The AXIS® Fixation System may be used from the C2 to T3 (inclusive) spinal levels for the following indications: (1) trauma, including spinal fractures and/or dislocations; (2) cervical instability or deformity; (3) pseudarthrosis or failed previous fusions; and (4) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; and/or degenerative disc disease of the facets with instability. Spinal screw fixation is to be achieved with posterior pedicle and/or lateral mass screws and plates implanted from C2 to T3 levels inclusively. Supplemental posterior fixation with the ATLASTM Cable must be used. The AXIS® Fixation System must be used with autograft or allograft.

Device Description

The AXIS® Fixation System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the lateral masses of the cervical spine using a posterior approach.

The AXIS® Fixation System implant components are made of titanium alloy. Titanium alloy and stainless steel implants should not be used together in a spinal construct. The AXIS® Fixation System components are supplied non-sterile.

AI/ML Overview

This document, K062254, is a 510(k) premarket notification for the AXIS® Fixation System. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics of the new device itself.

Based on the provided text, a formal study with acceptance criteria and reported device performance in the way a clinical trial might be presented is not available. The submission relies on "Substantial Equivalence" to other commercially available posterior cervical fixation systems and pre-enactment devices.

Here's an breakdown based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. 510(k) submissions for devices like this typically do not include a table of acceptance criteria and performance against those criteria in the same way a diagnostic algorithm's submission might. Instead, they demonstrate substantial equivalence through comparison of design, materials, indications for use, and, if applicable, mechanical testing data.

The document states:

"Literature, mechanical test reports and clinical data were supplied in support of establishing a claim of substantial equivalence."

However, the specifics of these mechanical test reports or clinical data, including their acceptance criteria and the device's performance against them, are not detailed in the provided summary.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. If "clinical data" was supplied for substantial equivalence, the details regarding sample size and data provenance are not included in this summary. Mechanical tests generally do not use "test sets" in the same way clinical studies do; they test physical samples of the device components.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. This concept is typically relevant for diagnostic device submissions where expert consensus establishes a "ground truth" for interpretation of medical images or data. For an orthopedic fixation system, ground truth would relate to clinical outcomes, which are not detailed here.

4. Adjudication Method

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in studies involving expert readers interpreting data, which is not the focus of this 510(k) summary for a surgical implant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and not provided. MRMC studies are typically used for diagnostic imaging devices to assess the impact of AI on human reader performance. This device is a surgical implant.

6. Standalone (Algorithm Only) Performance

This information is not applicable and not provided. This device is a physical surgical implant, not an algorithm.

7. Type of Ground Truth Used

This information is not provided in detail for any "clinical data" mentioned. For substantial equivalence of a surgical implant, "ground truth" would implicitly relate to the safety and effectiveness of the device as demonstrated by clinical outcomes, often compared to the predicate device's established safety and effectiveness. The document only vaguely mentions "clinical data" without detailing its nature or how outcomes were verified.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical surgical implant, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided. As above, this device is not an AI algorithm.

Summary of What is Present (Regarding "Study" and "Proof"):

The primary "proof" for the AXIS® Fixation System meeting requirements is its demonstration of Substantial Equivalence (SE) to legally marketed predicate devices. This is a regulatory pathway, not a detailed scientific study with specific acceptance criteria outlined in this summary.

The document states:

"Literature, mechanical test reports and clinical data were supplied in support of establishing a claim of substantial equivalence."

This implies that instead of conducting a de novo study with explicit acceptance criteria for this specific device, Medtronic Sofamor Danek provided evidence that:

The AXIS® Fixation System shares similar technological characteristics and indications for use with existing devices.
The mechanical properties of the device (likely through in vitro testing) are comparable to those of the predicate devices, ensuring it can withstand expected physiological loads.
Existing clinical data or literature broadly supports the safety and effectiveness of this type of device for the stated indications, thereby extrapolating that the comparable AXIS® system would also be safe and effective.

In conclusion, this 510(k) summary does not contain the detailed information requested regarding specific acceptance criteria and a structured study demonstrating the device's performance against those criteria. Its approval is based on the concept of substantial equivalence, supported by general categories of evidence (literature, mechanical tests, clinical data) rather than a singular, detailed performance study provided in this specific document.

Summary

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AXIS® Fixation System 510(k) Summary - K062254

JUN 1 6 2008

June 2008

I.	Company:	Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133
	Contact:	Lee Grant

Sr. Regulatory Affairs Specialist

Proposed Proprietary Trade Name: AXIS® Fixation System II.

Classification Name(s): Spinal Interlaminal Fixation Orthosis; Single/Multiple Component III. Metallic Bone Fixation Appliances and Accessories; Pedicle Screw Spinal System; Class: II, III (for degenerative disc disease) and/or unclassified; Product Code(s): KWP,HRS, MNI, NKB, NKG; and Regulation No.: 888.3050, 888.3030, and/or 888.3070
Description: The AXIS® Fixation System consists of a variety of shapes and sizes of bone IV. plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the lateral masses of the cervical spine using a posterior approach.

V. Indications for Use: The AXIS® Fixation System may be used from the C2 to T3 (inclusive) spinal levels for the following indications: { } ) trauma, including spinal fractures and/or dislocations: (2) cervical instability or deformity; (3) pseudarthrosis or failed previous fusions; and (4) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; and/or degenerative disc disease of the facets with instability. Spinal screw fixation is to be achieved with posterior pedicle and/or lateral mass screws and plates implanted from C2 to T3 levels inclusively. Supplemental posterior fixation with the ATLASTM Cable must be used. Refer to the ATLAS® Cable System package insert and surgical technique for further instructions. Additionally, the AXIS® Fixation System must be used with autograft or allograft.
Substantial Equivalence: The AXIS® Fixation System is substantially equivalent to other VI. commercially available posterior cervical fixation systems and other pre-enactment devices including the TOWNLEY® Transfacetpedicular Fixation System (K953076, SE 2/19/97 and K021705. SE 07/24/02). Literature, mechanical test reports and clinical data were supplied in support of establishing a claim of substantial equivalence.

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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and is on a white background. There is a logo to the left of the text.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek % Mr. Lee Grant Senior Project Specialist, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

JUN 1 6 2008

Re: K062254

Trade/Device Name: AXIS® Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system. Regulatory Class: III Product Code: NKB, NKG, MNI, HRS, KWP Dated: March 14 2008 Received: March 18, 2008

Dear Mr. Grant:

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. Iisting 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. Lee Grant

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Miller

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K062254

Device Name: AXIS® Fixation System

Indications for Use: The AXIS® Fixation System may be used from the C2 to T3 (inclusive) spinal levels for the following indications: (1) trauma, including spinal fractures and/or dislocations; (2) cervical instability or deformity; (3) pseudarthrosis or failed previous fusions; and (4) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; and/or degenerative disc disease of the facets with instability. Spinal screw fixation is to be achieved with posterior pedicle and/or lateral mass screws and plates implanted from C2 to T3 levels inclusively. Supplemental posterior fixation with the ATLASTM Cable must be used. The AXIS® Fixation System must be used with autograft or allograft.

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)

Mark A. Mellem

Division Sign-O Division of General, Restorative, and Neurological Devices

K062254

510(k) Number_

pay I
f I

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.