BLACKSTONE PILLAR XL PEEK SPACERS

K082235 · Blackstone Medical, Inc. · MAX · Sep 4, 2008 · Orthopedic

Device Facts

• Record ID: K082235
• Device Name: BLACKSTONE PILLAR XL PEEK SPACERS
• Applicant: Blackstone Medical, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Sep 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

When used as an intervertebral body fusion device, the PILLAR™ 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™ Spacer System is intended for use with autograft and supplemental internal fixation. 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. The PILLAR™ PL spacer is used singly or in pairs, and is implanted using a posterior approach. The PILLAR™ TL spacer is used singly or in pairs, and is implanted using a transforaminal approach. The PILLAR™ AL spacer is used singly, and is implanted using an anterior approach. The PILLAR™ XL spacer is used singly, and is implanted using a lateral approach. When used as a Partial Vertebral Body Replacement (VBR) System, the PILLAR™ 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™ Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The PILLAR™ 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 Partial VBR device is intended to be used with autograft or allograft. The PILLAR™ Spacer System is intended for use with internal fixation. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS).

Device Story

PILLAR XL PEEK Spacer is an intervertebral body fusion and partial vertebral body replacement device; manufactured from PEEK-OPTIMA I.T. with Tantalum markers; available in various footprints, heights, and profiles (parallel/lordotic). Device implanted by surgeons via lateral approach (XL variant) to restore spinal curvature and biomechanical integrity; requires supplemental internal fixation (e.g., Blackstone SFS) and bone graft (autograft/allograft). Rippled surface pattern enhances stability and prevents migration. Used in clinical settings for spinal stabilization in DDD, tumor resection, or fracture treatment.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: PEEK-OPTIMA I.T. (ASTM F-2026) and Tantalum markers (ASTM F-560). Design: Parallel and lordotic profiles with rippled surface texture. Non-sterile. Standalone use prohibited; requires supplemental internal fixation.

Indications for Use

Indicated for skeletally mature patients with lumbar DDD (L2-S1) at 1-2 levels, including those with Grade 1 spondylolisthesis or prior non-fusion surgery, following 6 months of failed non-operative treatment. Also indicated for thoracolumbar (T1-L5) partial vertebral body replacement for tumors or fractures to restore height and achieve decompression.

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. PILLAR Spacer System (K081177)
• NuVasive CoRoent System (K071795)

Submission Summary (Full Text)

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K082235

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

# 510(K) SUMMARY

| Name of Firm: | Blackstone Medical, Inc.<br>1211 Hamburg Turnpike<br>Wayne, NJ 07470 | SEP - 4 2008 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------|--------------|
| Registration Number: | 3004606875 | |
| 510(k) Contact: | Whitney Törning, Senior Director of Regulatory Affairs and<br>Quality Assurance | |
| Telephone Number: | 973.406.2838 | |
| Fax Number: | 973.406.2938 | |
| Email: | [e-mail] | |
| Submitter: | Martin G. Sprunck<br>Regulatory Affairs Manager | |
| Common Names: | Intervertebral Body Fusion Device<br>Spinal Partial Vertebral Body Replacement Device | |
| Trade Name: | PILLAR XL PEEK Spacer | |
| System Name: | PILLAR Spacer System | |
| Classification: | Class II | |
| Product Codes: | MAX - Intervertebral Fusion Device with Bone Graft, Lumbar<br>MQP -- Spinal Vertebral Body Replacement Device | |
| Regulatory<br>Classification(s): | 888.3080 - Intervertebral Body Fusion Device<br>888.3060 - Spinal Intervertebral Body Fixation Orthosis | |
| Review Panel: | Orthopedic Device Panel | |
| 510(k) Date: | August 6, 2008 | |

## Substantially Equivalent Devices:

- · Blackstone Medical, Inc. PILLAR Spacer System (K081177 SE 7-23-08)
- · NuVasive CoRoent System (K071795 SE 12-4-07)

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Image /page/1/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence reads 'K082235'. The characters are written in a simple, slightly irregular style, typical of handwriting.

