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 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 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.

Device Description

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.

AI/ML Overview

The provided 510(k) summary for the Denali Spinal System does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

This 510(k) submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo acceptance criteria and then proving the device meets them through a specific clinical study with granular details like sample size for test sets, expert qualifications, or MRMC studies.

Here's a breakdown of why the requested information cannot be extracted from the provided document:

Nature of 510(k) Submissions: 510(k)s are primarily premarket notifications to demonstrate that a new device is as safe and effective as (i.e., substantially equivalent to) a legally marketed predicate device. They typically rely on comparisons of technological characteristics, materials, and intended use, often supported by bench testing (biomechanical, material compatibility) rather than extensive clinical efficacy trials with acceptance criteria in the manner requested.

Information that could be inferred/stated from the document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied): The implied acceptance criterion for this 510(k) is "substantial equivalence" to the listed predicate devices in terms of design, function, materials, and intended use.

Reported Device Performance (Implied): The document states "The Denali System was biomechanically tested and compared to its predicate devices... The Denali System found to be substantially the same as these systems." and "It's components were manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems."

Acceptance Criterion (Implied for 510(k))	Reported Device Performance
Substantially equivalent in design	Found to be substantially the same as predicate devices.
Substantially equivalent in function	Performed equal to predicate devices.
Substantially equivalent in materials	Manufactured from the same FDA recognized materials.
Substantially equivalent in intended use	Indicated for the same intended uses as predicate systems.
Biomechanical performance	Biomechanically tested and compared favorably to predicate devices.

2. Sample sized used for the test set and the data provenance:

Not provided. The document mentions "biomechanically tested" but does not specify sample sizes for these tests, nor the data provenance (country, retrospective/prospective). This is typically detailed in engineering reports, not summarized in the 510(k) in this level of detail.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. For a 510(k) based on substantial equivalence and biomechanical testing, "ground truth" related to clinical outcomes or expert consensus on observations isn't typically established in this manner. The "truth" is based on established engineering principles and comparison to predicate devices.

4. Adjudication method for the test set:

Not applicable/Not provided. This is relevant for studies involving human interpretation or clinical endpoints, which is not the focus of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No. An MRMC study is not mentioned or implied. MRMC studies are specific to evaluating the diagnostic performance of imaging devices/algorithms with multiple human readers, often comparing performance with and without AI assistance. This device is a spinal implant, not an imaging device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This refers to AI algorithms for diagnosis or analysis. The Denali Spinal System is a physical medical device (implant), not an algorithm.

7. The type of ground truth used:

The "ground truth" for demonstrating substantial equivalence for this device would be:
- Engineering specifications and material standards: Adherence to ASTM and ISO standards for materials (Ti6Al-4V ELI alloy).
- Bench test results: Biomechanical performance data showing comparability to predicate devices.
- Functional comparison: Direct comparison of design features and sizing to predicate devices.

8. The sample size for the training set:

Not applicable/Not provided. There is no "training set" in the context of this 510(k) for a spinal implant. This term relates to machine learning models.

9. How the ground truth for the training set was established:

Not applicable/Not provided. As there's no training set, there's no ground truth establishment for it.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/software device. Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth establishment (especially those related to human readers, experts, and AI algorithms) are not present and are not typically required for this type of submission.

Summary

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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 :

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.

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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

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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

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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

Regulation Number and Section

§ 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.