UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM

K061229 · Blackstone Medical, Inc. · KWQ · Jul 24, 2006 · Orthopedic

Device Facts

• Record ID: K061229
• Device Name: UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
• Applicant: Blackstone Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Unity LX™ Anterolateral Lumbar Plate Fixation System is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine (L1-L5) above 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: Degenerative disc disease (defined as back pain of discogenic origin with 1) degenerative disc confirmed by history and radiographic studies) - 2) Pseudoarthrosis - 3) Spondylolysis - 4) Spondylolisthesis - 5) Fracture - 6) Neoplastic disease - 7) Unsuccessful previous fusion surgery - 8) Lordotic deformities of the spine - 9) Idiopathic thoracolumbar or lumbar scoliosis 10) Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or mvelomenigocele 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity

Device Story

Unity LX™ Anterolateral Lumbar Plate Fixation System; supplemental fixation device for lumbar spine (L1-L5). Components: base plate, cover plate with locking setscrew, bone screws. Used by surgeons in clinical settings to provide temporary stabilization during spinal fusion. Mechanical fixation device; no electronic or software components. Benefits patient by maintaining alignment and stability until solid fusion occurs.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

System comprises base plate, cover plate with locking setscrew, and bone screws. Mechanical fixation device; no energy source, connectivity, or software. Sterilization method not specified.

Indications for Use

Indicated for patients requiring supplemental fixation in the lumbar spine (L1-L5) for conditions including degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fractures, neoplastic disease, failed fusion, lordotic deformities, idiopathic scoliosis, deformities with deficient posterior elements (laminectomy, spina bifida, myelomeningocele), and neuromuscular deformity with pelvic obliquity.

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

• Unity™ Anterior Lumbar Plate Fixation System (K043548)
• Synthes Anterior Tension Band System (K022791)

Submission Summary (Full Text)

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# 510(k) SUMMARY

Blackstone Medical's Unity LX™ Anterolateral Lumbar Plate Fixation System

SUBMITTER: Blackstone Medical, Inc.

ADDRESS: 1211 Hamburg Turnpike Suite 300 Wayne, NJ 07470

PHONE: [phone] FAX: [phone]

CONTACT PERSON: Martin G. Sprunck Senior Regulatory Affairs Specialist

TRADE NAME: Unity LX™ Anterolateral Lumbar Plate Fixation System

COMMON NAME: Spinal Fixation System

CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060

PRODUCT CODE: KWQ - Appliance, Fixation, Spinal Intervertebral Body

Blackstone Medical, Inc. Unity™ Anterior Lumbar Plate PREDICATE DEVICES: Fixation System, (K043548 SE 6-14- 2005) Synthes Anterior Tension Band System (K022791 SE 11-13-2002)

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### Intended Use / Indications for Use

The Unity LX™ Anterolateral Lumbar Plate Fixation System is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine (L1-L5) above 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:

Degenerative disc disease (defined as back pain of discogenic origin with 1) degenerative disc confirmed by history and radiographic studies)

- 2) Pseudoarthrosis
- 3) Spondylolysis
- 4) Spondylolisthesis
- 5) Fracture
- 6) Neoplastic disease
- 7) Unsuccessful previous fusion surgery
- 8) Lordotic deformities of the spine
- 9) Idiopathic thoracolumbar or lumbar scoliosis

10) Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or mvelomenigocele

11) Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity

# Technological Characteristics

The Unity LX Anterolateral Lumbar Fixation Plate consists of:

- 1) A base plate
- 2) A cover plate with locking setscrew
- 3) Bone screws

# Performance Data

Mechanical testing of the Blackstone Medical Unity LX Anterolateral Lumbar Fixation Plate System was conducted which demonstrates that the system is substantially equivalent to predicate devices that have the same intended use, similar indications, technological characteristics and principles of operation.

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#### Substantial Equivalence

The Unity LX Anterolateral System, the Unity Anterior System and the Synthes ATB System have the same intended use and similar indications, technological characteristics and principles of operation. The only technological differences between the Unity LX Anterolateral Lumbar Fixation Plate and its predicates are minor dimensional characteristics and have been addressed with side-by-side mechanical verification testing. These differences do not present any new issues of safety or effectiveness, therefore, the Unity LX Anterolateral Lumbar Fixation Plate is substantially equivalent to its predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three human figures. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A."

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2006

Mr. Martin Sprunck Senior Regulatory Affairs Specialist Blackstone Medical, Inc. 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470

Re: K061229

> Trade/Device Name: Unity LX Anterolateral Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Codes: K WQ Dated: July 19, 2006 Received: July 20, 2006

Dear Mr. Sprunck:

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. Martin Sprunck

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. 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/industry/support/index.html.

Sincerely yours,

Barlie Brenno

Mark N. Melke 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 Statement

K061229 510(k) Number (if known):

Unity LX™ Anterolateral Lumbar Plate Fixation System Device Name:

Indications for Use:

The Unity LX™ Anterolateral Lumbar Plate Fixation System is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of 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:

- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by 1) history and radiographic studies)
- Pseudoarthrosis 2)
- 3) Spondylolysis
- Spondylolisthesis 4)
- Fracture ર)
- Neoplastic disease ()
- Unsuccessful previous fusion surgery 7)
- Lordotic deformities of the spine 8)
- Idiopathic thoracolumbar or lumbar scoliosis 9)
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that 10) resulting from laminectomy, spina bifida, or myelomenigocele
- Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity || |

Preseription Use × (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rattari Brelim

Division of Gene and Neurological Devices

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510(k) Number K001229