(109 days)
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No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to promote fusion of the cervical spine and the thoracic spine for various conditions like DDD, spondylolisthesis, and fractures, which directly addresses medical disorders.
No
This device is a spinal fixation system intended for surgical implantation to promote fusion and provide stabilization of the spine after various conditions or procedures. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the system consists of physical components like longitudinal members, anchors, transverse connectors, and instruments, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the surgical fixation and stabilization of the spine to promote fusion. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details implants (longitudinal members, anchors, transverse connectors) and instruments for their insertion. These are physical devices used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Nex-Link Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
MNI, KWP
Device Description
The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.
The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior spine. The subject devices share the same intended use and fundamental scientific technology as the predicates.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
cervicothoracic spine (C1-T3), cervical spine, thoracic spine (T1-T3), cervical/upper thoracic (C1-T3) spine
Indicated Patient Age Range
Not Found
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)
Non-Clinical Performance and Conclusions: Laboratory and bench testing results demonstrate that the proposed devices are substantially equivalent to the predicate devices. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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.
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2006 JAN 6
ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS
| SUBMITTER: | Abbott Spine Inc.
(formerly Spinal Concepts, Inc.) |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT REGISTRATION
NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch
Specialist, Regulatory Affairs
Telephone: 512.533.1840
Fax: 512.918.2784 |
| DATE: | September 16, 2005 |
| TRADE NAME: | Nex-Link Spinal Fixation System
Polyaxial Screws, Open Hooks |
| COMMON NAME: | Posterior Spinal Implant |
| CLASSIFICATION NAME: | KWQ: Spinal Intervertebral Body Fixation
Orthosis
MNI: Pedicle Screw Spinal System |
| CLASSIFICATION REFERENCE: | 21 CFR § 888.3050, 888.3070 |
| PREDICATE DEVICE: | Spinal Concepts, Inc. (now Abbott Spine, Inc.)
Nex-Link Spinal Fixation System, K031985,
cleared September 11, 2003. |
DEVICE DESCRIPTION:
The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.
The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior spine. The subject devices share the same intended use and fundamental scientific technology as the predicates.
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