(113 days)
EBI® SpineLink™ System, EBI® Omega 21™ System, Webb-Morley Spine System
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a spinal fixation system intended to provide immobilization and stabilization of spinal segments, acting as an adjunct to fusion for treating various spinal conditions and deformities. This aligns with the definition of a therapeutic device designed to treat or alleviate a disease or condition.
No
The device is described as a spinal fixation device intended for immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of various spinal conditions. It does not mention any function related to diagnosing diseases or conditions.
No
The device description explicitly lists physical components such as "interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties," indicating it is a hardware-based medical device.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The EBI® SpineLink™ - II Spinal Fixation System is a physical implant used to stabilize and fix the spine. It is surgically implanted into the patient's body.
- Lack of Specimen Analysis: The provided text describes a mechanical device for surgical implantation and fixation. There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
Therefore, based on the provided information, the EBI® SpineLink™ - II Spinal Fixation System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EBI® SpineLink™ - II Spinal Fixation System is a spinal fixation device for pedicle screw fixation, and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine, and an anterior fixation system.
When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocations; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; scollosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection. The transverse connector is not intended for anterior fixation.
Product codes (comma separated list FDA assigned to the subject device)
KWP, KWQ, MNI, MNH
Device Description
The EBI® SpineLink™ II Spinal Fixation System is a spinal fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, non-cervical spine, thoracic, lumbar, sacral spine, fifth lumbar -- first sacral (L5 -- S1) vertebral joint, L3 and below, sacrum, ilium, anterolateral vertebral bodies of the lumbar and thoracic spine.
Indicated Patient Age Range
Skeletally mature patients
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 comparing the System to two predicate systems demonstrates that the device complies with applicable standards and meets all of its functional requirements.
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.
EBI® SpineLink™ System, EBI® Omega 21™ System, Webb-Morley Spine System
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
Koi2516
NOV 2 7 2001
510(k) Summary
This 510(k) Summary for the EBI® SpineLink™ - II Spinal Fixation System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
| 1. Submitter: | EBI, L.P. | Contact Person: Patricia Flood, RAC |
|---|---|---|
| 100 Interpace Parkway | Telephone: (973) 299-9300, ext.3318 | |
| Parsippany, NJ 07054 |
August 3, 2001 Date prepared:
| 2. Proprietary Name: | EBI® SpineLink™ - II Spinal Fixation System |
|---|---|
| Common Name: | Spinal Fixation Device |
| Classification Names: | Spinal Intervertebral Body Fixation Orthosis |
3. Predicate or legally marketed devices that are substantially equivalent:
- EBI® SpineLink™ System .
- EBI® Omega 21™ System .
- Webb-Morley Spine System .
-
- Description of the device: The EBI® SpineLink™ II Spinal Fixation System is a spinal fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties.
-
- Intended Use: The EBI® SpineLink™ II Spinal Fixation System is a spinal fixation device for pedicle screw fixation, and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine, and an anterior fixation system.
1
When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocations; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar -- first sacral (L5 -- S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection. The transverse connector is not intended for anterior fixation.
-
- Materials: The components of the System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136.
2
7. Comparison of the technological characteristics of the device to predicate
devices: There are no significant differences between the EBI® SpineLink™ - II Spinal Fixation System and other legally marketed spinal systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials, and function. Mechanical testing comparing the System to two predicate systems demonstrates that the device complies with applicable standards and meets all of its functional requirements.
*Any statement made in conjunction with this submission of substantial oguisented without pre-market anyonal * Any statement made in conjunction with this submitted without without pre-market approval or other product is intended only to relate to whicher the product of any other type of evidence in patent reclassification and is not mended to oc interpreted as an Premiser Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird with three distinct head profiles, suggesting a sense of unity or collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 7 2001
Ms. Patricia Flood, RAC Senior Regulatory Affairs Specialist EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054
K012516/S1 Re:
EBI@ SpineLink™-II Spinal Fixation System Regulation Numbers: 888.3050, 888.3060, and 888.3070 Regulation Names: Spinal Interlaminal Fixation Orthosis; Spinal Intervertebral Body Fixation Orthosis; and Pedicle Screw Spinal System Regulatory Class: II Product Codes: KWP; KWQ; MNI; and MNH Dated: October 31, 2001 Received: November 5, 2001
Dear Ms. Flood:
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Patricia Flood, RAC
This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begit marketing your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantial equivaled of 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 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for in vitto dagustic as on the promotion and advertising of your device, (301) 594-4659. Additionally, for questions on the program. Also, please note the regulation please contact the Office of Complanet at (301) - 1 1037 - 1 1037 - 121 - 121 - 121 - 121 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 12 entitled, "Misbranding by enereice op plemanse the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained its toll information on your responsibilities under Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-freezesmann h Manufacturers, International and Colisumer Assistance at it Note (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsma/dsmamain.html.
Sincerely yours,
Sincerely yours,
Mark N Milburn
Celia M. Witten, Ph.D., M.D. Director
Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K012516
Device Name: EBI® SpineLink™ - II Spinal Fixation System
Indications For Use:
The EBI® SpineLink™ - II Spinal Fixation System is a spinal fixation device for pedicle screw fixation, and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine, and an anterior fixation system.
When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocations; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; scollosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection. The transverse connector is not intended for anterior fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CFR 801.109) | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | -------------------------------------------------- |
|---|
for Mark H. Millman
| (Division Sign-Off) |
|---|
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K012576 |
|---|---|
| --------------- | --------- |