(27 days)
Not Found
No
The document describes a mechanical spinal fixation system and explicitly states that AI, DNN, or ML were not found in the description.
Yes
The device is a spinal fixation system intended to promote fusion and provide stabilization in the cervical and thoracic spine, which are therapeutic actions for conditions like DDD, spinal stenosis, fracture, and tumors.
No
The device is a spinal fixation system, indicated for promoting fusion and providing stabilization in the cervical and thoracic spine. It is an implant used for treatment, not for diagnosing medical conditions.
No
The device description explicitly states the system consists of "longitudinal members, 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 states the device is for "promoting fusion of the cervical spine and the thoracic spine" and providing "stabilization to promote fusion." This describes a surgical implant used in vivo (within the body) for structural support and stabilization.
- Device Description: The description details components like "longitudinal members, connectors, and instruments for inserting and securing the implants." These are typical components of a surgical fixation system, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the characteristics associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is a spinal fixation system, which is a type of surgical implant.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-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 DDD (neck pain of discogeme oright my spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and rods are also intended to provide stabilization to promote fusion following Hooks and rous are uiso intentiou to 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 The use of 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 The Nox Emic Spine (C1-T3). The system consists of a series of longitudinal members, ecerviconomics (Sectors, and instruments for inserting and securing the implants.
The subject device, the Variable Crosslink, represents a design modifications made to the The subject device, the Nations or others. The subject device shares the same intended use and fundamental scientific technology as the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, thoracic spine (C1-T3)
Indicated Patient Age Range
Not Found
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)
NON-CLINICAL PERFORMANCE AND CONCLUSIONS: Laboratory and bench testing results demonstrate that the proposed device is substantially equivalent to the predicate device.
CLINICAL PERFORMANCE AND CONCLUSIONS: Clinical data and conclusions were not needed for this device.
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.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
ABBOTT SPINE, INC. SUMMARY OF SAFETY AND EFFECTIVENESS
| SUBMITTER: | Abbott Spine (formerly Spinal Concepts, Inc.) |
|---|---|
| ESTABLISHMENT REGISTRATION | |
| NUMBER: | 1649384 |
| CONTACT PERSON: | Noah Bartsch |
| Specialist, Regulatory Affairs | |
| Telephone: 512.533.1840 | |
| Fax: 512.918.2784 | |
| DATE: | August 17, 2005 |
| TRADE NAME: | Nex-Link Spinal Fixation System Variable |
| Crosslink | |
| 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 The Nox Emic Spine (C1-T3). The system consists of a series of longitudinal members, ecerviconomics (Sectors, and instruments for inserting and securing the implants.
The subject device, the Variable Crosslink, represents a design modifications made to the The subject device, the Nations or others. The subject device shares the same intended use and fundamental scientific technology as the predicate.
INDICATIONS:
INDICATIONS:
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:
1
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and DDD (neck pain of discogeme origin with degeneratives et eture, dislocation, failed previous fusion and/or tumors.
Hooks and rods are also intended to provide stabilization to promote fusion following reduction TIORS and Tods are arso intended we 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 use of maniantal betern is timended to be placed in the cervical spine.
| COMPARISON TO PREDICATE DEVICE: | The subject device is the result of design
modifications to the predicate device, has the same
intended use, and is substantially equivalent to the
predicate device. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE DATA (NONCLINICAL
AND/OR CLINICAL): | NON-CLINICAL PERFORMANCE AND CONCLUSIONS: |
| | Laboratory and bench testing results demonstrate
that the proposed device is substantially equivalent
to the predicate device. |
| | CLINICAL PERFORMANCE AND CONCLUSIONS: |
| | Clinical data and conclusions were not needed for
this device. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Noah Bartsch Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727
Re: K052247
Trade Name: Nex-Link™ Spinal Fixation System Variable Crosslink Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: II Product Code: MNI, KWP Dated: August 17, 2005 Received: August 18, 2005
Dear Mr. Bartsch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the Medical Device Amendments, or to conninered prior to ria) 2011-07-12 in accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmetic For (110) and the device, subject to the general controls provisions of the Act. The r ou may, dierelore, manner of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is elassified (vor a controls. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 loase oc advised that 1 Dr b resumerat your device complies with other requirements of the Act that IDA has made a acternmentations administered by other Federal agencies. You must of ally if cach statutes and regarations sincluding, but not limited to: registration and listing (21 Comply with an the Act 81 equinements, and manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Bartsch
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieting your manieting of your device to a legally premarket notification: "The PDF intentig gour 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 If you desire specific advice for your as (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Complanes as (est notification" (21CFR Part 807.97). You may obtain Misoraliums by releveloc to premanse robilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Car Mark N. Melkerson Acting 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): K052247
Device Name: Nex-Link™ Spinal Fixation System
Indications for Use:
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-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 DDD (neck pain of discogeme oright my spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and rods are also intended to provide stabilization to promote fusion following Hooks and rous are uiso intentiou to 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 The use of 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of General, Resund and Neurological Devices
Page 1 of 1
510(k) Number K052247