(275 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "Posterior Fixation System" intended for conditions like degenerative disc disease, spondylolisthesis, and trauma, used to facilitate fusion, which are all therapeutic interventions for spinal conditions.
No
The device description clearly states it is a "pedicle screw system that consists of pedicle screws, rods, connectors, and set screws" for posterior non-cervical fixation, which are surgical implants used in treatment, not for diagnosis. Its intended use describes conditions it treats, not conditions it diagnoses.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, connectors, and set screws, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The NEX-D2 Posterior Fixation System is a system of implants (screws, rods, connectors) designed to be surgically implanted into the spine for structural support and fusion.
- Intended Use: The intended use is for posterior spinal fixation in patients with various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
The provided information clearly describes a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NEX-D2 Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pediatic patients, the NEX-D2 Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft to facilitate fusion.
Product codes
NKB
Device Description
The Next Orthosurgical NEX-D2 Posterior Fixation System is a non-cervical pedicle screw system that consists of pedicle screws, rods, connectors, and set screws. All components are available in a variety of sizes to match patient anatomy. All components are manufactured from Ti-6AI-4V ELI per ASTM F136, commercially pure titanium per ASTM F67, and cobalt chrome allov per ASTM F1537, These components are supplied either sterile or non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical
Indicated Patient Age Range
skeletally mature patients, pediatric patients (adolescent idiopathic scoliosis)
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)
Mechanical testing was performed on the subject devices in accordance with relevant ASTM Standards listed below with each test mode. Mechanical tests included:
- Static Compression Bending per ASTM F1717
- Dynamic Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717
- Axial Grip Strength per ASTM F1798
- Torsional Grip Strength per ASTM F1798
- Torsional Strength per ASTM F543
- Static Cantilever Bending Strength per ASTM F1798
- Dynamic Cantilever Bending Strength per ASTM F1798
- Static Polyaxial Head Pull off per ASTM F1798
Bacterial endotoxin testing was performed in accordance with ANSI/AAMI ST72.
Testing results demonstrate that the NEX-D2 Posterior Fixation System is substantially equivalent to the predicate devices. The subject devices met the pre-determined acceptance criteria.
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Next Orthosurgical, VertiForm Posterior Fixation System, K141291, Next Orthosurgical, VertiForm Posterior Fixation System, K161499, DePuy Moss Miami Spinal System Polyaxial Screws, K030383, Spinal Elements Mercury Spinal System, K172967
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 15, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Next OrthoSurgical Ms. Sartaj Kaur-Hurrle Regulatory Affairs Manager 3270 Corporate View, Suite A Vista. California 92081
Re: K190981
Trade/Device Name: NEX-D2 Posterior Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: December 20, 2019 Received: December 23, 2019
Dear Ms. Kaur-Hurrle:
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 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
1
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 medical devices and radiation-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,
for
(Ronald Jean) Vacant 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) K190981
Device Name NEX-D2 Posterior Fixation System
Indications for Use (Describe)
The NEX-D2 Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pediatic patients, the NEX-D2 Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft to facilitate fusion.
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.
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."
3
NEXT ORTHOSURGICAL
510(k) Summary
NEX-D2 Posterior Fixation System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the NEX-D2 Posterior Fixation System
1. GENERAL INFORMATION
| Submitted by: | Next OrthoSurgical
3270 Corporate View, Suite A
Vista CA. 92081
760-295-3600 (Tel)
760-295-3610 (Fax) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sartaj Kaur-Hurrle, Regulatory Affairs Manager
3270 Corporate View, Suite A
Vista CA. 92081
760-295-3600 (Tel)
760-295-3610 (Fax)
Email: skaur-hurrle@nextorthosurgical.com |
| Trade Name: | NEX-D2 Posterior Fixation System |
| Common Name: | Pedicle Screw System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Class: | II |
| Product Code: | NKB |
| CFR Section: | 21 CFR 888.3070 |
| Device panel: | Orthopedic |
| Legally Marketed
Predicate Device: | Next Orthosurgical, VertiForm Posterior Fixation System, K141291
(Primary Predicate)
Next Orthosurgical, VertiForm Posterior Fixation System, K161499
DePuy Moss Miami Spinal System Polyaxial Screws, K030383
Spinal Elements Mercury Spinal System, K172967
The predicates have not been subject to a design related recall |
Date Prepared: 1/10/2020
Purpose of Submission
The purpose of this submission is to gain clearance for additional components (line additions) to the NEX-D2 Posterior Fixation System, which is a non-cervical pedicle screw fixation system including hex-end/MIS titanium alloy and cobalt chrome alloy rods, additional large screw sizes, offset connectors, Rod to Rod Connectors and optional instruments.
4
NEXT ORTHOSURGICAL
2. DEVICE DESCRIPTION
The Next Orthosurgical NEX-D2 Posterior Fixation System is a non-cervical pedicle screw system that consists of pedicle screws, rods, connectors, and set screws. All components are available in a variety of sizes to match patient anatomy. All components are manufactured from Ti-6AI-4V ELI per ASTM F136, commercially pure titanium per ASTM F67, and cobalt chrome allov per ASTM F1537, These components are supplied either sterile or non-sterile.
3. INDICATIONS FOR USE
The NEX-D2 Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the NEX-D2 Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and or allograft to facilitate fusion.
4. SUBSTANTIAL EQUIVALENCE
The NEX-D2 Posterior Fixation System is substantially equivalent in indications for use, surgical technique, design features, materials used, mechanical performance, and instrumentation to the following predicate devices: Next Orthosurgical's VertiForm Posterior Fixation System (K141291, K161499), DePuy's Moss Miami Spinal System Polyaxial Screws (K030383) and Spinal Elements Mercury Spinal System (K172967).
5. NON-CLINICAL TEST SUMMARY
Mechanical testing was performed on the subject devices in accordance with relevant ASTM Standards listed below with each test mode. Mechanical tests included:
- Static Compression Bending per ASTM F1717
- Dynamic Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717
- Axial Grip Strength per ASTM F1798
- Torsional Grip Strength per ASTM F1798
- Torsional Strength per ASTM F543
- Static Cantilever Bending Strength per ASTM F1798
- Dynamic Cantilever Bending Strength per ASTM F1798
- Static Polyaxial Head Pull off per ASTM F1798
Bacterial endotoxin testing was performed in accordance with ANSI/AAMI ST72.
Testing results demonstrate that the NEX-D2 Posterior Fixation System is substantially equivalent to the predicate devices. The subject devices met the pre-determined acceptance criteria.
6. CLINICAL TEST SUMMARY
No clinical studies were performed.
5
7. CONCLUSIONS NONCLINICAL AND CLINICAL
Next Orthosurgical considers the NEX-D2 Posterior Fixation System to be substantial equivalent to the predicate devices listed above. This conclusion is based on the device's similarities in principles of operation, technology, materials and indications for use.