appliances and Accessories 888.3030 | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87HRS |
| For information contact: | Frank Maas |
| Manager, Regulatory Affairs | |
| Howmedica Inc. | |
| 359 Veterans Boulevard | |
| Rutherford, NJ 07070 | |
| Telephone: | (201)-507-7875 |
| Fax: | (201)-507-6870 |
The R. R. P. S. Radius Reconstruction Plating System is a series of titanium plates and screws with plates of T configurations and varying lengths. The system is intended for use in internal fixation of small bones-primarily the distal radius in the forearm. These plates are attached to bone using 2.7 mm diameter titanium bone. All screws are fully threaded and self-tapping with cross-slotted heads.
The substantial equivalence of these devices is based on equivalence in intended use, design, materials and operating principles to several legally marketed devices including the Alta® Modular Trauma Small Bone Plating System (Howmedica Inc.) and the Synthes® Small Fragment and Mini Set (Synthes USA).