ULTIUM SPINAL PLATING SYSTEM

K962784 · Smith & Nephew, Inc., Orthopaedic Div. · MNH · Oct 2, 1996 · Orthopedic

Device Facts

• Record ID: K962784
• Device Name: ULTIUM SPINAL PLATING SYSTEM
• Applicant: Smith & Nephew, Inc., Orthopaedic Div.
• Product Code: MNH · Orthopedic
• Decision Date: Oct 2, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Posterior Fixation / Attachment (Pedicle fixation): The Ultium Spinal Plating System bolts when placed in the pedicles are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw system, the bolts may be used for the indications specified previously to affix the plates to vertebral levels L3 to S1 inclusive. Anterior Fixation / Attachment (anterolateral intervertebral bodies). The Ultium Spinal Plating System when attached anterolaterally to the vertebral bodies of levels T10 to S1, inclusive, is intended for the treatment of: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disk confirmed by historical and radiographic studies); pseudarthrosis, stenosis, scoliosis, spondylolisthesis; unsuccessful previous attempts at spinal fusion; or tumor resection.

Device Story

Spinal fixation system consisting of plates, washers, locking nuts, and bolts; manufactured from titanium alloy. Used by surgeons for posterior pedicle fixation (L3-S1) or anterior/anterolateral fixation (T10-S1) to stabilize the spine during fusion procedures. Provides mechanical support to vertebral segments; intended for removal after solid fusion mass development. Benefits patients by stabilizing spinal segments in cases of deformity, degeneration, or tumor resection.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM standards confirmed the system's capability to withstand in vivo loading without failure.

Technological Characteristics

Titanium alloy components; includes plates, washers, locking nuts, and bolts. Mechanical performance validated via ASTM standard test methods.

Indications for Use

Indicated for patients with severe spondylolisthesis (Grades 3-4) at L5-S1 requiring pedicle fixation with autogenous bone graft, or patients requiring anterior fixation (T10-S1) for degenerative disc disease, pseudarthrosis, stenosis, scoliosis, spondylolisthesis, failed fusion, or tumor resection.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• Simmons Plating System (Smith & Nephew Orthopaedics)
• Rogozinski Spinal Rod System (Smith & Nephew Orthopaedics)
• Steffee Plating System (VSP) (Acromed)
• DynaLok System (Danek)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness
Smith & Nephew Richards Inc.
Ultium Spinal Plating System

OCT - 2 1996

# Substantial Equivalence Information

K962784

The Ultium Spinal Plating System is similar to the following systems:

1. Simmons Plating System - Smith & Nephew Orthopaedics
2. Rogozinski Spinal Rod System - Smith & Nephew Orthopaedics
3. Steffee Plating System (VSP) - Acromed
4. DynaLok System - Danek

All of the devices listed above are similar in design to the Ultium Spinal Plating System. The safety and effectiveness of the Ultium Spinal Plating System is based on the long history of use of these devices in the market place.

# Device Description

The Ultium Spinal Plating System includes plates, washers, a locking nut, standard bolts, and offset bolts. All components are manufactured from a titanium alloy.

# Indications for Use

Posterior Fixation / Attachment (Pedicle fixation): The Ultium Spinal Plating System bolts when placed in the pedicles are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used as a pedicle screw system, the bolts may be used for the indications specified previously to affix the plates to vertebral levels L3 to S1 inclusive.

Anterior Fixation / Attachment (anterolateral intervertebral bodies). The Ultium Spinal Plating System when attached anterolaterally to the vertebral bodies of levels T10 to S1, inclusive, is intended for the treatment of: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disk confirmed by historical and radiographic studies); pseudarthrosis, stenosis, scoliosis, spondylolisthesis; unsuccessful previous attempts at spinal fusion; or tumor resection.

# Mechanical Testing

Mechanical testing was performed according to ASTM standard test methods. All of the test results indicate that the Ultium Spinal Plating System is capable of withstanding in vivo loading without failure.

JG07126B