CRYSTAL

K073351 · Spinal Elements, Inc. · ODP · Jan 24, 2008 · Orthopedic

Device Facts

• Record ID: K073351
• Device Name: CRYSTAL
• Applicant: Spinal Elements, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Jan 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft. When used as an intervertebral body fusion device, the Crystal device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

Device Story

Crystal is a box-shaped intervertebral body fusion/vertebral body replacement device; features surface teeth for fixation; manufactured from titanium alloy (Ti-6Al-4V) or PEEK. Used in thoracic/thoracolumbar spine (T1-L5) for tumor/trauma or cervical spine (C3-C7) for degenerative disc disease. Implanted via open, anterior approach; requires supplemental spinal fixation systems (e.g., pedicle screws, rods, plates). Interior spacer packed with autograft or allograft to facilitate fusion. Device provides structural support to replace collapsed/damaged vertebrae or maintain disc space height; aids in spinal stabilization and fusion; benefits patients by restoring spinal integrity and alleviating pain associated with disc degeneration or vertebral instability.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Box-shaped geometry with surface teeth; materials: titanium alloy (Ti-6Al-4V) or PEEK. Mechanical device; no energy source or software components.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement (T1-L5) due to tumor or trauma, or cervical spinal fusion (C3-C7) for degenerative disc disease. Contraindications include patients not skeletally mature or those without confirmed discogenic origin back pain.

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.

Submission Summary (Full Text)

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JAN 2 4 2008

Page lot 2

#### 510(k) Summary Crystal® K073351 510(k) Number

| Manufacturer Identification | |
|-----------------------------|--------------------------------------------------|
| Submitted by: | Spinal Elements, Inc. |
| | 2744 Loker Ave. W., Suite 100 |
| | Carlsbad, CA 92010 |
| | 760-607-0121 |
| Contact Information: | Kerri DiMartino |
| | Regulatory Affairs Specialist |
| | Spinal Elements, Inc. |
| | 2744 Loker Ave. W., Suite 100 |
| | Carlsbad, CA 92010 |
| | 760-607-1816 |
| | [e-mail] |
| Date Prepared: | November 28, 2007 |
| Device Indentification | |
| Proprietary Name: | Crystal® |
| Common Name: | Intervertebral Body Fusion Device |
| | |
| Device Classification: | 21 CFR 888.3080 (orthosis, spinal intervertebral |
| | fusion) |

### Device Description

Spinal Elements' Crystal device is a generally box-shaped devices with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device may be made from titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK).

#### Intended Use of the Device

When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft

When used as an intervertebral body fusion device, the Crystal device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with

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Spinal Elements, Inc. Premarket Notification - Crystal®

K073351

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degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

## Substantial Equivalence

Crystal was shown to be substantially equivalent through comparison to predicate intervertebral body fusion devices.

### Performance Data

Mechanical testing indicates that the Crystal device is capable of performing in accordance with its intended use.

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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 consists of a stylized eagle with three tails, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2008

Spinal Elements, Incorporated c/o Ms. Kerri DiMartino Regulatory Affairs Specialist 2744 Loker Avenue West, Suite 100 Carlsbad, CA 92010

Re: K073351

> Trade/Device Name: Crystal Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 28, 2007 Received: November 29, 2007

Dear Ms. DiMartino:

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 - Ms. Kerri DiMartino

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 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 Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 M. Mckesson

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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K073351
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# Indications for Use

K073351 510(k) Number (if known):

Crystal® Device Name:

#### Indications for Use:

When used as a vertebral body replacement, the Crystal device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

When used as an intervertebral body fusion device, the Crystal device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

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)

Mark A. Milliman

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Division of General, Restorative, corological Devices

510(k) Number K07339