PCT System

K152211 · Centinel Spine, Inc. · NKG · Dec 1, 2015 · Orthopedic

Device Facts

• Record ID: K152211
• Device Name: PCT System
• Applicant: Centinel Spine, Inc.
• Product Code: NKG · Orthopedic
• Decision Date: Dec 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CENTINEL SPINE PCT SYSTEM is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 CENTINEL SPINE PCT 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.

Device Story

The Centinel Spine PCT System is a posterior cervical/thoracic spinal fixation system. It consists of rods, hooks, polyaxial screws, and cross-connectors. Surgeons implant these components into the posterior elements of the cervical and upper thoracic spine to provide immobilization and stabilization. The system acts as an adjunct to fusion or as a temporary stabilizer for patients with advanced tumors. The device is used in an operating room setting by orthopedic or neurosurgeons. The surgeon uses radiographic imaging to confirm pathology and guide placement. The construct is assembled by securing rods to bone anchors (screws/hooks) using set screws. The system provides mechanical support to the spinal column, potentially reducing pain and restoring stability in patients with degenerative or traumatic spinal conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included static compression, static torsion, dynamic compression, and dynamic torsion per modified ASTM F1717, and axial slip/torsional grip testing per ASTM F1798. Results demonstrated that the device met the performance criteria of the predicate devices.

Technological Characteristics

System components include rods, hooks, polyaxial screws, and cross-connectors. Materials: Titanium alloy (Ti6Al4V) conforming to ASTM F136 or ISO 5832-3. Mechanical fixation via bone anchors and set screws. No software or electronic components.

Indications for Use

Indicated for patients with acute/chronic cervical (C1-C7) and upper thoracic (T1-T3) spinal instabilities, including traumatic fractures/dislocations, deformity, pseudarthrosis, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for temporary spinal column stabilization in patients with advanced cervical tumors where fusion is not expected.

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

• DePuy Synthes Spine Synapse System (K142838)
• Pioneer Surgical Technology Streamline OCT System (K121725)
• Blackstone Posterior Cervical System (K030197)
• Exactech Gibralt Spinal System (K140645, K110197)

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

December 1, 2015

Centinel Spine, Incorporated Ms. Jessica Staub Director, Quality and Regulatory 900 Airport Road, Suite 3B West Chester, Pennsylvania 19380

Re: K152211 Trade/Device Name: Centinel Spine PCT System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: October 28, 2015 Received: October 30, 2015

Dear Ms. Staub:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Jessica Staub

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 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) K152211

Device Name Centinel Spine PCT System

#### Indications for Use (Describe)

The CENTINEL SPINE PCT SYSTEM is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 CENTINEL SPINE PCT 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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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# 4. 510(k) Summary

| Device Trade Name: | Centinel Spine PCT System |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Centinel Spine, Inc.<br>900 Airport Road, Suite 3B<br>West Chester, PA 19380 |
| Contact: | Ms. Jessica Staub<br>Director, Quality and Regulatory<br>Phone: [phone] |
| Prepared by: | Mr. Justin Eggleton<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | October 28, 2015 |
| Classifications: | Unclassified (Pre-Amendment Device) |
| Class: | Unclassified |
| Product Codes: | NKG, KWP |
| Primary Predicate: | DePuy Synthes Spine Synapse System (K142838) |
| Additional Predicates: | Pioneer Surgical Technology Streamline OCT System (K121725)<br>Blackstone Posterior Cervical System (K030197)<br>Exactech Gibralt Spinal System (K140645, K110197) |

## Indications For Use:

The CENTINEL SPINE PCT SYSTEM is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical 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 CENTINEL SPINE PCT 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.

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#### Summary of Technological Characteristics:

The Centinel Spine PCT System consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, and connecting components (e.g., variable and fixed cross connectors). The hooks and polyaxial screws are intended to be attached to the posterior elements of the cervical and/or upper thoracic spine and serve as bone anchors. The rods are longitudinally secured to the bone anchors with the set screw. The various connecting components serve to both secure the construct and provide additional construct configuration options. All implants are manufactured from titanium alloy, Ti6A14V (ASTM F136 or ISO 5832-3)

#### Predicate Device:

The subject Centinel Spine PCT System is substantially equivalent to the predicate devices cited in this 510(k) summary with respect to indications, design, function, and performance.

#### Substantial Equivalence:

Centinel Spine PCT System and the primary predicate DePuy Synthes Spine Synapse OCT system are similar in indications for use, design, material, function, and performance. Additional comparisons were made to alternate predicate devices with the same indications for use, design, material, function, and performance.

#### Performance Testing:

Published literature and performance testing indicates the Centinel Spine PCT System is as mechanically sound as predicate devices. Testing included static compression, static torsion, dynamic compression, and dynamic torsion per a modified version of ASTM F1717. ASTM F1798 testing included axial slip and torsional grip testing. The results demonstrate that the acceptance criteria defined by predicate device performance were met.

## Conclusion:

The purpose of this 510(k) is to introduce the Centinel Spine PCT System to interstate commerce. The 510(k) demonstrates substantial equivalence to the predicate devices cited in this summary.