K Number
K150822
Device Name
Centurion POCT System
Manufacturer
Date Cleared
2015-05-15

(49 days)

Product Code
Regulation Number
888.3075
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 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.
More Information

No
The description focuses on the mechanical components of a spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.

Yes
The Centurion POCT System is explicitly described as providing immobilization of spinal segments as an adjunct to fusion for various acute and chronic instabilities and conditions, including traumatic spinal fractures, instability, tumors, and degenerative disease. Its intended use is to treat or alleviate these medical conditions, which aligns with the definition of a therapeutic device.

No

The device description clearly states it is a "temporary, multiple component system comprised of a variety of non-sterile, single use components...that allow the surgeon to build a spinal implant construct" and provides specific components like rods, screws, and hooks. This indicates it is an implant used for structural support and immobilization, not for diagnosing a condition.

No

The device description explicitly states it is a "multiple component system comprised of a variety of non-sterile, single use components made of Titanium alloy or Cobalt Chrome alloy," listing various hardware components like rods, screws, and plates. This clearly indicates it is a hardware-based medical device, not software-only.

Based on the provided information, the Centurion POCT System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states that the device is for the immobilization of spinal segments as an adjunct to fusion for various spinal instabilities and conditions. This is a surgical implant used directly on the patient's body.
  • Device Description: The device is described as a multiple component system comprised of rods, screws, connectors, etc., made of Titanium or Cobalt Chrome alloy. These are physical implants.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used outside the body to analyze samples and provide diagnostic information. The Centurion POCT System is a surgical implant used inside the body for structural support and stabilization.

N/A

Intended Use / Indications for 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.

Product codes

NKG, KWP

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K142838

Reference Device(s)

K131833

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3075 Posterior cervical screw system.

(a)
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.(b)
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.

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Centurion POCT System

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

4

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).