Proficient® Posterior Cervical Spine System

K172594 · Spine Wave, Inc. · NKG · Dec 15, 2017 · Orthopedic

Device Facts

• Record ID: K172594
• Device Name: Proficient® Posterior Cervical Spine System
• Applicant: Spine Wave, Inc.
• Product Code: NKG · Orthopedic
• Decision Date: Dec 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Proficient® Posterior Cervical Spine System is intended to immobilize the spine as an adjunct to fusion for cervical (C1-C7) and thoracic (T1- T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios and degenerative disease of the facets with instability. The Proficient® Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient® Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient® transition rods.

Device Story

Proficient® Posterior Cervical Spine System is a spinal fixation system consisting of polyaxial screws, locking screws, rods, and connectors. Used by surgeons in clinical settings to stabilize cervical and thoracic spinal segments. Device components are implanted to provide mechanical immobilization during fusion or temporary stabilization for advanced tumors. System allows for connection to CapSure® or Sniper® systems via transition rods to extend fixation levels. Provides structural support to the spinal column; aids in correcting deformities and managing degenerative conditions.

Clinical Evidence

Bench testing only. Performance data includes dynamic axial compression bend testing, dynamic torsional testing, and static and axial grip testing.

Technological Characteristics

Non-sterile, single-use components. Materials: Titanium (ASTM F136, ASTM F67) and cobalt-chrome alloys (ASTM F1537, ASTM F1058). System includes polyaxial screws, locking screws, rods, and connectors. Mechanical fixation system; no software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion for cervical (C1-C7) and thoracic (T1-T3) segments. Conditions include traumatic fractures/dislocations, instability/deformity, failed fusions, tumors, and degenerative diseases (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for temporary stabilization in patients with advanced cervical tumors where fusion is not feasible.

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

• Proficient® Posterior Cervical Spine System (K162639)
• Lineum OCT Spine System (K151224)
• Synapse OCT System (K142838)

Reference Devices

• CapSure® Spine System
• Sniper® Spine System

Submission Summary (Full Text)

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December 15, 2017

Spine Wave, Inc. Ms. Amy Noccioli Regulatory Affairs Specialist Three Enterprise Drive. Suite 210 Shelton, Connecticut 06484

Re: K172594

Trade/Device Name: Proficient® Posterior Cervical Spine System Regulatory Class: Unclassified Product Code: NKG Dated: November 21, 2017 Received: November 22, 2017

Dear Ms. Noccioli:

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 (OS) 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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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ronald P. Jean – *S* for

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) K172594

#### Device Name

Proficient® Posterior Cervical Spine System

#### Indications for Use (Describe)

The Proficient® Posterior Cervical Spine System is intended to immobilize the spine as an adjunct to fusion for cervical (C1-C7) and thoracic (T1- T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radios and degenerative disease of the facets with instability. The Proficient® Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient® Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient® transition rods.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the words "Spine Wave" in a bold, sans-serif font. The words are arranged horizontally, with "Spine" on the left and "Wave" on the right. A blue wave design is underneath the word "Wave". The text is black.

# 510(k) Summary Proficient® Posterior Cervical Spine System

## 1. Submitter Information

| Submitter: | Spine Wave, Inc. |
|----------------|----------------------------------------------------------|
| Address: | Three Enterprise Drive<br>Suite 210<br>Shelton, CT 06484 |
| Telephone: | 203-712-1842 |
| Telefax: | 203-944-9493 |
| Contact: | Amy Noccioli |
| Date Prepared: | November 21, 2017 |

## 2. Device Information

| Trade Name: | Proficient® Posterior Cervical Spine System |
|----------------------|--------------------------------------------------|
| Common Name: | Posterior Cervico-Thoracic Fixation system |
| Classification: | Unclassified, Pre-Amendment |
| Classification Name: | Orthosis, Cervical Pedicle Screw Spinal Fixation |
| Classification Code: | NKG |

### 3. Purpose of Submission

The purpose of this submission is to gain clearance for the addition of new variations of connectors and polyaxial screws to the previously cleared Proficient® Posterior Cervical Spine System and to expand the indications for use to C1.

### 4. Predicate Device Information

The Proficient® Posterior Cervical Spine System described in this submission is substantially equivalent to the following predicates:

| Primary Predicate Device | Manufacturer | 510(k) No. |
|---------------------------------------------|------------------|------------|
| Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | K162639 |
| Additional Predicate Devices | Manufacturer | 510(k) No. |
| Lineum OCT Spine System | Biomet | K151224 |
| Synapse OCT System | Synthes | K142838 |

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#### 5. Device Description

The subject Proficient® Posterior Cervical Spine System consists of a selection of non-sterile, single-use polyaxial screws, locking screws, rods, and connectors manufactured from titanium per ASTM F136 and ASTM F67 and cobalt-chrome allovs per ASTM F1537 and ASTM F1058. The rods, screws, and connectors are attached to the cervicothoracic spine of skeletally mature patients to stabilize the spine during fusion of vertebral bodies.

### 6. Indications for Use

The Proficient® Posterior Cervical Spine System is intended to immobilize and stabilize the spine as an adjunct to fusion for cervical (C1-C7) and thoracic (T1-T3) spinal segments that have been affected by the following acute or chronic instabilities: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative diseases, 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 Proficient® Posterior Cervical Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine whose life expectancy is insufficient to permit achievement of fusion. In order to achieve additional levels of fixation, the Proficient® Posterior Cervical Spine System may be connected to the CapSure® Spine System or the Sniper® Spine System using the Proficient® transition rods.

### 7. Comparison of Technological Characteristics

The subject Proficient® Posterior Cervical Spine System has technological characteristics similar to those of the predicates, including intended use and indications for use, performance, design, and material composition.

#### 8. Performance Data

Spine Wave, Inc. performed dynamic axial compression bend testing, dynamic torsional testing, and static and axial grip testing to demonstrate substantial equivalence.

#### 9. Conclusion

The indications for use, technological characteristics, and performance data show that the subject Proficient® Posterior Cervical Spine System is substantially equivalent to the predicates identified in this submission, and does not present any new issues of safety or effectiveness.