(22 days)
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functions.
Yes
Explanation: The device is indicated for promoting fusion and providing stabilization in the spine to address various spinal conditions, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a spinal fixation system, which is an implant used to stabilize the spine and promote fusion. It is a treatment device, not a diagnostic one. The provided text describes its intended use for promoting fusion and stabilizing the spine in specific conditions, but it does not mention any diagnostic capabilities or functions.
No
The device description explicitly states it consists of "longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants," which are physical hardware components.
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 device used for the surgical fixation and stabilization of the spine to promote fusion. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details implants (longitudinal members, anchors, transverse connectors) and instruments for their insertion and securing. 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, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the NexLink Spinal Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the NexLink 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
KWQ, MNI
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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervicothoracic spine (C1-T3)
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 safe and effective in use as intended, in accordance with the indications for use of the Nex-Link System.
CLINICAL PERFORMANCE AND CONCLUSIONS: Clinical data and conclusions were not needed for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Koro634
MAR 3 1 2006
ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS
| SUBMITTER: | Abbott Spine, Inc. |
|---|---|
| ESTABLISHMENT REGISTRATION | |
| NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch |
| Senior Specialist, Regulatory Affairs | |
| Telephone: | |
| 512.533.1840 | |
| Fax: | |
| 512.918.2784 | |
| DATE: | March 6, 2006 |
| TRADE NAME: | Nex-Link Spinal Fixation System |
| Rod to Rod Connectors | |
| 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: | The Nex-Link Spinal Fixation System, K052566, |
| cleared on January 6, 2006. |
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.
INDICATIONS:
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the NexLink 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.
1
Hooks and rods are also intended to provide stabilization to promote fusion following reduction rf 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.
| COMPARISON TO PREDICATE DEVICE: | The subject devices are the result of design
modifications to the predicate devices; they have
the same intended use and are substantially
equivalent to the predicate devices. |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE DATA (NONCLINICAL
AND/OR CLINICAL): | NON-CLINICAL PERFORMANCE AND CONCLUSIONS:
Laboratory and bench testing results demonstrate
that the proposed devices are safe and effective in
use as intended, in accordance with the indications
for use of the Nex-Link System. |
| | CLINICAL PERFORMANCE AND CONCLUSIONS: |
Clinical data and conclusions were not needed for this submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular pattern.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2006
Abbott Spine, Inc. c/o Mr. Noah Bartsch Senior Specialist, Regulatory Affairs 5301 Riata Park Court, Building F Austin, Texas 78727
Re: K060634
Trade/Device Name: Nex-Linx™ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, KWQ Dated: March 6, 2006 Received: March 9, 2006
Dear Mr. Bartsch:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 vour 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Noah Bartsch
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Nex-Link™ Spinal Fixation System
Indications for Use:
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the NexLink 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Office of Device Evaluation (ODE) Concurrence
elgmall
Division of General, Restorative. and Neurological Devices
510(k) Number_ko6 06 34
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