BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR

K030862 · Blackstone Medical, Inc. · MNI · Apr 17, 2003 · Orthopedic

Device Facts

• Record ID: K030862
• Device Name: BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
• Applicant: Blackstone Medical, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Apr 17, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients: a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; b) Who are receiving fusion using autogenous bone graft only; c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) Who are having the device removed after the development of a solid fusion mass. The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: a) Degenerative spondylolisthesis with objective evidence of neurologic impairment; b) Fracture; c) Dislocation; d) Scoliosis; e) Kyphosis; f) Spinal tumor; g) Failed previous fusion (pseudarthrosis). The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis); e) Pseudoarthrosis; f) Tumor; g) Trauma (i.e., fracture or dislocation); h) Failed previous fusion. The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications: a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e., scoliosis, kyphosis and/or lordosis); e) Pseudoarthrosis; f) Tumor; g) Trauma (i.e., fracture or dislocation); h) Failed previous fusion.

Device Story

Titanium alloy (6AL-4V ELI) spinal fixation system; includes screws, hooks, rods, and rigid cross connectors. Used by surgeons in non-cervical spinal procedures to build implant constructs for immobilization and stabilization. Attached to vertebral bodies via screws. Provides structural support to facilitate fusion in patients with spinal deformities or instabilities. System is non-sterile and single-use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Titanium alloy (6AL-4V ELI, ASTM F136). Components: Screws, hooks, rods, and rigid cross connectors. Application: Non-cervical spinal fixation. Sterilization: Non-sterile, single-use.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion in the thoracic, lumbar, and sacral spine. Conditions include degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, spinal stenosis, and degenerative disc disease. Pedicle screw use restricted to severe L5-S1 spondylolisthesis (Grades 3-4) with autogenous bone graft.

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

• Blackstone™ Spinal Fixation System (K994217)
• Blackstone™ Spinal Fixation System Second Generation Cross Connector (K003735)

Reference Devices

• K013558
• K013885
• K020674
• K023498
• K003537

Submission Summary (Full Text)

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K030862 Page 1/3

Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Rigid Cross Connector (System Modification) Confidential

APR 1 7 2003

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Name of Firm: | Blackstone Medical, Inc.<br>90 Brookdale Drive<br>Springfield, MA 01104 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Dean E. Ciporkin<br>Director, Regulatory Affairs and Quality Assurance |
| Trade Name: | Blackstone™ Spinal Fixation System<br>Rigid Cross Connector |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code<br>& Classification: | MNH – 888.3070 – Spondylolisthesis Spinal Fixation<br>Device System<br>KWQ - 888.3060 - Spinal Intervertebral Body Fixation<br>Orthosis<br>MNI - 888.3070 - Pedicle Screw Spinal System |
| Substantially<br>Equivalent Device: | Blackstone™ Spinal Fixation System (K994217)<br>Blackstone™ Spinal Fixation System Second Generation Cross<br>Connector (K003735) |

#### Device Description:

The Blackstone Spinal Fixation System is a titanium alloy (6AL-4V ELI, per ASTM F136) device comprised of a variety of non-sterile, single use components. The Blackstone Spinal Fixation System Rigid Cross Connector is a modification to the Spinal Fixation System, which allows a surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.

The Blackstone Spinal Fixation System consists of an assortment of screws, hooks, rods, and cross connectors that have received 510(k) clearance (K994217, K013558, K013885, K020674, K023498, K003537).

{1}------------------------------------------------

Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Rigid Cross Connector (System Modification) Confidential

#### Intended Use / Indications for Use:

The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (1.3 and below): and
- d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

- a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation;
- d) Scoliosis;
- e) Kyphosis;
- f) Spinal tumor;
- g) Previous failed fusion (pseudarthrosis).

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) Spinal stenosis;
- c) Spondylolisthesis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) Pseudoarthrosis;
- () Tumor:
- g) Trauma (i.e., fracture or dislocation).
- h) Previous failed fusion.

The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

- a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis:
- c) Spondylolisthesis:
- d) Spinal deformities (i.e., scoliosis, kyphosis and/or lordosis);
- e) Pseudoarthrosis;
- Tumor; f)
- g) Trauma (i.e., fracture or dislocation);
- Previous failed fusion. h)

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# K030862 Page3/3

Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Rigid Cross Connector (System Modification) Confidential

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone Rigid Cross Connector, by its very nature, is substantially equivalent to the Blackstone Spinal Fixation System (K994217, K003735), which has been cleared by the FDA for certain anterior and pedicle fixation indications.

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Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three overlapping human profiles facing to the right, with a wavy line below them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 7 2003

Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104

Re: K030862

Trade Name: Blackstone™ Spinal Fixation System - Rigid Cross Connector Regulation Number: 21 CFR 888.3070, 888.3060, 888.3050 Regulation Name: Pedicle screw spinal system, Spinal intervertebral body fixation orthosis. Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWQ, KWP Dated: March 14, 2003 Received: March 18, 2003

Dear Mr. Ciporkin:

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 - Mr. Dean E. Ciporkin

forth in the quality systems (OS) 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

sincerely, yours,

Mark N Milless

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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## KU3U6bd PAGE 112

Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Rigid Cross Connector (System Modification) Confidential

510(k) Number: K030862

## Device Name: Blackstone™ Spinal Fixation System

#### Indications for Use:

The Blackstone Spinal Fixation System is intended for non-cervical use in the spine.

The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:

- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

- a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation:
- d) Scoliosis;
- e) Kyphosis;
- Spinal tumor; f)
- g) Failed previous fusion (pseudarthrosis).

Mark N. Milken

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

510(k) Number -

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## KO30862 PAGE 2/2

Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Rigid Cross Connector (System Modification) Confidential

The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) Spinal stenosis:
- c) Spondylolisthesis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) Pseudoarthrosis;
- f) Tumor;
- g) Trauma (i.e., fracture or dislocation).
- h) Failed previous fusion.

The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:

- a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
Concurrence of CDRH, Office of Device Evaluation

- b) Spinal stenosis;
- c) Spondylolisthesis;
- d) Spinal deformities (i.e., scoliosis, kyphosis and/or lordosis);
- e) Pseudoarthrosis;
- f) Tumor;
- g) Trauma (i.e., fracture or dislocation);
- h) Failed previous fusion.

| | (Division Sign-Off) |
|---------------|-----------------------------------------------------------|
| | Division of General, Restorative and Neurological Devices |
| 510(k) Number | K 030862 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|