BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM

K043548 · Blackstone Medical, Inc. · KWQ · Jun 14, 2005 · Orthopedic

Device Facts

• Record ID: K043548
• Device Name: BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blackstone Unity™ Anterior Lumbar Plate Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies) b) Pseudoarthrosis c) Spondylolysis d) Spondylolisthesis e) Fracture f) Neoplastic disease g) Unsuccessful previous fusion surgery h) Lordotic deformities of the spine i) Idiopathic thoracolumbar or lumbar scoliosis j) Deformity (i.e., scoliosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele k) Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity

Device Story

The Blackstone Unity™ Anterior Lumbar Plate Fixation System is a non-sterile, single-use spinal orthosis. It consists of titanium alloy plates and components used by surgeons in an operating room setting. The device provides temporary stabilization to the lumbosacral spine (L5-S1) to facilitate solid spinal fusion. It is indicated for various spinal pathologies, including degenerative disc disease, deformities, and fractures. The system is implanted anteriorly below the vascular bifurcation. It functions as a mechanical fixation device to maintain alignment and stability during the healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy components; non-sterile; single-use; anterior lumbar plate fixation system; mechanical stabilization; various sizes available.

Indications for Use

Indicated for patients requiring anterior supplemental fixation at the lumbosacral (L5-S1) level for conditions including degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fractures, neoplastic disease, failed fusion, lordotic deformities, idiopathic scoliosis, deformities with deficient posterior elements, or neuromuscular deformity.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Medtronic Sofamor Danek Pyramid™ Anterior Plate Fixation System (K013665)

Submission Summary (Full Text)

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K043548
102

JUN 1 4 2005

Premarket Notification 510(k) Blackstone Medical, Inc. Blackstone™ Unity™ Anterior Lumbar Plate Fixation System.

## 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™ Unity™ Anterior Lumbar Plate Fixation System |
| Common Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Product Code<br>& Classification: | KWQ-888.3060 - Appliance, Fixation, Spinal Intervertebral Body |
| Substantially<br>Equivalent Devices: | Medtronic Sofamor Danek<br>Pyramid™ Anterior Plate Fixation System (K013665) |

#### Device Description:

The Blackstone Unity™ Anterior Lumbar Plate Fixation System is comprised of non-sterile, single use, titanium alloy components. The system is designed for use as a supplemental fixation device for the lumbosacral level, below the bifurcation of the vascular structures. The components are offered in a variety of sizes in order to accommodate specific needs during surgery.

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#### Intended Use / Indications for Use:

The Blackstone Unity™ Anterior Lumbar Plate Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (LS-S1) level below the bifurcation of the vascular structures.

When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

- a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
- b) Pseudoarthrosis
- c) Spondylolysis
- d) Spondylolisthesis
- e) Fracture
- f) Neoplastic disease
- g) Unsuccessful previous fusion surgery
- h) Lordotic deformities of the spine
- i) Idiopathic thoracolumbar or lumbar scoliosis
- i) Deformity (i.e., scoliosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele
- k) Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity

#### Basis of Substantial Equivalence:

The Blackstone Unity™ Anterior Lumbar Plate Fixation System is substantially equivalent to the Medtronic Sofamor Danek Pyramid™ Anterior Plate Fixation System (K013665), which has been cleared by FDA for use as a fixation device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it and wings at the top. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 2005

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

Re: K043548

Trade/Device Name: UNITY Anterior Lumbar Plate System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 25, 2005 Received: May 26, 2005

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.

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### Page 2 - Mr. Dean E. Ciporkin

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri s issuated or a badevice complies with other requirements of the Act mail i Dri has made a dolor mexulations administered by other Federal agencies. You must of any reach statutes and regulations and limited to: registration and listing (21 Comply with an the Her of equinements, and manufacturing practice requirements as set OI It I art 607); idoomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction control pro risions (2001). "We'll be as described in your Section 510(k) I mis letter will anow you to begin manceing of substantial equivalence of your device to a legally prematication: The PDA maining of Eastification 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 If you desire specific acrice ior your as [phone]. Also, please note the regulation entitled, Comact the Oriece of Compuner in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or Manufacturers; internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hyat Rurder

Miriam Provost, Ph.D. Acting 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

510(k) Number (if known):

Device Name: Blackstone™ Unity™ Anterior Lumbar Plate Fixation System

#### Indications for Use:

The Blackstone Unity™ Anterior Lumbar Plate Fixation System is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral (L5-S1) level below the bifurcation of the vascular structures.

When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:

- a) Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
- b) Pseudoarthrosis
- c) Spondylolysis
- d) Spondylolisthesis
- e) Fracture
- Neoplastic disease f)
- g) Unsuccessful previous fusion surgery
- h) Lordotic deformities of the spine
- Idiopathic thoracolumbar or lumbar scoliosis i)
- Deformity (i.e., scoliosis, and/or lordosis) associated with deficient i) posterior elements such as that resulting from laminectomy, spina bifida, or mvelomenigocele
- k) Neuromuscular deformity (i.e., scoliosis, and/or kyphosis) associated with pelvic obliquity

Prescription Use × (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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510(k) Number K0933548

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