MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM

K042514 · Blackstone Medical, Inc. · MNI · Oct 7, 2004 · Orthopedic

Device Facts

• Record ID: K042514
• Device Name: MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blackstone Modular Pedicle Screw System is intended for non-cervical use in the spine. The Blackstone Modular Pedicle Screw 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 Modular Pedicle Screw 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 neurological impairment; b) Fracture: c) Dislocation: d) Scoliosis; e) Kyphosis; f) Spinal tumor; g) Failed previous fusion (pseudarthrosis). The Blackstone Modular Pedicle Screw System, when used for anterolateral 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. The Blackstone Modular Pedicle Screw 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

Modular spinal instrumentation system; titanium alloy components; non-sterile, single-use. Surgeon attaches screws to vertebral body to build spinal implant construct; stabilizes operative site during bone graft fusion process. Used in thoracic, lumbar, and sacral spine. Provides immobilization and stabilization of spinal segments. Benefits patient by facilitating fusion in cases of instability or deformity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy components; non-sterile, single-use; modular pedicle screw design; mechanical fixation for spinal stabilization.

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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudarthrosis, spinal stenosis, and degenerative disc disease. Specific pedicle screw fixation restricted to severe L5-S1 spondylolisthesis (Grades 3-4) using autogenous bone graft, with removal after fusion.

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™ SFS 4.5mm Multi-Axial Screws (K020674)
• Blackstone™ SFS Modification to Multi-Axial Screws (K023498)
• Blackstone™ SFS 4.5mm Mono-Axial Screws (K013558)
• Blackstone™ SFS Lateral Offset (K030581)

Submission Summary (Full Text)

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Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Modular Pedicle Screw System

OCT 7 - 2004

K042514

#### 510(K) SUMMARY

| 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™ Modular Pedicle Screw System |
| Common Name: | Rod and Screw Spinal Instrumentation |
| Device Product Code<br>& Classification: | MNI - 888.3070 - Pedicle Screw Spinal System<br>KWQ - 888.3060 - Spinal Intervertebral Body Fixation Orthosis<br>MNH – 888.3070 Spondylolisthesis Spinal Fixation Device System |

#### Substantially Equivalent Devices:

Blackstone™ Spinal Fixation System (K994217) Blackstone™ SFS 4.5mm Multi-Axial Screws (K020674) Blackstone™ SFS Modification to Multi-Axial Screws (K023498) Blackstone™ SFS 4.5mm Mono-Axial Screws (K013558) Blackstone™ SFS Lateral Offset (K030581)

#### Device Description:

The Blackstone™ Modular Pedicie Screw System is comprised of non-sterile, single use, titanium alloy components. The Blackstone Modular Pedicle Screws, smgm attaches to the vertebral body by means of screws to the non-cervical spine and a Jown a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space.

#### Intended Use / Indications for Use:

The Blackstone Modular Pedicle Screw System is intended for non-cervical use in the spine.

The Blackstone Modular Pedicle Screw 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.

Page 1 of 2

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2

The Blackstone Modular Pedicle Screw 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 in thilities or deformities of the thoracic, lumbar and sacral spinc:

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

The Blackstone Modular Pedicle Screw System, when used for anterolateral 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: t)
- g) Trauma (i.e., fracture or dislocation);
- h) Failed previous fusion.

The Blackstone Modular Pedicle Screw 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:
- Trauma (i.e., fracture or dislocation); g)
- Failed previous fusion. h)

## BASIS OF SUBSTANTIAL EQUIVALENCE:

By its very nature, the Blackstone™ Modular Pedicle Screw System is substantially equivalent to the Blackstone™ Spinal Fixation System (K994217), which has been cleared by FDA for use in spinal fusion surgery.

Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2004

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

Re: K042514

Trade/Device Name: Blackstone™ Modular Pedicle Screw System Regulation Number: 21 CFR 888.3060, 21 CFR 888.3070 Regulation Name: Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: MNH, KWQ, MNI Dated: September 12, 2004 Received: September 16, 2004

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 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.

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Page 2 – Mr. Dean E. Ciporkin

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 yours,

Mark N Melker

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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# Indications for Use

Ko42514 510(k) Number (if known):

Device Name: Blackstone™ Modular Pedicle Screw System

### Indications for Use:

The Blackstone Modular Pedicle Screw System is intended for non-cervical use in the spine.

The Blackstone Modular Pedicle Screw 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 facing actored bone gran only,
below): and
- d) Who are having the device removed after the development of a solid fusion mass.

The Blackstone Modular Pedicle Screw 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 spondylolistinesis with objective evidence of neurologic impairment;
- b) Fracture:
- c) Dislocation:
- d) Scollosis:
- e) Kyphosis:
- Spinal tumor; t)
- g) Failed previous fusion (pseudarthrosis).

The Blackstone Modular Pedicle Screw 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 pack pain of discogeni origin with degenerative disc confirmed by history and radiographia
- b) Spinal stenosis:
- c) Spondylolisthesis;
- d) Spinal deformities (i.e., scoliosis, kyphosis, lordosis) ivision of General, Restorative,
- e) Pseudoarthrosis;
- f) Tumor:
- g) Trauma (i.e., fracture or dislocation).
- h) Failed previous fusion.

Neurological Devices

**510(k) Number** K042574

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The Blackstone Modular Pedicle Screw 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

ﻢ

Murk N. Millerson

Division of General, Restorative, and Neurological Devices

**510(k) Number** K042514