MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM

K983258 · Spinal Concepts, Inc. · MNI · Oct 21, 1998 · Orthopedic

Device Facts

• Record ID: K983258
• Device Name: MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
• Applicant: Spinal Concepts, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinal Concepts, Inc. BacFix™ Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (T1-S1). 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 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 T1 to the sacrum. In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of solid fusion. The levels of screw fixation for these indications range from L3 to the sacrum. When intended for non-pedicle, posterior screw fixation of the noncervical spine, the indications are: 1. Idiopathic scoliosis. 2. Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spacticity. 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. 4. Spinal fractures (acute reduction or late deformity). 5. Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 6. Neoplastic disease. 7. Spondylolisthesis. 8. Spinal stenosis. 9. Failed previous fusion.

Device Story

BacFix™ Spinal Fixation System is a posterior spinal stabilization construct. Components include longitudinal spinal rods (1/4" and 3/16" diameters), spinal anchors (hooks and screws, 6.0-7.5mm diameter), and locking connectors (wedge and nut). System utilizes a three-point shear clamp mechanism; open-face wedge design allows pre-assembly outside the wound and intraoperative addition/removal of anchors. Used by surgeons in clinical settings to provide temporary stabilization of the thoracic, thoracolumbar, or lumbar spine. Output is a rigid construct that immobilizes spinal segments to facilitate fusion. Benefits include reduced surgical complexity by eliminating the need to attach nuts within the surgical opening and allowing flexible positioning of components along the rods.

Clinical Evidence

Bench testing only. Static and fatigue mechanical testing was performed and compared against published data for the Zimmer Modulock and Sofamor Danek TSRH systems. Results demonstrated the device is capable of withstanding clinical loading and maintaining mechanical integrity.

Technological Characteristics

Materials: 316L Stainless Steel and 22-13-5 Stainless Steel. Components: Longitudinal rods, hooks, screws, and transverse connectors. Mechanism: Three-point shear clamp (wedge and nut) for rod-to-anchor fixation. Sterilization: Provided sterile or non-sterile; requires user sterilization to 10^-6 sterility assurance level.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including degenerative spondylolisthesis, fractures, dislocations, scoliosis, kyphosis, spinal tumors, pseudarthrosis, degenerative disc disease, and spinal stenosis. Specific indications for severe spondylolisthesis (grades 3-4) at L3-S1 levels. Non-pedicle fixation indicated for idiopathic/neuromuscular scoliosis, deficient posterior elements, and spinal fractures.

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

• Zimmer Modulock Posterior Spinal System
• Sofamor Danek TSRH Spinal System

Submission Summary (Full Text)

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# 1983258

# OCT 21 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS BacFix™ Spinal Fixation System (K983258)

#### General Information I.

| Classification Name: | 87 Orthopedics |
|-----------------------------|---------------------------------------------------------------------------------------------------------|
| Common Name: | Appliance, Fixation, Spinal Interlaminal |
| Device Trade Name: | BacFix™ Spinal Fixation System |
| Classification Code: | This device has been placed in Class II by the<br>Orthopedics Panel. |
| Submitter's Name & Address: | Spinal Concepts, Inc.<br>8200 Cameron Road, Suite B-160<br>Austin, Texas 78754 U.S.A.<br>[phone] |

Establishment Registration No: 1649384

Contact Person: Teena M. Augostino Director, Clinical and Regulatory Affairs

Summary Preparation Date: October 15, 1998

#### II. Predicate Device

The Spinal Concepts, Inc. BacFix™ Spinal Fixation System claimed to be substantially equivalent in material, design, and function to the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System

#### III. Device Description

The BacFix™ Spinal Fixation System consists of longitudinal members (spinal rods), in a variety of diameters (1/4" and 3/16") and lengths; spinal anchor components, hooks and screws, of various sizes (6.0-7.5mm diameter screws) and types; locking connectors (wedge and nut) sized to fit the spinal rods; and a transverse connector assembly (link), also in various lengths. Hooks and screws may be placed at any position along the spinal rods and are secured with a three point shear clamp (wedge and nut). The open face of the wedge may be snapped over the spinal rod. Thus the component and wedge may be preassembled outside the wound, eliminating the need to attach the nut within the surgical opening and the need to pre-plan the position of each eyebolt on the spinal rod. Furthermore, an anchor component may be added to (or removed from) the construct at any time during the procedure.

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#### IV. Sterilization

The BacFix™ Spinal Fixation System implants and instrumentation may be provided sterile or non-sterile. 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

When intended for pedicte 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 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 T1 to the sacrum.

In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of solid fusion. The levels of 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:

- 1. Idiopathic scoliosis.
- Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spacticity. 2.
- Scoliosis with deficient posterior elements such as that resulting from laminectomy 3. or myelomeningocele.
- Spinal fractures (acute reduction or late deformity). ব ..
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- 5. Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- 6. Neoplastic disease.
- Spondylolisthesis. 7.
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တံ Spinal stenosis.
- 9. Failed previous fusion.

