(92 days)
Not Found
No
The summary describes a mechanical pedicle screw fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are based on mechanical testing standards.
Yes
The device is a pedicle screw fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various acute and chronic instabilities or deformities. These indications clearly point to its function in treating or managing a disease or condition in the body, thus classifying it as a therapeutic device.
No
The device description clearly states it is a "pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments" used for "immobilization and stabilization of spinal segments as an adjunct to fusion," indicating it is a surgical implant for treatment, not a diagnostic tool.
No
The device description explicitly states it consists of physical components like screws, hooks, rods, and connectors, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for stabilizing and immobilizing the spine in patients with various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of screws, hooks, rods, and connectors, which are physical implants used in surgery. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the NuVasive Reline System is a surgical implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments 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 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:
- 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
-
- Pseudoarthrosis
-
- 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.
- progressive spinal deformities (i.e., scoliosis, or lordosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis,
-
- spondylolisthesis,
-
- spondylolysis,
-
- pseudarthrosis,
-
- failed prior fusion and
-
- fracture caused by tumor and/or trauma in pediatric patients.
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.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWQ
Device Description
The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety of 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 "Dual-Headed Modular Connectors" which will be included in the NuVasive Reline System. Additionally, this submission is intended to specify pediatric progressive deformities in the indications for use statement for NuVasive Reline System. Lastly, this submission is intended to add minor labeling changes to address compatibility updates to the NuVasive Reline system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Posterior thoracic, lumbar, and sacral spine; L5-S1 vertebral joint (L3 to sacrum); Anterolateral in the thoracic and lumbar spine; Posterior non-cervical in pediatric patients.
Indicated Patient Age Range
Skeletally mature patients, pediatric patients (adolescent, infantile, and juvenile).
Intended User / Care Setting
Prescription Use
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)
Nonclinical testing was performed to demonstrate that the subject NuVasive Reline System is substantially equivalent to the predicate device. The following testing was performed:
- Static Compression Bending Testing per ASTM F1717-21
- Dynamic Compression Bending Testing per ASTM F1717-21
The results demonstrate that the subject NuVasive Reline System is substantially equivalent to the predicate.
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.
CD Horizon™ Spinal System (K211958), NuVasive Reline 4.5-5.0 System (K190636), GSB Global Spinal Balance System (K132014)
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
§ 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.
0
January 11, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
NuVasive, Incorporated Bland Tanesha Sr. Regulatory Affairs Specialist 7475 Lusk Blvd San Diego, California 92121
Re: K223181
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, KWQ Dated: October 10, 2022 Received: October 11, 2022
Dear Bland Tanesha:
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. 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 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
1
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/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 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 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
Colin O'Neill, M.B.E. 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
2
Indications for Use
510(k) Number (if known) K223181
Device Name NuVasive Reline System
Indications for Use (Describe)
When used as a pedicle screw fixation system in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments 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 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:
- 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
-
- Pseudoarthrosis
-
- 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.
- progressive spinal deformities (i.e., scoliosis, or lordosis) including infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis,
-
- spondylolisthesis,
-
- spondylolysis,
-
- pseudarthrosis,
-
- failed prior fusion and
-
- fracture caused by tumor and/or trauma in pediatric patients.
Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
3
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray, sans-serif font. The leaf shape is on the left side of the logo, and the word "NUVASIVE" is on the right side.
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.
Tanesha Bland Sr. Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (323)683-5714
Date Prepared: October 10, 2022
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 |
C. Predicate Devices
The subject device is substantially equivalent to the primary predicate device CD Horizon™ Spinal System (K211958) and additional predicate devices, NuVasive Reline 4.5-5.0 System (K190636) and GSB Global Spinal Balance System (K132014).
D. Device Description
The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Implant components are available in a variety of 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 "Dual-Headed Modular Connectors" which will be included in the NuVasive Reline System. Additionally, this submission is intended to specify pediatric progressive deformities in the indications for use statement for NuVasive Reline System. Lastly, this submission is intended to add minor labeling changes to address compatibility updates to the NuVasive Reline system.
E. Indications for Use
When used as a pedicle screw fixation system in skeletally mature patients, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments 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:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
5
Image /page/5/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf shape is purple on the top and gray on the bottom.
-
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
-
- Fracture
-
- Dislocation
-
- Scoliosis
-
- Kyphosis
-
- Spinal tumor and/or
-
- 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:
-
- 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 2.
-
- Spondylolisthesis
-
- Spinal deformities
-
- Fracture
-
- Pseudoarthrosis
- Tumor resection and/or 7.
-
- 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.
- progressive spinal deformities (i.e., scoliosis, or lordosis) including 2. infantile and juvenile idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis,
- spondylolisthesis. 3.
-
- spondylolysis,
-
- pseudarthrosis,
-
- failed prior fusion and
-
- fracture caused by tumor and/or trauma in pediatric patients.
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
6
Image /page/6/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. The leaf shape is on the left side of the logo, and the word "NUVASIVE" is on the right.
equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NuVasive Reline System is substantially equivalent to the predicate device. The following testing was performed:
- Static Compression Bending Testing per ASTM F1717-21 ●
- . Dynamic Compression Bending Testing per ASTM F1717-21
The results demonstrate that the subject NuVasive Reline System is substantially equivalent to the predicate.
H. Conclusions
The subject NuVasive Reline System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.