When used as a pedicle screw fixation system, the Nu Vasive Reline System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment
Fracture
Dislocation
Scoliosis
Kyphosis
Spinal tumor and/or
Failed previous fusion (pseudoarthrosis)

The Nu Vasive Reline System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-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:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal stenosis
Spondylolisthesis
Spinal deformities
Fracture
Pseudoarthosis
Tumor resection and/or
Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is 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: 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.

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

Device Description

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. The purpose of this submission is to introduce design modifications to previously cleared components and add iliac saddle to previously cleared Reline System.

AI/ML Overview

This document describes a 510(k) premarket notification for the NuVasive Reline System, a thoracolumbosacral pedicle screw system.

Here's an analysis based on your request, but please note that this type of FDA 510(k) summary typically does not include detailed clinical study data with acceptance criteria, sample sizes, expert qualifications, or MRMC studies for traditional orthopedic implants like pedicle screw systems. Instead, it relies heavily on substantial equivalence to predicate devices and mechanical performance testing.

Therefore, many of the requested points below will be answered with "Not applicable/provided" or explanations about why such details are not present in this type of submission.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Not explicitly stated as such, but inferred from regulatory requirements and predicate comparison for mechanical testing)	Reported Device Performance (as described in the summary)
Mechanical performance equivalent to predicate devices.	Demonstrated substantial equivalence (SE) to predicate devices in areas including design, labeling/intended use, material composition, and function.
Pass relevant ASTM standards for spinal implant systems. (Specifically mentioned ASTM F1798)	ASTM F1798 mechanical testing was performed to evaluate the design modifications, and "engineering rationale was provided to demonstrate that the subject NuVasive Reline System is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided document. The testing seems to be based on mechanical (bench) testing, not patient data.
Data Provenance: Not applicable, as no human data is described. The engineering rationale and mechanical testing would be conducted in a laboratory setting.
Retrospective/Prospective: Not applicable, as no human data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/provided. This device is a mechanical implant, and its performance for 510(k) relies on mechanical testing and substantial equivalence to existing devices, not clinical ground truth established by medical experts in an diagnostic or interpretive sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/provided. As there's no clinical test set with human assessments or interpretations, adjudication methods are not relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/provided. This is a spinal implant, not an AI software/diagnostic device. MRMC studies are not relevant to its 510(k) clearance process described here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/provided. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the clinical sense. The "ground truth" for this type of device typically refers to engineering specifications, material properties, and the performance standards established by predicate devices and ASTM standards, validated through mechanical testing.

8. The sample size for the training set

Not applicable/provided. This refers to the training of an algorithm or AI model, which is not relevant to this device's submission.

9. How the ground truth for the training set was established

Not applicable/provided. This refers to the ground truth for an AI model's training, which is not relevant to this device's submission.

Summary

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February 13, 2019

NuVasive, Incorporated Mr. Joseph De La Rosa Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K182974

Trade/Device Name: NuVasive® Reline® System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: October 25, 2018 Received: October 26, 2018

Dear Mr. De La Rosa:

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 Mav 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. 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 located 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 vou, 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

K182974

Device Name NuVasive® Reline® System

Indications for Use (Describe)

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

1. Degenerative spondylolisthesis with objective evidence of neurologic impairment
1. Fracture
1. Dislocation
1. Scoliosis
1. Kyphosis
1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

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:

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

1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthosis
1. Tumor resection and/or
1. Failed previous fusion

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

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K182974 - Page 1 of 3

Image /page/4/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray letters. The logo is simple and modern, and the colors are muted and professional.

NuVasive® Reline® System February 1, 2019

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Joseph De La Rosa Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 309-3744

Date Prepared: February 1, 2019

B. Device Name

Trade or Proprietary Name:	NuVasive ® Reline ® System
Common or Usual Name:	Pedicle Screw System
Classification Name:	Thoracolumbosacral pedicle screw system
Device Class:	Class II
Classification:	21 CFR § 888.3070
Product Code:	NKB, KWP, KWQ

Predicate Devices C.

The subject device is substantially equivalent to the primary predicate device NuVasive Reline 4.5-5.0 System (K170126) and additional predicate devices, NuVasive Reline (K169089), NuVasive Reline Fenestrated Screws with High V+ Bone Cement (K180498), and Biomet Spine Polaris Spinal System (K151974).

D. Device Description

E. Intended 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)
1. Degenerative spondylolisthesis with objective evidence of neurologic impairment
3.Fracture
1. Dislocation

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Image /page/5/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. The logo is simple and modern, and the colors are muted and professional.

NuVasive® Reline® System February 1, 2019

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

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)
1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
5.Fracture
1. Pseudoarthosis
1. Tumor resection and/or
8.Failed previous fusion

When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System is 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.

In order to achieve additional levels of fixation, the NuVasive 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 predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.

G. Performance Data

Engineering rationale was provided to demonstrate that the subject NuVasive Reline System is substantially equivalent to the predicate device. ASTM F1798 mechanical testing was performed to evaluate the design modifications.

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Image /page/6/Picture/0 description: The image shows the logo for NuVasive. The logo consists of a stylized leaf-like shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is split into two parts, with the top part in purple and the bottom part in gray.

H. Conclusions

The subject NuVasive Reline System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.

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.