K Number

Device Name

NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System

Manufacturer

SeaSpine Orthopedics Corporation

Date Cleared

2024-04-19

(239 days)

Product Code

NKB KWP KWQ MNH MNI PGM

Regulation Number

888.3070

Intended Use

NewPort Spinal System: The NewPort Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, 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. Daytona Small Stature Spinal System: The Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of 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; spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the Daytona Small Stature Spinal System may be used for the above indications as an adjunct to fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is also indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The Daytona Small Stature Spinal System can be attached to other cleared SeaSpine posterior fixation systems (e.g., Atoll OCT, Sierra, Malibu, Daytona, and Mariner Spinal Systems) using the rod connectors. Refer to the package inserts for the indications for use for those systems. Daytona Small Stature Growth Rod Conversion Set: The Daytona Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The extended axial connectors may be used with any cleared Daytona Small Stature Spinal System rod construct. The Daytona Small Stature Growth Rod Conversion Set is not intended to be used in conjunction with staples. Malibu Spinal System (including with the Daytona Deformity System): The intended use of the Malibu Spinal System. when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device 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, 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. The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and 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, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. Mariner Pedicle Screw System, Mariner MIS Pedicle Screw System, Mariner Deformity System, and Mariner RDX System: The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach 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, 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. Mariner Outrigger Revision System: When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Systems: The Mariner Outrigger Revision System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/ilium) in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis (i.e., failed previous fusions). When used with Daytona Small Stature Spinal System for posterior non-cervical pedicle screw fixation in pediatric patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Mariner Outrigger Revision System is intended to be used with autograft.

Device Description

NewPort Spinal System: The NewPort Spinal System. which consists of non-sterile pedicle screws. locking caps, rods. and cap/rod combos, is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The implants are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136), with the screws having a cobalt washer (Co-28Cr-6Mo per ASTM F1537). Daytona Small Stature Spinal System: The Daytona Small Stature Spinal System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, as a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants, including monoaxial, and uniplanar screws, rods, locking caps, crossbars, hooks, and connectors. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562). Daytona Small Stature Growth Rod Conversion Set: The Daytona Small Stature Growth Rod Conversion Set is a non-cervical spinal device intended to convert a traditional fusion construct into a non-fusion, growth- enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The system consists of single use extended axial connectors designed to interact with constructs consisting of hooks, screws, connectors, and rods. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). Malibu Spinal System (including with the Daytona Deformity System): The Malibu Spinal System, which consists of non-sterile implants and the associated instruments, is used to build constructs within the body to act as temporary or permanent posterior, non-cervical spinal fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The system consists of a variety of titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome allov (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) implants. including uni-planar and polyaxial pedicle screws, rods, locking caps, hooks, connectors, crossbars, set screws, and sublaminar wire. Mariner Pedicle Screw System: The Mariner Pedicle Screw System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, a posterior nonpedicle fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The Mariner Pedicle Screw System includes a variety of non-sterile implants manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of fixed, uni-axial, uni-planar, polyaxial, and motion-limiting modular pedicle screws, as well as connecting spinal rods, hooks, connectors, crossbars, and a separate locking element. The Mariner Pedicle Screw System is comprised of several sub-systems whose components are compatible with one another and may be designed for use together, depending on the type of procedure and surgical approach. The sub-systems are as follows: Mariner Outrigger Revision System: The Mariner Outrigger Revision System is a thoracolumbar revision system designed to help reduce the trauma associated with revision surgeries by allowing the user the option to leave the existing hardware in and extend the construct or remove and replace with new SeaSpine hardware. The system includes closed polyaxial heads, Z-rods, and a variety of connectors, including axial, parallel, and L-shaped connectors. The Mariner Outrigger Revision System is compatible with other SeaSpine posterior spinal fixation systems (e.g., Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems) which offer titanium and/or cobalt chrome alloy rods ranging in sizes from Ø4.5mm to Ø6.35mm. Mariner MIS Pedicle Screw System: The Mariner MIS Pedicle Screw System includes instruments and implants designed to facilitate the placement of the Mariner system through a minimally invasive surgical approach. providing an additional surgical approach option for surgeons. The system includes additional rods and extended tab modular screw heads that provide access for instrumentation and implant placement via a minimally invasive surgical approach. Mariner Deformity System: The Mariner Deformity System provides additional implants and instruments designed to expand the functionality of Mariner to address adult deformity applications. The system is comprised of a range of implants, such as pre-contoured and constrained rods, uni-planar, uni-axial, and fenestrated screws, hooks, lateral connectors, and modular screw heads, including those with a rigidly attached rod connector, as well as instruments for pedicle subtraction osteotomy, iliac fixation, reduction, derotation, and correction. Mariner RDX System: The Mariner RDX System provides additional implants and instruments that are designed to facilitate implant-based reduction techniques with an open or minimally invasive approach. The system is comprised of a locking cap and a variety of standard tab, extended tab, and MIS screw heads, as well as associated instruments.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K222110, K200381, K193224

Reference Devices

What you provided for the "Reference Device(s)" field was "Not Found". It means there were no reference devices directly listed in the text.