### Device Description:

The PILLAR™ XL PEEK Spacers consist of a variety of implants manufactured from PEEK-OPTIMA® I.T (Polyetheretherketone), as described by ASTM F-2026, with Tantalum markers as described by ASTM F-560. The implants are available in a variety of footprint sizes. Additionally, they are offered in parallel and lordotic profiles in order to restore the natural curvature of the spine. The implants are available in various heights, in one millimeter increments. The superior and inferior surfaces of the implant have a pattern of ripples to provide increased stability and help prevent anterior/posterior movement of the device.

The PILLAR XL PEEK Spacers are intended for intervertebral body fusion or partial vertebral body replacement to aid in the surgical correction and stabilization of the spine,

The PILLAR XL PEEK Spacer components are not intended to be used as stand-alone devices. The PILLAR XI. PEEK Spacers must be used with supplemental internal fixation and are provided non-sterile.

#### Intended Use / Indications for Use:

- When used as an intervertebral body fusion device, the PILLAR™ 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 nonfusion surgery at the involved level(s).
The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation. 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 PILLARTM Spacer System.

The PILLAR™ PL spacer is used singly or in pairs, and is implanted using a posterior approach.

The PILLARTM TL spacer is used singly or in pairs, and is implanted using a transforaminal approach.

The PILLARIM AL spacer is used singly, and is implanted using an anterior approach.

The PILLAR™ XL spacer is used singly, and is implanted using a lateral approach.

When used as a Partial Vertebral Body Replacement (VBR) System, the PILLARTM Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.c., 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

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tissues, and to restore the height of a collapsed vertebral body. The PILLAR™ Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ 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 Partial VBR device is intended to be used with autograft or allograft.

The PILLAR™ Spacer System is intended for use with internal fixation. 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 evaluations, and equivalence in configuration, indications for use, and fundamental scientific technology, the Blackstone PILLAR XL PEEK Spacers are 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. PILLAR Spacer System (K080628 SE 7-23-08)
- · NuVasive CoRoent System (K071795 SE 12-4-07)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Blackstone Medical, Inc. % Ms. Whitney G. Torning 1211 Hamburg Turnpike, Suite 300 Wayne, New Jersey 07470

SEP - 4 2008

Re: K082235

> Trade/Device Name: PILLAR™ XL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervetebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, MQP Dated: August 06, 2008 Received: August 07, 2008

Dear Ms. Torning:

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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Dr w 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, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, noan 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, TDA consisted 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 100-1050.

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Page 2 - Ms. Whitney G. Torning

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 I legal] marketed predicate device results in a classification for your device and thus, perrects 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlet Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millican

Mark N. Melkerson 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

| 510(k) Number (if known): | K082235 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: PILLAR™ XL PEEK Spacers

Indications for Use:

When used as an intervertebral body fusion device, the PILLAR™ 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 spondylolisthess at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

The PILLAR™ Spacer System is intended for use with autograft and supplemental internal fixation. 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.

The PILLARIM PL spacer is used singly or in pairs, and is implanted using a posterior approach. The PILLAR™ TL spacer is used singly or in pairs, and is implanted using a transforampal approach. The PILLARTM AL spacer is used singly, and is implanted using an anterior approach. The PILLAR™ XL spacer is used singly, and is implanted using a lateral approach.

When used as a Partial Vertebral Body Replacement (VBR) System, the PILLAR™ Spacer System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tamas top actience antenor of the spinal cord and neural lissues, and to restore the height of a collapsed vertebral body. The PILLAR™ Spacer System is also indicated for treating fractures of the thoracic and lumbar spine.

The PILLAR™ 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 Partial VBR device is intended be used with autograft or allograft.

The PILLAR™ Spacer System is intended for use with internal fixation. As an example, the supplemental internal fixation system that may be used is the Blackstone Medical, Inc. Spinal Fixation System (SFS),

Prescription Use X (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)

Barbara Bruckner

Page 1 of 1

**(Division Sign-Off)**
Division of General, Restorative,
and Neurological Devices

510(k) Number K082235