BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE

K081849 · Blackstone Medical, Inc. · OVD · Aug 28, 2008 · Orthopedic

Device Facts

• Record ID: K081849
• Device Name: BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
• Applicant: Blackstone Medical, Inc.
• Product Code: OVD · Orthopedic
• Decision Date: Aug 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as an Intervertebral Body Fusion System: The PILLAR™ SA PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System. When used as a Partial Vertebral Body Replacement (VBR) System: The PILLAR™ SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR™ SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft. The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

Device Story

PILLAR SA PEEK Spacer System is an intervertebral body fusion and partial vertebral body replacement device. Implants are PEEK-OPTIMA LT1 (ASTM F-2026) with tantalum markers (ASTM F-560). System includes integrated anterior screw holes for titanium alloy screws and a titanium plate for screw securement. Superior/inferior surfaces feature ripple patterns for stability. Used in spinal surgery by physicians to restore biomechanical integrity, achieve decompression, and facilitate fusion. Device is implanted in the spine; provides structural support for bone graft (autograft/allograft). If fewer than four screws are used, supplemental internal fixation is required.

Clinical Evidence

No clinical data. Substantial equivalence is based on mechanical performance data and equivalence in configuration and indications for use.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 (ASTM F-2026), tantalum markers (ASTM F-560), titanium alloy screws/plate. Form factor: Intervertebral spacer with integrated screw holes and ripple-patterned surfaces. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at 1-2 contiguous lumbar levels (L2-S1) with/without Grade 1 spondylolisthesis, or for partial vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumors or fractures. Requires 6 months non-operative treatment for DDD.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350)
• Blackstone Medical, Inc. Construx Mini (K051246)
• Blackstone Medical, Inc. PILLAR Spacer System (K081177)
• Surgicraft, Ltd. STALIF TT (K041617)
• Surgicraft, Ltd. STALIF TT (K051027)
• Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109)
• Medtronic Sofamor Danek, Intrepid Spinal System (K080083)

Submission Summary (Full Text)

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## le081849

Premarket Notification Special 510(k) Blackstone Medical, Inc. PILLAR SA PEEK Spacer System System Modification

#### 510(K) SUMMARY

AUG 2 8 2008

| Sponsor: | Blackstone Medical, Inc.<br>1211 Hamburg Turnpike<br>Suite 300<br>Wayne, NJ 07470 | AUG 28 2008 |
|-----------------------|-------------------------------------------------------------------------------------------------------------|-------------|
| Registration Number: | 3004606875 | |
| Contact Person: | Whitney G. Törning, Senior Director of Regulatory Affairs &<br>Quality Assurance | |
| Telephone Number: | 973.406.2838 | |
| Fax Number: | 973.406.2938 | |
| Email: | [e-mail] | |
| Submitter: | Martin G. Sprunck<br>Regulatory Affairs Manager | |
| Manufacturer: | Blackstone Medical, Inc.<br>90 Brookdale Drive<br>Springfield, MA 01104 | |
| Registration Number: | 1225457 | |
| Trade Name: | Blackstone PILLAR™ SA PEEK Spacer System | |
| Common Names: | Intervertebral Body Fusion Device<br>Spinal Partial Vertebral Body Replacement Device | |
| Classification | Class II | |
| Device Product Codes: | MAX - Intervertebral Fusion Device with Bone Graft, Lumba<br>MQP - Spinal Vertebral Body Replacement Device | |
| Regulation Numbers: | 888.3080 - Intervertebral Body Fusion Device<br>888.3060 - Spinal Intervertebral Body Fixation Orthosis | |

#### Substantially Equivalent Devices:

- · Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350 SE 2-24-06)
- · Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05)
- · Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08)
- · Surgicraft, Ltd. STALIF TT (K041617 SE 9-8-04 and K051027 SE 6-29-05)
- · Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08)
- · Medtronic Sofamor Danek, Intrepid Spinal System (K080083 SE 4-10-08)

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2081849

Premarket Notification Special 510(k) Blackstone Medical, Inc. PILLAR SA PEEK Spacer System System Modification

#### Device Description:

The Blackstone Medical, Inc. PILLAR SA PEEK Spacer System is comprised of a variety of implants manufactured from Polyetheretherketone (PEEK-OPTIMA® LT1), as described by ASTM F-2026, with tantalum markers as described by ASTM F-560. The implants are available in multiple footprint sizes, and a variety of heights and angles of lordosis. The implants incorporate integrated anterior screw holes to allow for medial placement of titanium screws that anchor to the vertebrae, as well as a titanium plate for securing the screws once in place. The superior and inferior surfaces of the implant have a pattern of ripples that provide increased stability and help prevent movement of the device.

#### Intended Use / Indications for Use:

## When used as an Intervertebral Body Fusion System:

The PILLAR™ SA PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft.

The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System.

#### When used as a Partial Vertebral Body Replacement (VBR) System:

The PILLAR™ SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of turnors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of

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fusion for a prolonged period of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft.

The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

#### Basis of Substantial Equivalence:

Based on mechanical performance data and equivalence in configuration and indications for use, the Blackstone PILLAR SA PEEK Spacer System is substantially equivalent to the following devices, which have been cleared by FDA for the purpose of building a spinal implant construct in the non-cervical spine:

- · Blackstone Medical, Inc. Construx PL/TL Partial VBR Spacers (K060350 SE 2-24-06)
- · Blackstone Medical, Inc. Construx Mini (K051246 SE 6-14-05)
- · Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08)
- · Surgicraft, Ltd., STALIF TT (K051027 SE 6-29-05 and K041617 SE 9-8-04)
- · Surgicraft, Ltd., STALIF TT Intervertebral Body Fusion System (K073109 SE 6-4-08)
- · Medtronic Sofamor Danek, Intrepid Spinal System (K080083 SE 4-10-08)

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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 & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and clean, and it is easily recognizable.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 12 2011

Blackstone Medical, Inc. % Ms. Whitney G. Törning Senior Director of Regulatory Affairs and Quality Assurance 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470

Re: K081849

> Trade/Device Name: Blackstone PILLAR™ SA PEEK Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MQP Dated: July 30, 2008 Received: July 31, 2008

Dear Ms. Törning:

This letter corrects our substantially equivalent letter of August 28, 2008.

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 (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 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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark M. Wilkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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 PILLAR™ SA PEEK Spacer System

Indications for Use:

## When used as an Intervertebral Body Fusion System:

The PILLAR™ SA PEEK Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). The PILLAR™ SA PEEK Spacer System is intended for use with autograft.

The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PILLAR™ Spacer System.

When used as a Partial Vertebral Body Replacement (VBR) System:

The PILLAR™ SA PEEK Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ SA PEEK Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ SA PEEK Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time. The PILLAR™ SA PEEK Spacer System is intended to be used with autograft or allograft.

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# 1081849

The PILLAR™ SA PEEK Spacer System is intended for use with the four titanium alloy screws provided with the device. If the physician chooses to use fewer than four of the provided screws, then supplemental internal fixation must be used to augment stability. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

Prescription Use _ X AND/OR Over-The-Counter Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D) (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)

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Soubare buellin

Division of General, Restorative, and Neurological Devices

**510(k) Number** K081846