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#### Substantial Equivalence VI.

| 316L Stainless<br>Steel & 22-13-5<br>Stainless Steel | Rods (hard and soft - various sizes and lengths)<br>Hooks (laminar, pedicle, lumbar - right and left),<br>Rod links/wedges (various sizes and lengths)<br>Screws (angled, straight, various sizes and diameters) | Bilateral, dual spinal rods connected with transverse rod linkages.<br>Spinal rods are attached to thoracic & lumbar spine with hooks & to sacral spine with screws | 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 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 T1 to the sacrum.<br><br>In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after attainment of solid fusion. The levels of screw fixation for these indications range from L3 to the sacrum.<br><br>When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are"<br>1. Idiopathic scoliosis, 2. Neuromuscular scoliosis/ kyphoscoliosis with associated paralysis or spasticity, 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, 4. Spinal fractures (acute reduction or late deformity), 5. Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 6. Neoplastic disease, 7. Spondylolisthesis, 8. Spinal stenosis and 9. Failed previous fusion. |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 316L Stainless<br>Steel & 22-13-5<br>Stainless Steel | Rods, hooks (laminar, pedicle, lumbar), cross-links rods, screws (angled & straight) | Bilateral dual spinal rods connected with transverse rod couplers.<br>Spinal rods are attached to thoracic and lumbar spine | To provide temporary stabilization of (T1 to S1) as an adjunct to spinal bone grafting procedures. The system is also used for the correction and stabilization of scoliotic curves, for the prevention of recurrence of undesired scoliotic curves and for the stabilization of weakened trunks. When labeled for pedicle screw fixation, the implants are intended for use in grade 3 and 4 spondylolisthesis at L5-S1 |
| | | with hooks and<br>sacral spine<br>with screws. | utilizing autogenous bone graft and intended to<br>be removed after solid fusion is attained.<br>Levels of attachment for this indication range<br>from L3 to the sacrum. When labeled for non-<br>pedicle screw fixation, the system is intended<br>for hook, wire and/or sacral/iliac screw fixation<br>from the thoracic spine to the ileum/sacrum. |
| 316L Stainless<br>Steel | Rods, hooks<br>(laminar, bifid<br>pedicle and<br>lumbar), rod<br>coupler, screws<br>(angled and<br>straight) | Bilateral, dual<br>spinal rods<br>connected with<br>transverse rod<br>linkages.<br>Spinal rods are<br>attached to<br>thoracic &<br>lumbar spine<br>with hooks &<br>to sacral spine<br>with screws | To provide temporary stabilization of (T1 to<br>S1) as an adjunct to spinal bone grafting<br>procedures. The system is also used for the<br>correction and stabilization of scoliotic curves,<br>for the prevention of recurrence of undesired<br>scoliotic curves and for the stabilization of<br>weakened trunks. When labeled for pedicle<br>screw fixation, the implants are intended for<br>use in grade 3 and 4 spondylosisthesis at L5-S1,<br>utilizing autogenous bone graft and intended to<br>be removed after solid fusion is attained.<br>Levels of attachment for this indication range<br>from L3 to the sacrum. When labeled for non-<br>pedicle screw fixation, the system is intended<br>for hook, wire and/or sacral/iliac screw fixation<br>from the thoracic spine to the ileum/sacrum. |

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#### VII. Mechanical Testing

Static and fatigue testing was performed on the BacFix™ System. These data were compared with published data of various other hook, rod and serew spinal fixation systems. The results of this testing demonstrated the BacFix™ to be substantially equivalent to the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System and able to withstand clinical loading and maintain mechanical integrity.

#### VIII. Conclusion

The BacFix™ Spinal Fixation System is considered to be substantially equivalent in design, material and function to the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Ms. Teena M. Augostino Director. Regulatory and Clinical Affairs Spinal Concepts, Inc. 8200 Cameron Road, B-160 Austin, Texas 78754

Re: K983258

BacFix™ stainless steel Spinal Fixation System - expanded uses Regulatory Class: II Product Codes: MNI, KWP, and MNH Dated: September 11, 1998 Received: September 16, 1998

Dear Ms. Augostino:

We have reviewed vour 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 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). 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 (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 requirements, 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 action. In addition, FDA may publish further announcements 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 regulations.

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### Page 2 - Ms. Teena M. Augostino

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

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

Radiological Health

Enclosure

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| | INDICATION FOR USE STATEMENT |
|--|------------------------------|
|--|------------------------------|

Page I of I

510(k) Number (if known): K983258

JI ZUJ - 4 JUL

1 ねぇ 1 コメリカ - שער 1 ווכן 1 מא

Spinal Concepts, Inc. BacFix™ Spinal Fixation System Device Name:

The Spinal Concepts, Inc. BacFix™ Spinal Fixation System consists of a Indications for Use: combination of components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (T)-SI).

> 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 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 T1 to the sacrum.

In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of solid fusion. The levels of screw fixation for these indications range from L3 to the sacrum.

When intended for non-pedicle, posterior screw fixation of the noncervical spine, the indications are:

- 1. Idiopathic scoliosis.
- Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or 2. spacticity.
- 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
- 4. Spinal fractures (acute reduction or late deformity).
- 5. Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- 6. Neoplastic disease.
- 7. Spondylolisthesis.
- 8. Spinal stenosis.
- 9. Failed previous fusion.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| Prescription Use: | X<br>(Per 21 CFR 801.109) |
|-------------------|----------------------------------------------|
| | Over-The-Counter<br>(Optional Format 1-2-96) |

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K983258 |