BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS

K013885 · Blackstone Medical, Inc. · MNI · Feb 1, 2002 · Orthopedic

Device Facts

• Record ID: K013885
• Device Name: BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
• Applicant: Blackstone Medical, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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; and g) Failed previous fusion (pseudarthrosis). The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications: a) Degenerative disc disease (as 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) Pseudarthrosis; f) Tumor; g) Trauma (i.e., fracture or dislocation); h) Previous failed fusion. The Blackstone Spinal Fixation System, when used for posterior non-pedicle fixation, is intended for the following indications: a) Degenerative disc disease (as 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) Pseudarthrosis; f) Tumor; g) Trauma (i.e., fracture or dislocation); h) Previous failed fusion.

Device Story

Blackstone Spinal Fixation System Posterior Hooks are titanium alloy components; adjunct to existing spinal fixation system (screws/rods). Used by surgeons in clinical settings to build spinal implant constructs for immobilization/stabilization during fusion procedures. Components are non-sterile, single-use; fully interchangeable with previously cleared Blackstone system components. Provides mechanical support to spinal segments; aids in fusion development; intended for removal after solid fusion mass formation.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to predicate device.

Technological Characteristics

Titanium alloy; non-sterile, single-use components; posterior hook form factor; mechanical fixation; manual surgical instrumentation.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine instabilities/deformities including degenerative spondylolisthesis, fractures, dislocations, scoliosis, kyphosis, spinal tumors, pseudarthrosis, spinal stenosis, and degenerative disc disease. Specific 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

• Danek CD Horizon Spinal System (K981676)

Submission Summary (Full Text)

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P'i3 K01385

FEB 01 2002

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Name of Firm: | Blackstone Medical, Inc.<br>90 Brookdale Drive<br>Springfield, MA 01104 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Alan Lombardo<br>Director of Engineering |
| Trade Name: | Blackstone™ Spinal Fixation System<br>Posterior Hooks (System Addition) |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code<br>& Classification: | MNH 888.3070 - Spondylolisthesis Spinal<br>Fixation Device System<br>KWQ 888.3060 - Spinal Intervertebral Body Fixation<br>Orthosis<br>MNI 888.3070 - Pedicle Screw Spinal System<br>KWP - 888.3050 - Spinal Interlaminal Fixation Orthosis |
| Substantially<br>Equivalent Devices: | Danek CD Horizon Spinal System (K981676) |

### Device Description:

The Blackstone™ Spinal Fixation System Posterior Hooks are a titanium alloy; multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct.

The Blackstone™ Spinal Fixation System consists of an assortment of screws and rods, which have received 510k clearance (K994217 & 003735) (K013558 pending). The Posterior Hooks are new implant offerings, which are an adjunct and are fully interchangeable with the Spinal Fixation System (K994217 & 003735) (K013558 pending).

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4/3 C013885

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

#### Intended Use / Indications for Use:

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;
- 0) 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; and
- g) Failed previous fusion (pseudarthrosis).

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

- a) Degenerative disc disease (as 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) Pseudarthrosis;
- f) Tumor;
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.

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3/3 K013RRS

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

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

a) Degenerative disc disease (as 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) Pseudarthrosis;
- f) Tumor;
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The Blackstone™ Spinal Fixation System Posterior Hooks by their very nature are substantially equivalent to the Danek CD Horizon Spinal System (K981676), which has been cleared by FDA for certain anterior and pedicle fixation use indications.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is written in all capital letters and is arranged in a circular fashion to follow the shape of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Mr. Alan Lombardo Director Engineering Blackstone Medical, Inc. 90 Brookdale Drive Springfield, Massachusetts 01104

K013885 Re:

> Blackstone™ Spinal Fixation System Posterior Hooks Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3070, 21 CFR 888.3050 Regulatory Class: Class II Product Code: MNI, KWQ, MNH, KWP Dated: November 21, 2001 Received: November 23, 2001

Dear Mr. Lombardo:

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 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 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 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 - Mr. Alan Lombardo

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 nredicate 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, (Jease 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark M Milliken

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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Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

p.i/2

510(k) Number:

K013885

Device Name: Blackstone™ Spinal Fixation System

Mark M. Milken

Division of General, Restorative and Neurological Devices

#### Indications for Use:

KO13885 510(k) Number

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; and ি

- g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle fixation, is intended for the following indications:

- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis;
- c) Spondylolisthesis;

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# 10013888

14:

Premarket Notification Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Posterior Hooks (System Addition) Confidential

- d) Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- e) Pseudarthrosis;
- Tumor; f)
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.

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

a) Degenerative disc disease (as 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) Pseudarthrosis;
- f) Tumor;
- g) Trauma (i.e., fracture or dislocation);
- h) Previous failed fusion.

Concurrence of CDRH, Office of device Evaluation

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR801.109

b. Mark N. Mullen

ivision of Gener | Restorative and Neurological J. Ices

510(k) Number K013883