(264 days)
The Denali Deformity 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 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 Deformity 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); turnor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.
The Denali Deformity System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking set screws, offset connectors and transverse connectors. All of the 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 or sacral spine.
The Denali Deformity System received 510(k) clearance based on substantial equivalence to predicate devices, rather than meeting specific performance criteria through a clinical study. The provided documentation focuses on biomechanical testing against existing devices and a comparison of design features and materials.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this 510(k) submission was substantial equivalence to predicate devices. This means the device's performance, indications for use, and technological characteristics were compared to existing, legally marketed devices.
| Acceptance Criteria (Proxy) | Reported Device Performance |
|---|---|
| Substantial Equivalence: Device must perform equally to or better than predicate systems in biomechanical testing. | "The Denali Deformity System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717." |
| Similarity in Design, Function, Material, and Intended Use: Must be substantially the same as predicate devices. | "The design features and sizing of the components were also compared and the Denali Deformity System found to be substantially the same as these systems. It is manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems." |
| No Significant Adverse Differences: Must not have significant differences that would adversely affect product use compared to predicate devices. | "There are no significant differences between the Denali Deformity Spinal System and other systems currently being marketed which would adversely affect the use of the product." |
2. Sample Size for the Test Set and Data Provenance
The provided document does not describe a clinical test set of patients or data in the way a diagnostic AI device would. The "test set" here refers to the biomechanical testing performed on the device itself.
- Sample Size for Test Set: Not specified in terms of number of device units, but refers to "biomechanical testing" and "ASTM testing to F1717." This likely involves multiple iterations and samples of the device components.
- Data Provenance: The testing was done on the manufactured device components. The document doesn't specify a country of origin for the data beyond implying it was part of the K2M, LLC development process. It is not retrospective or prospective patient data.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the clearance was based on substantial equivalence and biomechanical testing, not on comparison to expert-established ground truth from patient data. There were no human experts establishing ground truth for a clinical test set in this context.
4. Adjudication Method for the Test Set
This is not applicable as there was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted or referenced. This type of study is relevant for evaluating the impact of an AI device on human reader performance, which is not the basis for clearance of a spinal implant system.
6. Standalone Performance Study
A standalone (algorithm-only) performance study was not conducted or referenced in the context of an AI device. The "standalone performance" for this device would be its mechanical performance as measured by ASTM standards.
7. Type of Ground Truth Used
The "ground truth" for this submission was based on established engineering standards (ASTM F1717) for spinal implant testing and comparison to the characteristics of predicate devices that have already been deemed safe and effective.
8. Sample Size for the Training Set
This information is not applicable. Medical device clearances based on substantial equivalence and biomechanical testing do not involve "training sets" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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K052404
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510(k) Summary for the Denali Deformity System
This safety and effectiveness summary for the Deformity 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 F1 Leesburg, VA 20175
Date Prepared: August 29, 2005 Contact Person : Richard W. Woods K2M, LLC 751 Miller Drive, SE, Suite F1 MAY 2 3 2006 Leesburg, VA 20175 Telephone: 703-777-3155
MAY 23 2006
| 2. Tradename: | Denali Deformity 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 ) ●
- Denali Spine System ( K2M, LLC ) .
- CD Horizon Legacy 5.5mm Spinal System (Medtronic Sofamor Danek) .
4. Description of the device:
The Denali Deformity System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking set screws, offset connectors and transverse connectors. All of the 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 or sacral spine.
5. Intended Use:
The Denali Deformity 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 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 Deformity 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; tumor, pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to 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 :
The Denali Deformity System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717. The design features and sizing of the components were also compared and the Denali Deformity System found to be substantially the same as these 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 Deformity Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2006
K2M, L.L.C. c/o Mr. Richard W. Woods Senior Vice President 751 Miller Dr., SE, Suite F-1 Leesburg, Virginia 20175
Re: K052404
Trade/Device Name: Denali Deformity System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: April 24, 2006 Received: April 26, 2006
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. Ilsting 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.
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Page 2 - Mr. Richard W. Woods
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" (21 CFR 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/industry/support/index.html.
Sincerely yours,
Herbert Lenner us
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health h
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Denali Deformity System
Indications for Use:
The Denali Deformity 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 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 Deformity 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); turnor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after 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)
Hubert Lerner us
Division of General, Restorative, and Neurological Devices
510(k) Number K052464
§ 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.