(79 days)
Not Found
NOT FOUND
No
The description focuses on the mechanical design and material of a surgical implant, with no mention of software, algorithms, or data processing related to AI/ML.
No
The device is a side plate used in hip fracture fixation (osteotomies, arthrodeses, and hip fractures), which is a surgical implant designed to provide mechanical stability rather than to treat or cure a disease or condition in a therapeutic manner.
No.
The device is described as a surgical implant for orthopedic fixation, specifically for hip fractures and related procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a "side plate" manufactured from "Ti-6A1-4V alloy," indicating it is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The DePuy ACE Trochanteric Side Plate is a surgical implant designed to be used inside the body to fix bone fractures and perform osteotomies and arthrodeses. It is a mechanical device used for structural support and fixation.
The description clearly indicates a device used in surgical procedures on the hip, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The DePuy ACE Trochanteric Side Plate is a side plate that is used in conjunction with the DePuy ACE Captured Hip Screw Assembly. The Trochanteric Side Plate is designed for use in osteomoties, arthrodeses, and hip fractures; including intertrochanteric, intracapsular, and subtrochanteric.
Product codes
87 HRS
Device Description
The DePuy ACE Trochanteric Side Plate is an optional component of the DePuy ACE Captured Hip Screw System (CHS). The new plate has a proximal extension with three holes placed in a triangular configuration. The proximal extension is designed for fixation of trochanteric fracture fragments. Hip fractures with comminution of the greater trochanter can be better controlled with use of the DePuy ACE Trochanteric Side Plate. By passing screws through the proximal flare, fixation of the greater trochanter and anti-rotation of the femoral head is controlled throughout the length of the plate. The DePuy ACE Trochanteric Side Plate is initially offered in 4, 6, and 8 hole configurations. The DePuy ACE Trochanteric Side Plate is manufactured from Ti-6A1-4V alloy.
The DePuy ACE Trochanteric Side Plate uses the same surgical technique for insertion as the DePuy ACE Captured Hip Screw Side Plate (which has been cleared to market by the FDA for hip fracture fixation since 1982). Both plates are manufactured from the same composition of Ti-6AI-4V; use the same Captured Hip Screw Assembly; are indicated for the same hip fractures; offer the same superior strength characteristics; a are a low profile design; are inherently flexible allowing for plate conformity to the femur; and offer a proximal hole for use of 6.5mm screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femur
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)
DePuy ACE Captured Hip Screw Side Plate
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
510(k) SUMMARY
APR 30 1997
| NAME OF FIRM: | DePuy ACE Medical Company |
|---|---|
| 2260 East El Segundo Blvd. | |
| El Segundo, CA 90245 |
| 510(k) CONTACT PERSON | Kathleen A. Dragovich
Regulatory Affairs Specialist
DePuy ACE Medical Company |
|------------------------------------|------------------------------------------------------------------------------------------------|
| TRADE NAME | DePuy ACE Trochanteric Side Plate |
| COMMON NAME | Bone Fixation Plate |
| CLASSIFICATION | Single/Multiple Component Metallic Bone Fixation
Appliance and Accessories, 21 CFR 888.3030 |
| DEVICE PRODUCT CODE | 87 HRS Plate, Fixation, Bone |
| SUBSTANTIALLY
EQUIVALENT DEVICE | DePuy ACE Captured Hip Screw Side Plate |
INTENDED USE:
The DePuy ACE Trochanteric Side Plate is a side plate that is used in conjunction with the DePuy ACE Captured Hip Screw Assembly. The Trochanteric Side Plate is designed for use in osteomoties, arthrodeses, and hip fractures; including intertrochanteric, intracapsular, and subtrochanteric.
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The DePuy ACE Trochanteric Side Plate is an optional component of the DePuy ACE Captured Hip Screw System (CHS). The new plate has a proximal extension with three holes placed in a triangular configuration. The proximal extension is designed for fixation of trochanteric fracture fragments. Hip fractures with comminution of the greater trochanter can be better controlled with use of the DePuy ACE Trochanteric Side Plate. By passing screws through the proximal flare, fixation of the greater trochanter and anti-rotation of the femoral head is controlled throughout the length of the plate. The DePuy ACE Trochanteric Side Plate is initially offered in 4, 6, and 8 hole configurations. The DePuy ACE Trochanteric Side Plate is manufactured from Ti-6A1-4V alloy.
The DePuy ACE Trochanteric Side Plate uses the same surgical technique for insertion as the DePuy ACE Captured Hip Screw Side Plate (which has been cleared to market by the FDA for hip fracture fixation since 1982). Both plates are manufactured from the same composition of Ti-6AI-4V; use the same Captured Hip Screw Assembly; are indicated for the same hip fractures; offer the same superior strength characteristics; a are a low profile design; are inherently flexible allowing for plate conformity to the femur; and offer a proximal hole for use of 6.5mm screw.
Based on the above information, DePuy ACE Medical Company firmly believes that the new DePuy ACE Trochanteric Side Plate is substantially equivalent to the DePuy ACE Captured Hip Screw Side Plate.