(105 days)
Xia Spine System ( Stryker Howmedica Osteonics ), Global Spine Fixation System ( U & I Corporation ), CD Horizon Spinal System ( Medtronic Sofamor Danek )
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies focus on biomechanical testing and comparison to predicate devices, not algorithmic performance.
Yes
The Denali Spinal System is intended for various spinal conditions like degenerative disc disease, spondylolisthesis, trauma, and spinal stenosis, and functions as an adjunct to fusion for immobilization of spinal segments. These indications and functions align with the definition of a therapeutic device.
No
Explanation: The Denali Spinal System is a spinal fixation device intended for stabilization and immobilization of the spine, functioning as an adjunct to fusion. It does not perform any diagnostic function such as identifying or diagnosing a condition.
No
The device description clearly states it is a "multiple component, posterior system" manufactured from Ti6Al-4V ELI alloy, indicating it is a physical implant and not software.
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 for spinal fixation and fusion, which are surgical procedures performed directly on the patient's body.
- Device Description: The description details a system of components made from Ti6Al-4V ELI alloy designed to provide immobilization of spinal segments. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to be implanted within the body for structural support or fixation.
N/A
Intended Use / Indications for Use
The Denali Spinal System is a non-cervical spinal fixation device intended for posterior, non-pedicicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Denali Spinal System is also intended for non-cervical pedicle screw fixation for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) at L5-S1 in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and/ or sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNH, MNI
Device Description
The Denali Spine System is a top-loading, multiple component, posterior system which consists of a variety of rods, longitudinal соединители, hooks, screws, and cross connectors. All components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal, thoracic, lumbar and / or sacral spine, L5-S1, L3 to sacrum
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)
The Denali Spine System was biomechanically tested and compared to the Xia Spine System. The design features and sizing of the Denali System were found to be substantially the same as the predicate systems. It is manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems. There are no significant differences between the Denali Spinal System and other systems currently being marketed which would affect the safety and effectiveness as the Denali System is equivalent to these other devices in design, function, material and intended use.
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.
Xia Spine System ( Stryker Howmedica Osteonics ), Global Spine Fixation System ( U & I Corporation ), CD Horizon Spinal System ( Medtronic Sofamor Danek )
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
JAN 1 0 2005
K042635
Page 1 of 1
510(k) Summary
for the
Denali Spinal System
This safety and effectiveness summary for the Denall Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
1. Submitter :
K2M, LLC 751 Miller Drive SE, Suite F 1 Leesburg, VA 20175 Contact Person : Richard W. Woods K2M. LLC 751 Miller Drive SE, Suite Fl Leesburg, VA 20175 Telephone: 703-777-3155
September 24, 2004 Date Prepared:
| 2. Tradename: | Denali Spinal System |
|---|---|
| Common Name: | Spine Fixation System |
| Classification Name: | Pedicle Screw Spinal System (21 CFR 888.3070(b)(1) ) |
| Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050 ) |
3. Predicate or legally marketed devices which are substantially equivalent :
- Xia Spine System ( Stryker Howmedica Osteonics ) .
- Global Spine Fixation System ( U & I Corporation ) .
- CD Horizon Spinal System ( Medtronic Sofamor Danek ) .
4. Description of the device :
The Denali Spine System is a top-loading, multiple component, posterior system which consists of periety of periety I he Dellar Spite Systems a top-loading, matchers components are available in a variety of sizes to match more closely the patient's anatomy.
Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.
5. Intended Use:
The Denali Spinal System is a non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the following natually instered in the United ( DD A (deliver of the may i i.e. fracture or dislocation ); spinal stenosis; uise commitical by instol y and for lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Denali Spinal System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation in enres ( i.e. scoliosis, kyphosis, kyphosis, and/or locals on de land indications: natination of dision. It is also indicated for the treatment of severe spondylolishes it grades 3 and 4 h pseudoultifies and idited previous resistents receiving fusion by autogenous bone graft having implants attached to the or the 25-51 verteord in steleo sacrum ) with removal of the implants after the attainment of a solid fusion.
6. Comparison of the technological characteristics of the device to predicate and legally marketed
devices :
S :
The Denali Spine System was biomechanically tested and company of 117.77 The design for the present and sizing for the The Denall System was blomethanding tested and compare of 1717. The design features and sizing of the systems and performed oqual to be other Denali System found to be substantially the same as these systems. It is components were also compared and the Denail by indicated for the same intended uses as these systems. manufactured from the same I DA recognized materials and is national other systems currently being marketed which I here are no significant unfectives between the Delian Byouwalent to these other devices in design, function, material and intended use.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2005
Mr. Richard W. Woods Senior Vice President K2M. LLC 751 Miler Drive SE, Suite F1 Lessburg, VA 20175
Re: K042635
Trade/Device Name: Denali Spine System Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; pedicle screw system Regulatory Class: Class II Product Code: KWP, MNH, MNI Dated: September 24, 2004 Received: September 28, 2004
Dear Mr. Woods:
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
2
Page 2 -- Mr. Richard W. Woods
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declions of Covice as described in your Section 510(k) I his letter will anow you to oegin marketing your avivalence of your device to a legally premarket nothleation. The PDA midning of backers. In 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 spectife davice ion your act (240) 276-0120. Also, please notes and office of "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain Misbranding by ICICICNC to promation in the Act from the Division of Small other gelleral information on your responsion.com 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,
Miriam C. Provost
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
3
Indications for Use
510(k) Number (if known): K042635
Device Name: Denali Spinal System
Indications for Use:
The Denali Spinal System is a non-cervical spinal fixation device intended for posterior, non-pedice fixation The Denali System is a non-cervical spillar installed (DDD) (defined as bath pain of discogenic origin for the following indications: degenerative discuse ( is studies ); spondylolisthesis; trauma ( i.e.
with degeneration of the disc confirmed by history and radiogas ); spond with degeneration of the disc committed by instory and radiographis of the scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Denali Spinal System is also intended for non-cervical pedicle screw fixation for the following The Denali System is also intelited to non-ec-rosis; curvatures ( i.e. scoliosis, syphosis; and/or
indications: trauma ( i.e. fracture or disiocation ); spinal sed for treat indications: trauma ( ... . fracture of uniocation ); spira fusion. It is also indicated for the treament of severe
lordosis); tumor; pseudoarthrosis; and failed previous fus lordosis); tumor; pseudoarthrosis; and falled province in skeletally mature natients receiving fusion by spondylolisthesis ( grades 5 and 4 ) 0 the L.5-1 v.the hil skerean) mana paral spine ( L3 to sacrum ) with removal
autogenous bone graft having implants attached to the lumba autogenous offer the attainment of a solid fusion.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS-LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042635