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a system of spinal implants and instruments for surgical fixation and fusion. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies listed are related to material properties and MRI compatibility, not algorithmic performance.

Therapeutic

Yes.
These devices are explicitly stated to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, and deformities, which directly addresses medical conditions.

Diagnostic

Explanation: The devices described are spinal systems, which are implants and instruments used for stabilization and fusion of spinal segments. Their purpose is therapeutic (to correct spinal disorders and provide stabilization), not diagnostic (to identify or detect a disease or condition).

SaMD (Software as a Medical Device)

The device description clearly states that the system consists of physical implants such as screws, rods, locking caps, and other hardware components made from titanium and cobalt chrome alloys. This indicates it is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
Device Description and Intended Use: The descriptions and intended uses clearly state that these are implantable spinal fixation systems designed to provide mechanical support and stabilization to the spine. They are used in the body during surgery, not to test samples from the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.

The device is a surgical implant used to treat structural issues of the spine.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

NewPort Spinal System

The NewPort Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:

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

· 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.

Daytona Small Stature Spinal System

The Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of 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; spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the Daytona Small Stature Spinal System may be used for the above indications as an adjunct to fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is also indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Daytona Small Stature Spinal System can be attached to other cleared SeaSpine posterior fixation systems (e.g., Atoll OCT, Sierra, Malibu, Daytona, and Mariner Spinal Systems) using the rod connectors. Refer to the package inserts for the indications for use for those systems.

Daytona Small Stature Growth Rod Conversion Set

The Daytona Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The extended axial connectors may be used with any cleared Daytona Small Stature Spinal System rod construct. The Daytona Small Stature Growth Rod Conversion Set is not intended to be used in conjunction with staples.

Malibu Spinal System (including with the Daytona Deformity System)

The intended use of the Malibu Spinal System. when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device 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,

· 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.

The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and 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,

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

Mariner Pedicle Screw System, Mariner MIS Pedicle Screw System, Mariner Deformity System, and Mariner RDX System

The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach 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,

· 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.

Mariner Outrigger Revision System

When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Systems: The Mariner Outrigger Revision System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/ilium) in the treatment of the following acute and chronic instabilities or deformities: · degenerative disc disease (defined as discogenic back pain with degeneration of the disc

confirmed by history and radiographic studies),

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

When used with Daytona Small Stature Spinal System for posterior non-cervical pedicle screw fixation in pediatric patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.

The Mariner Outrigger Revision System is intended to be used with autograft.

Product codes (comma separated list FDA assigned to the subject device)

NKB, KWP, KWQ, PGM

Device Description

NewPort Spinal System

The NewPort Spinal System, which consists of non-sterile pedicle screws. locking caps, rods. and cap/rod combos, is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The implants are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136), with the screws having a cobalt washer (Co-28Cr-6Mo per ASTM F1537).

Daytona Small Stature Spinal System

The Daytona Small Stature Spinal System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, as a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants, including monoaxial, and uniplanar screws, rods, locking caps, crossbars, hooks, and connectors. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562).

Daytona Small Stature Growth Rod Conversion Set

The Daytona Small Stature Growth Rod Conversion Set is a non-cervical spinal device intended to convert a traditional fusion construct into a non-fusion, growth- enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The system consists of single use extended axial connectors designed to interact with constructs consisting of hooks, screws, connectors, and rods. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

Malibu Spinal System (including with the Daytona Deformity System)

The Malibu Spinal System, which consists of non-sterile implants and the associated instruments, is used to build constructs within the body to act as temporary or permanent posterior, non-cervical spinal fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The system consists of a variety of titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome allov (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) implants. including uni-planar and polyaxial pedicle screws, rods, locking caps, hooks, connectors, crossbars, set screws, and sublaminar wire.

Mariner Pedicle Screw System

The Mariner Pedicle Screw System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, a posterior nonpedicle fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur.

The Mariner Pedicle Screw System includes a variety of non-sterile implants manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of fixed, uni-axial, uni-planar, polyaxial, and motion-limiting modular pedicle screws, as well as connecting spinal rods, hooks, connectors, crossbars, and a separate locking element.

