SeaSpine Mariner Pedicle Screw System

K173882 · SeaSpine Orthopedics Corporation · NKB · Feb 6, 2018 · Orthopedic

Device Facts

• Record ID: K173882
• Device Name: SeaSpine Mariner Pedicle Screw System
• Applicant: SeaSpine Orthopedics Corporation
• Product Code: NKB · Orthopedic
• Decision Date: Feb 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Mariner Pedicle Screw System is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: - degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, - severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion, - spondylolisthesis, - trauma (i.e., fracture or dislocation), - spinal stenosis, - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis). - spinal tumor, - pseudoarthrosis, and/or - failed previous fusion.

Device Story

Non-cervical spinal fixation system; provides posterior pedicle screw, posterior non-pedicle screw, or anterolateral fixation. Components include fixed, polyaxial, and restricted-motion pedicle screws; connecting spinal rods; locking elements. Used in OR by surgeons to immobilize/stabilize spinal segments. Implants facilitate fusion in acute/chronic spinal instabilities or deformities. System includes manual instruments for placement, adjustment, and locking of implants; storage trays/caddies for steam sterilization.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing, including static and dynamic mechanical testing per ASTM F1717 and ASTM F1798.

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V ELI (ASTM F136), Cobalt chrome (ASTM F562, ASTM F1537). Components: Pedicle screws (fixed, polyaxial, restricted-motion), rods, locking elements. Sterilization: Steam. Mechanical testing: ASTM F1717, ASTM F1798.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral spine conditions including DDD, severe spondylolisthesis (L5-S1), trauma, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), spinal tumor, pseudoarthrosis, and failed previous fusion.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• SeaSpine Mariner Pedicle Screw System (K160902)
• SeaSpine Malibu Spinal System (K122571)
• SeaSpine Malibu Spinal System (K072605)
• SeaSpine Malibu Spinal System (K061342)
• SeaSpine Malibu Spinal System (K051942)
• SeaSpine Malibu Spinal System (K051663)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SeaSpine Orthopedics Corporation Gina Flores Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008

Re: K173882

Trade/Device Name: SeaSpine Mariner Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw Systems Regulatory Class: Class II Product Code: NKB Dated: February 2, 2018 Received: February 5, 2018

Dear Gina Flores:

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. Iisting 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 mediation-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.

Colin O'neill -S
for MNM

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)

#### K173882

Device Name SeaSpine Mariner Pedicle Screw System

#### Indications for Use (Describe)

The intended use of the Mariner Pedicle Screw System is to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

- degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,

- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,

- spondylolisthesis,

- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
- spinal tumor,
- pseudoarthrosis, and/or
- failed previous fusion.

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

| <div> <span style="font-size:12pt"> <b> ☑ </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:12pt"> ☐ </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

# Contact Details

| Applicant Name: | SeaSpine Orthopedics Corporation | |
|------------------------------------------|--------------------------------------------------------------------|--|
| Address:<br>Phone number:<br>Fax number: | 5770 Armada Drive, Carlsbad CA<br>[phone]<br>[phone] | |
| Contact person:<br>Email address: | Gina Flores, Sr. Regulatory Specialist<br>[e-mail] | |
| Date Prepared: | December 20, 2017 | |
| <b>Device Name</b> | | |
| Trade Name: | SeaSpine Mariner Pedicle Screw System | |
| Common Name: | Pedicle Screw Spinal System | |
| Classification: | 21 CFR 888.3070 | |
| Classification Name: | Thoracolumbosacral Pedicle Screw | |
| Class: | II | |
| Product Code: | NKB | |

# Legally Marketed Predicate Devices

| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---------------------------------------------------|--------------|------------------------------------------|-------------------------------------|
| PRIMARY PREDICATE Device | | | |
| K160902 | NKB | SeaSpine Mariner<br>Pedicle Screw System | SeaSpine Orthopedics<br>Corporation |
| ADDITIONAL PREDICATE Devices | | | |
| K122571, K072605,<br>K061342, K051942,<br>K051663 | NKB | SeaSpine Malibu Spinal<br>System | SeaSpine Orthopedics<br>Corporation |

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### Device Description

The Mariner Pedicle Screw System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants including fixed, polyaxial, cephalad/caudal restricted-motion, and medial/lateral restricted motion pedicle screws as well as connecting spinal rods and a separate locking element.

The Mariner implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), and cobalt chrome (Co-35Ni-20Cr-10Mo per ASTM F562 and Co-28Cr-6Moalloy 1 (warm worked) per ASTM F1537). The instruments included in the Mariner Pedicle Screw system facilitate the placement, removal, adjustment, and final locking of the system implants. Other accessories to the system also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

### Intended Use/Indications for use

The intended use of the Mariner Pedicle Screw System is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

- degenerative disc disease (DDD) as defined by back pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies
- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature . patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion
- spondylolisthesis .
- trauma (i.e., fracture or dislocation) .
- spinal stenosis .
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- spinal tumor "
- pseudarthrosis, and/or .
- failed previous fusion. .

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## Summary of Technological Characteristics

The SeaSpine Mariner Pedicle Screw System is similar to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical).

All implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and they represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.

## Non-Clinical Testing

The SeaSpine Mariner Pedicle Screw System demonstrated similar performance to the predicate systems through static and dynamic mechanical testing with reference to ASTM F1717 and ASTM F1798.

## Clinical Testing

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

## Conclusions

The submitted data demonstrate that the SeaSpine Mariner Pedicle Screw System is substantially equivalent to the cited legally marketed predicate.