Centurion POCT System

K150822 · Orthofix, Inc. · NKG · May 15, 2015 · Orthopedic

Device Facts

• Record ID: K150822
• Device Name: Centurion POCT System
• Applicant: Orthofix, Inc.
• Product Code: NKG · Orthopedic
• Decision Date: May 15, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Centurion POCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

Device Story

Centurion POCT System is a temporary, non-sterile, single-use spinal implant construct; components include rods, set screws, cross connectors, multi-axial screws, hooks, occipital plates, bone screws, and cables. Constructed from titanium or cobalt chrome alloys. Used by surgeons in clinical settings to provide spinal immobilization and stabilization. System can be linked to Orthofix Spinal Fixation System via axial or parallel rod connectors. Provides structural support to the spinal column; aids in fusion or restores integrity in palliative tumor cases. Surgeon selects and assembles components intraoperatively to match patient anatomy and pathology.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by mechanical testing per ASTM F1717 and F2706 (static/dynamic compression bending; static/dynamic torsion) and review of published literature.

Technological Characteristics

System components: rods, set screws, cross connectors, multi-axial screws, hooks, occipital plates, bone screws, cables. Materials: Titanium alloy or Cobalt Chrome alloy. Mechanical testing standards: ASTM F1717, ASTM F2706. Non-sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients with acute/chronic instabilities of craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3) requiring immobilization as an adjunct to fusion. Includes traumatic fractures/dislocations, instability/deformity, pseudoarthrosis, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in patients with advanced cervical tumors with limited life expectancy where fusion is not achievable.

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

• Synapse Occipital-Cervical Thoracic (OCT) System (K142838)

Reference Devices

• Centurion POCT System (K131833)

Submission Summary (Full Text)

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

May 15, 2015

Orthofix, Incorporated Ms. Jacki Geren Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K150822 Trade/Device Name: Centurion POCT System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: March 26, 2015 Received: March 27, 2015

Dear Ms. Geren:

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 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.

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Page 2 - Ms. Jacki Geren

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K150822

Device Name Centurion POCT System

#### Indications for Use (Describe)

The Centurion POCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span></span> | <span></span> |
| <div></div> | <div></div> |
| <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## 510(k) SUMMARY

### Centurion POCT System

| 510(k) Owner Information<br>Name:<br>Address: | Orthofix Inc.<br>3451 Plano Parkway<br>Lewisville, TX 75056 |
|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:<br>Fax Number:<br>Email: | 214-937-2100<br>214-937-3322<br>[e-mail] |
| Registration Number: | 3008524126 |
| Contact Person: | Jacki Geren Regulatory Affairs Specialist, II |
| Date Prepared: | March 26, 2015 |
| Name of Device<br>Trade Name / Proprietary<br>Name: | Centurion POCT System |
| Common Name: | Posterior, Cervical Pedicle Screw Spine Fixation<br>Spinal Interlaminal Fixation Orthosis<br>Posterior Cervical System Instrumentation |
| Product Code: | Posterior, Cervical Pedicle Screw Spine Fixation Orthopaedic<br>and Rehabilitation Devices Panel Unclassified; Pre-Amendment<br>Device<br>Product Code: NKG<br>Appliance, Fixation, Spinal Interlaminal<br>Orthopaedic and Rehabilitation Devices Panel<br>Class 2 per 21 CFR 888.3050<br>Product Code: KWP |
| Regulatory Classification: | Unclassified |
| Review Panel: | Orthopedic Device Panel |
| Primary Predicate Devices: K142838 – Synapse Occipital-Cervical Thoracic (OCT)<br>System - Synthes USA Products, LLC | |
| Reference Device: | Centurion POCT System (K131833) |
| Reason for 510(k) Submission: | Expanded Indications for Use |

### Device Description

The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium alloy or Cobalt Chrome

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alloy, that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, cross connectors, parallel and axial connectors, lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.

### Intended Use / Indications for Use

The Centurion POCT System is intended to provide immobilization and stabilization of spinal seqments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 -T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

### Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices

The technological characteristics of the Centurion POCT System are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the predicate device Synapse Occipital-Cervical-Thoracic (OCT) System (K142838) which would adverselv affect the use of the product. The addition of the use of posterior screws in the cervical region of the spine to the Centurion POCT System (K131833) indication does not raise new types of safety and effectiveness questions (risks) not seen before. The same risks occur in the subject Centurion POCT System (K131833) as in the predicate device Synapse Occipital-Cervical-Thoracic (OCT) System (K142838).

### PERFORMANCE DATA

There have been no design changes made to the Centurion POCT System (K131833) implants. The purpose of this 510(k) submission is to obtain clearance for the added indication of use of posterior screws in the cervical region of the spine to the Centurion POCT System (K131833). Published literature and mechanical testing per ASTM F1717 & F2706 (static/dynamic compression bending; static/dynamic torsion) demonstrate that the Centurion POCT System is substantially equivalent.

### Basis of Substantial Equivalence

The Centurion POCT System (K131833) have the same intended use, similar indications for use, similar technological characteristics and design, same materials and the same principles of operation as the predicate device Synapse Occipital-Cervical-Thoracic (OCT) System (K142838).