ANTERIOR DYNAMIZED SYSTEM

K953978 · Acromed Corp. · KWQ · Feb 19, 1997 · Orthopedic

Device Facts

• Record ID: K953978
• Device Name: ANTERIOR DYNAMIZED SYSTEM
• Applicant: Acromed Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anterior Dynamized system is intended for use in anterior decompression instrumentation and fusion for kyphotic deformities, post traumatic kyphotic deformities, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.

Device Story

Anterior spinal fixation system; construct includes titanium alloy dynamized closed screws, anterior rods, closed transverse fixator connectors, and closed blockers. System allows continual compression of bone graft while preventing hyperextension. Cephalad screws allow longitudinal rod movement; caudal screws use set screws for fixation. Used by surgeons in anterior spinal procedures; provides structural stability during fusion. Benefits patient by maintaining alignment and facilitating bone healing in degenerative or traumatic spinal conditions.

Clinical Evidence

Bench testing only. Static compression bending and torsion testing performed to characterize stiffness, strength, and maximum applied moment. Dynamic bending compression testing performed to characterize fatigue life.

Technological Characteristics

Materials: Implant-grade titanium alloy. Components: Dynamized closed screws, anterior rods (1/4 inch OD), closed transverse fixator connectors with V-Groove Hollow-Ground (VHG) design, and closed blockers. Mechanical fixation via set screws and hex nuts. Non-active, mechanical implant system.

Indications for Use

Indicated for patients requiring anterior decompression and fusion for kyphotic deformities, post-traumatic kyphotic deformities, degenerative disc disease, burst fractures, tumors, or failed prior spinal surgery. Treatment levels T10-L3.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Dwyer Spinal Instrumentation
• Kaneda Anterior System
• ISOLA Anterior System

Submission Summary (Full Text)

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# K953978
## ALC Dynamized Fixation System
510(k) Summary

**COMPANY:** AcroMed Corporation
3303 Carnegie Avenue
Cleveland, Ohio 44115
FEB 19 1997

**TRADE NAME:** ALC Dynamized Fixation System

**CLASSIFICATION:** Spinal intervertebral body fixation orthosis. Class II

**DESCRIPTION:**

The Anterior Dynamized system is a construct consisting of implant grade titanium alloy dynamized closed screws, closed transverse fixator connector, anterior rods and a closed blocker. The Anterior Dynamized construct allows continual compression of the bone graft while avoiding hyperextension type forces on the construct. The components of the Anterior Dynamized system have been designed with anatomic limitations in mind.

### Dynamized Closed Screws:

The dynamized closed screw is manufactured from a single rod of implant grade titanium alloy material into two distinct sections; the cancellous thread and rod interface. Multiple lengths are available to allow for surgeon latitude. The closed screw allows superior to inferior or inferior to superior placement of a rod. Closed screws used in the caudal portion of the construct contain a set screw which is designed to affix the rod into the opening of the closed screw. Closed screws used in the cephalad portion of the construct do not use a set screw to allow for longitudinal movement of the construct along the rods. The set screw is precision machined from the same implant grade titanium alloy material. The dynamized closed screw is placed into the vertebral body of the spine. Four dynamized closed screws are used per construct.

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Closed Transverse Fixator Connector:

The closed transverse fixator connector is composed of two closed transverse connectors and a transverse fixator plate. The closed transverse connectors are designed with the patented V-Groove Hollow-Ground (VHG) design to allow proper seating of the titanium rod. A transverse fixator plate is used to span the gap between the connectors. The fixator plates are machined with two elongated slots which facilitate horizontal positioning of the plate. The transverse plates are available in two sizes, small and large. The rod is secured to the connector and transverse plate with a set screw and hex nut. Two closed transverse fixator connectors are used per construct.

Closed Blocker:

The closed blocker is of the same design as a closed transverse connector. Using a set screw, the closed blocker is attached to the anterior rod above the dynamized closed screw. The closed blocker is designed to stop hyperextension type forces on the construct. One closed blocker is required per construct.

Anterior Rod:

The titanium alloy rod is offered in 1/4 inch outer diameter and two lengths are available for that diameter; 18.0mm and 24.0mm. Two rods are required in the construct and are cut to the appropriate length during the procedure.

PERFORMANCE DATA:

Non-Clinical:

Static compression bending and torsion were performed on the Anterior Dynamized bi-level construct to characterize the properties of stiffness, strength, and maximum applied moment (torque). Dynamic bending compression testing was also performed to characterize fatigue life.

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# INDICATIONS:

The Anterior Dynamized system is intended for use in anterior decompression instrumentation and fusion for kyphotic deformities, post traumatic kyphotic deformities, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), burst fractures, tumors and previous failed surgery of the spine. The intended levels for treatment range from T10 to L3.

# SUBSTANTIAL EQUIVALENCY:

Dwyer Spinal Instrumentation
Kaneda Anterior System
ISOLA Anterior System