SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM

K030087 · Spinal Concepts, Inc. · NKB · Jul 17, 2003 · Orthopedic

Device Facts

• Record ID: K030087
• Device Name: SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
• Applicant: Spinal Concepts, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When intended for pedicle screw fixation, implants are 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). Levels of pedicle screw attachment for these indications range from T1 to the sacrum. When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion. As a pedicle screw system, the BacFix® Spinal Fixation System is also intended for patients having Grade 3 or Grade 4 spondylolisthesis at L5-S1, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. Levels of pedicle screw fixation for these indications range from L3 to the sacrum. When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are: Idiopathic scoliosis. Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. Spinal fractures (acute reduction or late deformity). Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Neoplastic disease. Spondylolisthesis. Spinal Stenosis. Failed previous fusion. The cable-screws, cables and spinous process grommets are indicated for: Defect of pars lateralis. Spondylolisthesis. Cables and spinous processes grommets may be used for interspinous wiring if additional stability is needed.

Device Story

BacFix® Ti Spinal Fixation System; titanium alloy (Ti-6Al-4V) spinal implants including rods, screws, cables, staples, nuts, and washers. Used by surgeons in clinical settings for spinal stabilization/immobilization. Components stabilize bone screws and distribute load over larger surface areas in anterior constructs. Non-sterile, single-use devices. Mechanical fixation provides structural support to spinal segments to facilitate fusion. Benefits include improved stability for acute/chronic spinal instabilities and deformities.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with FDA-recognized standard ASTM F1717-96 to verify that added components met design requirements and performance standards.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ASTM F136. Components include staples, nuts, washers, rods, screws, and cables. Non-sterile, single-use. Mechanical fixation system.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats degenerative disc disease, spondylolisthesis (including Grade 3/4 at L5-S1), fractures, dislocations, scoliosis, kyphosis, lordosis, spinal stenosis, tumors, and failed previous fusion. Applicable to thoracic, lumbar, and sacral spine (T1-sacrum for pedicle screws; T6-L5 for anterolateral).

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

• Spinal Concepts, Inc. BacFix® Ti Spinal Fixation System (K013887)
• Spinal Concepts, Inc. InCompass Spinal Fixation System (K021564 and K023644)
• Blackstone™ Spinal Fixation System Staple & Washer - System Addition (K022605)
• DePuy-Acromed Moss Miami (K953925)
• Synthes USS (K000450)
• Medtronic Sofamor Danek CD Horizon (K001066)
• Medtronic Sofamor Danek TSRH (K982990)

Submission Summary (Full Text)

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K030087 p ½

# JUL 17 2003

## Spinal Concepts, Inc.

# Spinal Concepts, Inc. BacFix® Ti Spinal Fixation System

### 510(k) Summary

| SUBMITTED BY | Spinal Concepts, Inc.<br>5301 Riata Park Court, Bldg. F<br>Austin, TX 78727 | | | | |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | 1649384 | | | | |
| CONTACT PERSON | <table><tr><th>Primary</th><th>Alternate</th></tr><tr><td>Lisa Peterson<br/>Regulatory Affairs Specialist<br/>Phone: [phone]<br/>Fax: [phone]</td><td>David Hooper, Ph.D.<br/>Director, Clinical and<br/>Regulatory Affairs<br/>Phone: [phone]<br/>Fax: [phone]</td></tr></table> | Primary | Alternate | Lisa Peterson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] | David Hooper, Ph.D.<br>Director, Clinical and<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Primary | Alternate | | | | |
| Lisa Peterson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] | David Hooper, Ph.D.<br>Director, Clinical and<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | | | | |
| DATE PREPARED | April 24, 2003 | | | | |
| CLASSIFICATION NAME | KWQ: Spinal Intervertebral Body Fixation Orthosis. Class II.<br>MNI: Pedicle Screw Spinal System. Class II.<br>MNH: Spondylolisthesis Spinal Fixation Device System. Class II.<br>KWP: Spinal Interlaminal Fixation Orthosis. Class II.<br>NKB: Pedicle Screw Fixation System, Degenerative Disc Disease. Class III. | | | | |
| COMMON NAME | Rod and Screw Spinal Instrumentation | | | | |
| PROPRIETARY NAME | Spinal Concepts, Inc. BacFix® Ti Spinal Fixation System | | | | |
| PREDICATE DEVICE | - Spinal Concepts, Inc. BacFix® Ti Spinal Fixation System - (K013887).<br>- Spinal Concepts, Inc. InCompass Spinal Fixation System (K021564 and K023644).<br>- Blackstone™ Spinal Fixation System Staple & Washer - System Addition (K022605).<br>- DePuy-Acromed Moss Miami (K953925)<br>- Synthes USS (K000450)<br>- Medtronic Sofamor Danek CD Horizon (K001066)<br>- Medtronic Sofamor Danek TSRH (K982990) | | | | |

