NuVasive® Reline® System

When used as a pedicle screw fixation system, the NuVasive Reline System is 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 posterior thoracic, lumbar, and sacral spine:

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

2.Degenerative spondylolisthesis with objective evidence of neurologic impairment

3. Fracture

4. Dislocation

5. Scoliosis

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K161014 - Page 2 of 2

\ NuVasive® Reline ® System
Speed of Innovation September 26, 2016

6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline
System implants are indicated as an adjunct to fusion to treat adolescent idiopathic
scoliosis. Additionally the NuVasive Reline System is intended to treat pediatric patients
diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture
caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior
approach and is intended to be used with autograft and/or allograft.

The NuVasive Reline System is also indicated for the treatment of severe spondylolisthesis
(Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion
by autogenous bone graft, having the device fixed or attached to the lumbar and sacral
spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine,
the NuVasive Reline System is also intended for the following indications:

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

2.Spinal stenosis

3.Spondylolisthesis

4.Spinal deformities

5. Fracture

6. Pseudoarthosis

7.Tumor resection and/or

8. Failed previous fusion

In order to achieve additional levels of fixation, the Reline System rods may be connected
to the Armada System.

F. Technological Characteristics
As was established in this submission, the subject NuVasive Reline System is substantially
equivalent to other

The NuVasive Reline System is a pedicle screw system that consists of a variety screws,
hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and
associated general instruments. Implant components are available in a variety sizes and can
be rigidly locked into a variety of different configurations to suit the individual pathology
and anatomical conditions of the patient. This 510(k) is to introduce sterile packaged
implants to the Reline System.

Indications for Use

When used as a pedicle screw fixation system, the NuVasive Reline System is 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 posterior thoracic, lumbar, and sacral spine:

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

2.Degenerative spondylolisthesis with objective evidence of neurologic impairment

3. Fracture

4. Dislocation

5. Scoliosis

Page | of 2

K161014 - Page 2 of 2

\ NuVasive® Reline ® System
Speed of Innovation September 26, 2016

6. Kyphosis
7. Spinal tumor and/or
8. Failed previous fusion (pseudoarthrosis)

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline
System implants are indicated as an adjunct to fusion to treat adolescent idiopathic
scoliosis. Additionally the NuVasive Reline System is intended to treat pediatric patients
diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture
caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior
approach and is intended to be used with autograft and/or allograft.

The NuVasive Reline System is also indicated for the treatment of severe spondylolisthesis
(Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion
by autogenous bone graft, having the device fixed or attached to the lumbar and sacral
spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine,
the NuVasive Reline System is also intended for the following indications:

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

2.Spinal stenosis

3.Spondylolisthesis

4.Spinal deformities

5. Fracture

6. Pseudoarthosis

7.Tumor resection and/or

8. Failed previous fusion

In order to achieve additional levels of fixation, the Reline System rods may be connected
to the Armada System.

F. Technological Characteristics
As was established in this submission, the subject NuVasive Reline System is substantially
equivalent to other