The Mariner Pedicle Screw System is comprised of several sub-systems whose components are compatible with one another and may be designed for use together, depending on the type of procedure and surgical approach. The sub-systems are as follows:

Mariner Outrigger Revision System

The Mariner Outrigger Revision System is a thoracolumbar revision system designed to help reduce the trauma associated with revision surgeries by allowing the user the option to leave the existing hardware in and extend the construct or remove and replace with new SeaSpine hardware. The system includes closed polyaxial heads, Z-rods, and a variety of connectors, including axial, parallel, and L-shaped connectors. The Mariner Outrigger Revision System is compatible with other SeaSpine posterior spinal fixation systems (e.g., Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems) which offer titanium and/or cobalt chrome alloy rods ranging in sizes from Ø4.5mm to Ø6.35mm.

Mariner MIS Pedicle Screw System

The Mariner MIS Pedicle Screw System includes instruments and implants designed to facilitate the placement of the Mariner system through a minimally invasive surgical approach. providing an additional surgical approach option for surgeons. The system includes additional rods and extended tab modular screw heads that provide access for instrumentation and implant placement via a minimally invasive surgical approach.

Mariner Deformity System

The Mariner Deformity System provides additional implants and instruments designed to expand the functionality of Mariner to address adult deformity applications. The system is comprised of a range of implants, such as pre-contoured and constrained rods, uni-planar, uni-axial, and fenestrated screws, hooks, lateral connectors, and modular screw heads, including those with a rigidly attached rod connector, as well as instruments for pedicle subtraction osteotomy, iliac fixation, reduction, derotation, and correction.

Mariner RDX System

The Mariner RDX System provides additional implants and instruments that are designed to facilitate implant-based reduction techniques with an open or minimally invasive approach. The system is comprised of a locking cap and a variety of standard tab, extended tab, and MIS screw heads, as well as associated instruments.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic, lumbar, and sacral spine

Indicated Patient Age Range

skeletally mature patients, patients under 10 years of age, pediatric patients

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)

Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
In accordance to the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the following testing was conducted:

ASTM F2052-15 - Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment
ASTM F2213-17 - Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment
ASTM F2119-07 Standard test method for evaluation of MR image artifacts from passive implants
ASTM F2182-19E2 Standard test method for measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging.

Key Results: Not Specified beyond "does not introduce new issues of safety or effectiveness."

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K222110, K200381, K193224

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
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.
(b)
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.

Summary

April 19, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services seal. To the right of the seal is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font. Below that is the word "ADMINISTRATION" in a smaller, non-bold blue font.

SeaSpine Orthopedics Corporation Jacki Koch Regulatory Affairs Program Manager 5770 Armada Drive Carlsbad, Texas 92008

Re: K232566

Trade/Device Name: NewPort Spinal System: Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ, PGM Dated: March 18, 2024 Received: March 18, 2024

Dear Jacki Koch:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin -O'neill -s - L

Colin O'Neill, MBE Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

Submission Number (if known)

K232566

Device Name

NewPort Spinal System;

Daytona Small Stature Spinal System;

Malibu Spinal System;

Mariner Pedicle Screw Systems: Mariner Outrigger Revision System, Mariner MIS Pedicle Screw System, Mariner Deformity System, Mariner RDX System

Indications for Use (Describe) NewPort Spinal System

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

· 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.

Daytona Small Stature Spinal System

Daytona Small Stature Growth Rod Conversion Set

Malibu Spinal System (including with the Daytona Deformity System)

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

· 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.

The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and 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,

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

Mariner Pedicle Screw System, Mariner MIS Pedicle Screw System, Mariner Deformity System, and Mariner RDX System

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,

· 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.

Mariner Outrigger Revision System

confirmed by history and radiographic studies),

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

The Mariner Outrigger Revision System is intended to be used with autograft.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Classification

Add a primary product code and any associated product codes below. You may type in the primary product code directly (only the product code field is required) or you may filter down by choosing first a medical specialty, regulation, then product code. If a device specific quidance is available for the ? product code, the guidance name and web link will be displayed. Use the Product Classification Website resource in the help text to obtain information about your product code and check the regulation text for any special controls that need to be considered (e.g, PAE and 21 CFR 890.3450).

Medical Specialty	Orthopedic
Regulation	888.3070 - Thoracolumbosacral pedicle screw system
Product Code	NKB (Class 2) - Thoracolumbosacral Pedicle Screw System

The primary product code of your device indicates a device specific guidance document is available to aid you in preparing a comprehensive submission. The document entitled "Spinal System 510(k)s - Guidance for Industry and FDA Staff" is available at the link below. If you have any questions about applicability of this guidance, please contact the CDRH review Office.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fdastaff-spinal-system-510ks