### DEVICE DESCRIPTION

The purpose of this abbreviated 510(k) Notification is to add Staple, Nut and Washer components to the BacFix Spinal Fixation System and also to expand the existing indications to include anterolateral spinal fixation. The Spinal Concepts, Inc. BacFix® Ti Spinal Fixation System Staple, Nut and Washer are titanium alloy devices (Ti-6Al-4V, per ASTM F136), which are non-sterile single use components. These devices function as a means of stabilizing the bone screw and to reduce negative effects of screw to bone purchase. These components are particularly desirable in an anterior spinal construct because load can be spread over a greater surface area.

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#### INDICATIONS

When intended for pedicle screw fixation, implants are 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). Levels of pedicle screw attachment for these indications range from T1 to the sacrum.

When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

As a pedicle screw system, the BacFix® Spinal Fixation System is also intended for patients having Grade 3 or Grade 4 spondylolisthesis at L5-S1, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. Levels of pedicle screw fixation for these indications range from L3 to the sacrum.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are: Idiopathic scoliosis. Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity.

Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. Spinal fractures (acute reduction or late deformity).

Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

Neoplastic disease. Spondylolisthesis. Spinal Stenosis. Failed previous fusion.

The cable-screws, cables and spinous process grommets are indicated for: Defect of pars lateralis. Spondylolisthesis.

Cables and spinous processes grommets may be used for interspinous wiring if additional stability is needed.

#### MECHANICAL TEST DATA

Mechanical testing data was collected in accordance with FDA recognized standard ASTM F1717-96, to verify that the added components met established design requirements and performance standards.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 17 2003

Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts, Inc. 12012 Technology Blvd, Suite 100 Austin, Texas 78727

Re: K030087

Trade/Device Name: BacFix® Ti Spinal Fixation System Regulatory Number: 21 CFR 888.3070(b), 888.3050, 888.3060 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, K WQ Dated: April 24, 2003 Received: April 25, 2003

Dear Ms. Peterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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## Page 2 - Ms. Lisa Peterson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

## Spinal Concepts, Inc. BacFix® Ti Spinal Fixation System

KO300V7

Indications for Use:

When intended for pedicle screw fixation, implants are 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range from TI to the sacrum.

When intended for anterolateral screw, rod and or cable fixation of the T6-L5 spine the indications are degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

J. Mark N. Melann

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K030087

As a pedicle screw system, the BacFix® Spinal Fixation System is also intended for patients having Grade 3 or Grade 4 spondylolisthesis at L5-S1, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. Levels of pedicle screw fixation for these indications range from L3 to the sacrum.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are: Idiopathic scoliosis.

Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.

Spinal fractures (acute reduction or late deformity).

Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).

Neoplastic disease.

- Spondylolisthesis.
- Spinal Stenosis.

Failed previous fusion.

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K.a30087

The cable-screws, cables and spinous process grommets are indicated for: Defect of pars lateralis. Spondylolisthesis.

Cables and spinous processes grommets may be used for interspinous wiring if additional stability is needed.

# (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: (Optional Format 1-2-96)

for Mark N Millerson
(Division Sign Off)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number __

K030087

5301 Riata Park Court, Bldg. F Austin, Texas 78727

Spinal Concepts, Inc.

Phone: [phone] Fax: [phone]