VIGOR COMPRESSION HIP SCREW SYSTEM

K962644 · Deutschland Surgical, Inc. · JDO · Sep 6, 1996 · Orthopedic

Device Facts

• Record ID: K962644
• Device Name: VIGOR COMPRESSION HIP SCREW SYSTEM
• Applicant: Deutschland Surgical, Inc.
• Product Code: JDO · Orthopedic
• Decision Date: Sep 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System provides rigid internal fixation for proximal femur fractures. Components include bone screws, compression screws, lag screws, and side plates. Lag screws feature flattened square base for rotational stability. Implants available in various lengths and plate configurations. Used by surgeons in clinical settings to stabilize fractures, facilitating bone healing. Instrumentation set included for surgical procedure. Implants are single-use.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: 316L Stainless Steel. Components: Bone screws (22-60mm), lag screws (50-150mm), and side plates (4, 5, 6-hole; 135°, 140°, 145° angles). Non-sterile; requires user sterilization to 10^-6 SAL.

Indications for Use

Indicated for patients with stable or unstable proximal femur fractures, including intertrochanteric, subtrochanteric, basilar neck fractures, and selected trochanteric non-unions, where a stable medial buttress can be reconstructed.

Regulatory Classification

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.

Predicate Devices

• Synthes Dynamic Hip Screw (K791619)

Submission Summary (Full Text)

{0}

SEP - 6 1996
K962644

# 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 6-hole 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
Deutschland Surgical Incorporated:
Submitted: July 5, 1996
Page 83

{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
Deutschland Surgical Incorporated:
Submitted: July 5, 1996