(60 days)
No
The device description focuses solely on mechanical components for fracture fixation and makes no mention of AI or ML.
No
The device is a hip screw system used for rigid internal fixation of proximal femur fractures, which is a structural support device rather than one that treats or prevents disease.
No
The Vigor Compression Hip Screw is described as a means of rigid internal fixation for fractures of the proximal femur, meaning it is used for treatment (fixing) rather than for diagnosing any condition.
No
The device description explicitly details physical implants (Bone Screws, Compression Screws, Lag Screws, Side Plates) and instrumentation, indicating it is a hardware-based medical device.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Vigor Compression Hip Screw is a physical implant designed for rigid internal fixation of bone fractures. It is surgically implanted into the body.
- Intended Use: The intended use clearly states it's for "rigid internal fixation of stable and unstable fractures of the proximal femur." This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
Therefore, based on the provided information, the Vigor Compression Hip Screw is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vigor Compression Hip Screw is indicated as a means of rigid internal fixation of stable and unstable fractures of the proximal femur in which a stable medial buttress can be reconstructed and is intended for the management of intertrochanteric, subtrochanteric and basilar neck fractures and selected trochanteric non-unions.
Product codes
87JDO
Device Description
The Vigor Compression Hip Screw System is intended as a means of rigid internal fixation for fractures of the proximal femur. The Vigor System implants consist of Bone Screws; Compression Screws, Lag Screws and Side Plates, and are offered in a wide, incremental range of sizes to ensure optimum selection for a proper fixation. The Vigor full-length threaded Bone Screws and Compression Bone Screws are available in a range of sizes from 22.0 mm to 60.0 mm in length. Vigor Lag Screws and Super Lag Screws feature a flattened, square base that engages the inner surface of the implant barrel for increased rotational stability. These Lag Screws are available in a range of sizes from 50.0 mm to 150.0 mm in length, in 5.0 mm increments. And, finally, a trio of low-profile Side Plates are included in the system. Vigor offers the standard 4-hole, 5-hole and 6hole plates, each available in a 135°, 140° or 145° configuration.
The Vigor System instrumentation set consists of the standard instrumentation required for each indicated procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal 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)
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
SEP - 6 1996
962644
SUMMARY OF SAFETY AND EFFECTIVENESS VIGOR COMPRESSION HIP SCREW SYSTEM
I. General Information
| Classification Name: | Device, Fixation, Proximal Femoral Implant |
|---|---|
| Common Name: | Compression Hip Screw |
| Device Trade Name: | Vigor Compression Hip Screw System |
| Classification Code: | 87JDO |
| Submitter's Name & Address: | Deutschland Surgical Incorporated |
| 1222 Commerce Street, Suite #415 | |
| Dallas, Texas 75202-4306 | |
| Establishment Registration No: | 1646853 |
| Contact Person: | Thomas Wolter |
Summary Preparation Date: July 5, 1996
II. Predicate Device
The Vigor Compression Hip Screw is claimed to be substantially equivalent in material, design, and function to the Synthes Dynamic Hip Screw cleared by FDA under 510(k) K791619 on August 28, 1979.
III. Device Description
The Vigor Compression Hip Screw System is intended as a means of rigid internal fixation for fractures of the proximal femur. The Vigor System implants consist of Bone Screws; Compression Screws, Lag Screws and Side Plates, and are offered in a wide, incremental range of sizes to ensure optimum selection for a proper fixation. The Vigor full-length threaded Bone Screws and Compression Bone Screws are available in a range of sizes from 22.0 mm to 60.0 mm in length. Vigor Lag Screws and Super Lag Screws feature a flattened, square base that engages the inner surface of the implant barrel for increased rotational stability. These Lag Screws are available in a range of sizes from 50.0 mm to 150.0 mm in length, in 5.0 mm increments. And, finally, a trio of low-profile Side Plates are included in the system. Vigor offers the standard 4-hole, 5-hole and 6hole plates, each available in a 135°, 140° or 145° configuration.
The Vigor System instrumentation set consists of the standard instrumentation required for each indicated procedure.
Premarket Notification: Vigor Compression Hip Screw
1
IV. Sterilization
Vigor Implants and Instrumentation are provided non-sterile. Implants are for single use only. Both implants and instruments must be sterilized prior to use in accordance with the recommended sterilization parameters described in the package insert in order to achieve a sterility assurance level of 10-6.
V. Indications for Use
The Vigor Compression Hip Screw is indicated as a means of rigid internal fixation of stable and unstable fractures of the proximal femur in which a stable medial buttress can be reconstructed and is intended for the management of intertrochanteric, subtrochanteric and basilar neck fractures and selected trochanteric non-unions.
VII. Substantial Equivalence
The Vigor Compression Hip Screw System is considered to be substantially equivalent to the Synthes Dynamic Hip Screw[K791619] distributed by Synthes (U.S.A.) at 1690 Russell Road, Paoli, PA 19301.
| Feature | Vigor Compression Hip Screw | Synthes Dynamic Hip Screw |
|---|---|---|
| Material | 316L Stainless Steel | 316L Stainless Steel |
| Design | Bone, Compression and Lag Screws, | |
| low-profile, angled side plates and | ||
| associated instrumentation. | Bone, Compression and Lag Screws, | |
| low-profile, angled side plates and | ||
| associated instrumentation | ||
| Function | Rigid internal fixation to fractures of | |
| the proximal femur. | Rigid internal fixation to fractures of | |
| the proximal femur. |
VIII. Conclusion
The Vigor Compression Hip Screw System is considered to be substantially equivalent in design, material and function to the Synthes Dynamic Hip Screw and is believed to perform as well as the Synthes System.
Premarket Notification: Vigor Compression Hip Screw