Associated Product Code(s)|MNH; MNI; KWP; KWQ; PGM

510(k) SUMMARY

NewPort Spinal System Daytona Small Stature Spinal System Malibu Spinal System Mariner Pedicle Screw System: Mariner Outrigger Revision System Mariner MIS Pedicle Screw System Mariner Deformity System Mariner RDX System

| 510(k) Owner Information
Name:
Address: | SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad, CA 92008, USA |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Email: | 214-937-2100
214-937-3322
jackikoch@orthofix.com |
| Registration Number: | 3012120772 |
| Contact Person: | Jacki Koch |
| Date Prepared: | April 19, 2024 |
| Name of Device
Trade Name / Proprietary
Name: | NewPort Spinal System
Daytona Small Stature Spinal System
Malibu Spinal System
Mariner Pedicle Screw System:
● Mariner Outrigger Revision System
● Mariner MIS Pedicle Screw System
● Mariner Deformity System
● Mariner RDX System |

Common Name:

Spinal Fixation System

Product Code(s):

System Name	Product Codes
NewPort Spinal System	NKB
Daytona Small Stature Spinal System	NKB; KWP; KWQ; PGM
Malibu Spinal System	NKB
Mariner Pedicle Screw Systems	NKB; KWP; KWQ

Classification Name(s)

System Name	Classification Name
-------------	---------------------

NewPort Spinal System	Thoracolumbosacral Pedicle Screw System
Daytona Small Stature Spinal
System
Malibu Spinal System
Mariner Pedicle Screw Systems

Device Classification

System Name	Product Codes
NewPort Spinal System	Class II per 21 CFR § 888.3070
Daytona Small Stature Spinal
System
Malibu Spinal System
Mariner Pedicle Screw Systems

Review Panel:	Orthopedic Device Panel
Primary Predicate Devices:	Mariner Pedicle Screw System: – SeaSpine Orthopedics
Corporation – K222110
• Mariner Outrigger Revision System
• Mariner MIS Pedicle Screw System
• Mariner Deformity System

· Mariner RDX System
Additional Predicate Device: Davtona Small Stature Spinal System - SeaSpine Orthopedics Corporation - K200381, K193224

Reason for 510(k) Submission:

SeaSpine is submitting this Traditional 510(k) premarket notification for the addition of MR Conditional labeling to the subject medical devices.

The subject addition of MR Conditional labeling does not change the design, intended use, materials, performance specifications, or the indications for use as previously cleared.

Device Description

NewPort Spinal System

The NewPort Spinal System. which consists of non-sterile pedicle screws. locking caps, rods. and cap/rod combos, is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur. The implants are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136), with the screws having a cobalt washer (Co-28Cr-6Mo per ASTM F1537).

Daytona Small Stature Spinal System

Daytona Small Stature Growth Rod Conversion Set

Malibu Spinal System (including with the Daytona Deformity System)

Mariner Pedicle Screw System

Mariner Outrigger Revision System

Mariner MIS Pedicle Screw System

Mariner Deformity System

Mariner RDX System

The NewPort Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:

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

Daytona Small Stature Spinal System

The Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of 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; 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.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is also indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Daytona Small Stature Growth Rod Conversion Set

Malibu Spinal System (including with the Daytona Deformity System)

The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device 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,
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.

The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and 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,
spondylolisthesis,
. trauma (i.e., fracture or dislocation),
. spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), ●
. tumor.
pseudoarthrosis, and/or ●
failed previous fusion.

Mariner Pedicle Screw System, Mariner MIS Pedicle Screw System, Mariner Deformity System, and Mariner RDX System

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,
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. ●

Mariner Outrigger Revision System

When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems:

The Mariner Outrigger Revision System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/ilium) in the treatment of the following acute and chronic instabilities or deformities:

. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),
. spondylolisthesis,
trauma (i.e., fracture or dislocation), .

spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), ●
tumor, ●
pseudoarthrosis (i.e., failed previous fusions). ●

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

The Technological Characteristics, design, dimensions, intended use, materials and performance characteristics of the subject devices are unchanged from their previous clearance. The purpose of this 510(k) submission is for the addition of MR Conditional to the device labeling.

PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

In accordance to the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the following testing was conducted:

ASTM F2052-15 - Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment
. ASTM F2213-17 - Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment
ASTM F2119-07 Standard test method for evaluation of MR image artifacts from . passive implants
ASTM F2182-19E2 Standard test method for measurement of radio frequency induced ● heating on or near passive implant during magnetic resonance imaging.

Basis of Substantial Equivalence

As stated throughout this 510(k) notification, there are no modifications to the design, intended use, or indications for use. The purpose of this 510(k) notification is for the addition of MR Conditional labeling for the subject devices.

The subject devices are temporary, multiple component systems comprised of a variety of single use components, made of titanium alloy, commercially pure titanium, or cobalt chrome alloy. There have been no changes to the design, to the material, intended use or indications for use.

Therefore, the subject devices are identical to themselves as previously cleared.

Conclusion

Through performance data, the addition of MR Conditional labeling does not introduce new issues of safety or effectiveness. All subject devices are substantially equivalent to the identified predicate device as there are no modifications to the design, intended use, or indications for use of the subject devices.