ISOBAR SEMI-RIGID SPINAL SYSTEM

K991326 · Scien'Tx USA, Inc. · MNI · Nov 8, 1999 · Orthopedic

Device Facts

• Record ID: K991326
• Device Name: ISOBAR SEMI-RIGID SPINAL SYSTEM
• Applicant: Scien'Tx USA, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Nov 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ISOBAR Semi-rigid Spinal System is a pedicle screw system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the ISOBAR Semi-rigid Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Story

ISOBAR Semi-rigid Spinal System is a pedicle screw fixation device for spinal stabilization. Components include pedicle screws (U-Line and Hemispherical Headed), rods, nuts, and crosslink members. System allows for single or multiple level fixation; Hemispherical Headed screws permit rod offset from screw. Used by surgeons in clinical settings to immobilize spinal segments during fusion procedures. Provides mechanical support to thoracic, lumbar, and sacral spine; implants are intended for removal following solid fusion. Benefits include stabilization of acute/chronic instabilities and deformities.

Clinical Evidence

No clinical data provided. Bench testing only: static and fatigue compression testing of U-Line Screws performed per ASTM F1717-96.

Technological Characteristics

Constructed from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. System comprises pedicle screws, rods, nuts, and crosslink members. Features U-Line screws for direct rod attachment and Hemispherical Headed screws for offset rod attachment. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including degenerative spondylolisthesis with neurological impairment, fracture, dislocation, spinal tumor, and pseudarthrosis. Also indicated for severe Grade 3 and 4 spondylolisthesis of L5-S1 using autogenous bone graft with L3-sacrum fixation.

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

• ISOBAR Spinal System (K990118)

Submission Summary (Full Text)

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## 510/k) Summary of Safety and Effectiveness

- Submitter's name: (1) Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Common or usual name:

Trade or proprietary device name:

Encore Orthopedics, Inc. 9800 Metric Blvd. Austin, TX 78758 [phone] Debbie De Los Santos November 5, 1998

ISOBAR Semi-rigid Spinal System Pedicle screw spinal system Class II

- ISOBAR Spinal System (K990118) Legally marketed predicate device: (3)
## Subject device description: (4)

Classification name:

The ISOBAR Semi-rigid System consists of pedicle screws, rods, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium allov (Ti-6Al-4V) that conforms to ASTM F136.

This system consists of pedicle screws that require rod attachment directly over the top of the screw (U-Line Screws) and a combination of screws and clamps that allow the rod to be offset from the screw (Hemispherical Headed Screws).

## (ર) Subject device intended use:

The ISOBAR Semi-rigid System is a pedicle screw system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis),

As a pedicle screw system, the ISOBAR Semi-rigid Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

## (6) Performance data:

The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the U-Line Screws was performed according to ASTM F1717-96.

#### (7) Basis for substantial equivalence:

The ISOBAR Semi-rigid Spinal System is equivalent to the ISOBAR Spinal System cleared on K990118.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol in the center. The symbol consists of three stylized, curved lines that resemble a person's profile, with the lines overlapping to create a sense of depth and movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 1999

Ms. Debbie De Los Santos Requlatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758

K991326 Re: ISOBAR Semi-Rigid Spinal System Requlatory Class: II Product Codes: MNI and MNH Dated: August 10, 1999 Received: August 11, 1999

# Dear Ms. De Los Santos:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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# Page 2 - Ms. Debbie De Los Santos

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K 9 9 1 3 ص 2 2 2

Device Name: __ ISOBAR Semi-rigid Spinal System

Indications For Use:

# ISOBAR Semi-rigid Spinal System

# Indications For Use

The ISOBAR Semi-rigid Spinal System is a pedicle screw system 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Semi-rigid Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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