CONSTRUX MINI PEEK TI SPACER SYSTEM

K121649 · Orthofix · ODP · Nov 29, 2012 · Orthopedic

Device Facts

• Record ID: K121649
• Device Name: CONSTRUX MINI PEEK TI SPACER SYSTEM
• Applicant: Orthofix
• Product Code: ODP · Orthopedic
• Decision Date: Nov 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System). Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Device Story

Intervertebral body fusion device; PEEK core with integrated porous titanium alloy (Ti-6Al-4V) end plates; hollow cage design. Implanted via anterior approach in cervical spine; stabilizes adjacent vertebrae; maintains disc height; prevents vertebral collapse. Not for stand-alone use; requires supplemental fixation (e.g., anterior cervical plate) and autograft. Used by surgeons in clinical settings. Benefits include facilitation of spinal fusion in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077-11 (static/dynamic torsion, axial compression, compression shear) and ASTM F2267-04 (subsidence). Results demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Hollow cage intervertebral spacer; PEEK core with porous Ti-6Al-4V end plates. Parallel and lordotic profiles. Mechanical testing per ASTM F2077-11 and ASTM F2267-04. Provided sterile.

Indications for Use

Indicated for spinal fusion at one level in the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease (DDD) defined as discogenic neck pain confirmed by history and radiography. Requires at least 6 weeks of prior non-operative treatment. Must be used with autograft and supplemental fixation.

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

• CONSTRUX Mini PEEK Spacer System (K101812)
• Titan Spine Endoskeleton TC (K100889)

Submission Summary (Full Text)

{0}------------------------------------------------

### 510(k) SUMMARY

# NOV 2-9 2012

## CONSTRUX Mini® PEEK Ti Spacer System

| Submitter Information | |
|-----------------------------------------------------|---------------------------------------------------------------|
| Name: | Orthofix Inc. |
| Address: | 3451 Plano Parkway |
| | Lewisville, TX 75056 |
| Telephone Number: | 214.937.2000 |
| Fax Number: | 214-937-3322 |
| Email: | [e-mail] |
| Registration Number: | 3008524126 |
| Contact Person: | Natalia Volosen |
| | Senior Regulatory Affairs Specialist |
| Date Prepared: | November 28, 2012 |
| Name of Device<br>Trade Name / Proprietary<br>Name: | CONSTRUX Mini® PEEK Ti Spacer System |
| Common Name: | Intervertebral body fusion device |
| Product Code: | ODP - cervical intervertebral fusion device with bone graft |
| Regulatory Classification: | Class II - 21CFR 888.3080 - Intervertebral body fusion device |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K101812 - CONSTRUX Mini PEEK Spacer System,<br>SE 9-27-10 |
| | K100889 - Titan Spine Endoskeleton TC, SE 7-29-10 |
| Reason for 510(k) Submission: | New product offering |

#### Device Description

The CONSTRUX Mini PEEK Ti Spacer System is comprised of a variety of implants that has a PEEK core with integrated porous Titanium end plates. The CONSTRUX Mini PEEK Ti spacer is implanted in the cervical intervertebral disc space and is intended to facilitate vertebral fusion by stabilizing adjacent vertebrae, maintaining disc height, and preventing the collapsing of one vertebrate onto another.

{1}------------------------------------------------

The CONSTRUX Mini PEEK Ti Spacer System is not intended to be used as a stand-alone device. The CONSTRUX Mini PEEK Ti Spacer System must be used with supplemental fixation. The CONSTRUX Mini PEEK Ti implants are provided sterile.

#### Intended Use / Indications for Use

The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

| Summary of the Technological Characteristics of the Device Compared to the Selected |
|-------------------------------------------------------------------------------------|
| Predicate Devices |

| Characteristic | Subject Device | Predicates | |
|--------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Device Name | CONSTRUX Mini<br>PEEK Ti Spacer<br>System | CONSTRUX Mini PEEK<br>Spacer System<br>(K101812) | Titan Spine<br>Endoskeleton TC<br>(K100889) |
| Method of Fixation | IBD spacer used with<br>autograft and<br>supplemental fixation | IBD spacer used with<br>autograft and<br>supplemental fixation | IBD spacer used with<br>autograft and<br>supplemental fixation |
| Implantation | Anterior approach | Anterior approach | Anterior approach |
| Design | Hollow cage | Hollow cage | Hollow cage |
| Profile | Parallel and lordotic | Parallel and lordotic | Parallel and lordotic |
| Material | Polyetheretherketone<br>and Titanium alloy (Ti-<br>6Al-4V) | Polyetheretherketone)<br>and commercially pure<br>Titanium | Titanium alloy<br>(Ti-6Al-4V) |

#### PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

| Characteristic | Standard / Test/ FDA Guidance |
|-------------------------------------------|-------------------------------|
| Static and Dynamic Torsion Test | ASTM F2077-11 |
| Static and Dynamic Axial Compression Test | ASTM F2077-11 |
| Static and Dynamic Compression Shear Test | ASTM F2077-11 |
| Subsidence Test | ASTM F2267-04 |

#### Performance Data Summary

Mechanical testing for the CONSTRUX Mini PEEK Ti Spacer System was conducted in accordance to ASTM F2077-11 standard for Test Method for Intervertebral Body Fusion Devices and in accordance to ASTM F2267-04 standard for Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device. Test results demonstrated that the new, proposed device is substantially equivalent to predicate device that have the same intended use, similar indications, technological characteristics and principles of operation.

{2}------------------------------------------------

K121649 Page 3 of 3

#### Basis of Substantial Equivalence

The new CONSTRUX Mini PEEK Ti Spacer System is substantially equivalent in design, configuration, function, indications for use and materials to the CONSTRUX Mini PEEK Spacer System and Titan Spine Endoskeleton TC device.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: November 29, 2012

Orthofix Incorporated % Ms. Natalia Volosen Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K121649

Trade/Device Name: CONSTRUX Mini PEEK Ti Spacer System Regulation Number: 21 CFR 888.3080 Regulatory Class: II Product Code: ODP Dated: October 23, 2012 Received: October 24, 2012

Dear Ms. Volosen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

{4}------------------------------------------------

Page 2 – Ms. Natalia Volosen

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 11 Jou us.it s opes.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 vours.

# Mark N. Melkerson

Mark N. Melkerson Director · Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known): - K121649

Device Name: CONSTRUX Mini® PEEK Ti Spacer System

Indications for Use:

The CONSTRUX Mini PEEK Ti Spacer System is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.

The CONSTRUX Mini PEEK Ti Spacer System is intended for use with autograft and supplemental fixation system (i.e. anterior cervical plate such as the Orthofix ACP or Hallmark® System).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with the CONSTRUX Mini PEEK Ti Spacer System in the cervical spine.

Prescription Use: X (Part 21 CFR 801 Subpart D) And / Or

Over-The-Counter (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Caroline Rhim -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121649

Page 1 of 1