SPINAL CONCEPTS INC. CADENCE AND TRAXIS by SPINAL CONCEPTS, INC.

Cadence and TraXis are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Device Description

Cadence™ is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polvaryletheretherketone, ASTM F2026) and is offered in a tapered style of various sizes.

TraXisTM is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polyaryletheretherketone, ASTM F2026) and is offered in various lengths, widths and heights.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Spinal Concepts, Inc. Cadence™ and TraXis™ vertebral body replacement devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study with acceptance criteria and a detailed study report. Therefore, many of the requested elements (like specific numerical acceptance criteria, sample sizes for test/training sets, expert qualifications, and MRMC studies) are not present in this document.

However, I can extract the relevant information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Requirements	Mechanical testing demonstrated that Cadence™ and TraXis™ exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine.
Material Equivalence	Crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polyaryletheretherketone, ASTM F2026). Predicate device (titanium version of Cadence, K031914) was also titanium.
Design Equivalence	Hollow device with texture on two opposing flat sides. Offered in tapered style (Cadence) or various lengths, widths, and heights (TraXis). Similar to predicate device.
Intended Use Equivalence	Vertebral body replacement in thoracic and/or thoracolumbar spine (T3 - L5) due to tumor or trauma (fracture), to restore biomechanical integrity with bone graft. This matches the predicate device's intended use.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not specified in the document. The mechanical testing mentioned would have involved a sample size of devices, but this detail is not provided.
Data Provenance: Not specified. The document states "Mechanical Testing," implying a laboratory study, but does not give details on the location or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/Not mentioned. The "study" mentioned is "Mechanical Testing," which evaluates the physical characteristics of the device, not a diagnostic or prognostic performance requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. Mechanical testing typically involves objective measurements, not adjudication of interpretations.

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

No, a MRMC comparative effectiveness study was not done. The document describes mechanical testing of a medical device, not a study involving human readers and AI for clinical interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device, not an algorithm. The "mechanical testing" could be considered a form of standalone performance evaluation for the device itself.

7. Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be the engineering specifications and biomechanical requirements for a vertebral body replacement device, against which the device's performance (e.g., strength, durability under load) is measured. It is not an expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. See point 8.

Summary

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510(K) Summary

K033517
Page 1 of 1

Submitted By:

Lisa Peterson Regulatory Affairs Specialist Spinal Concepts, Inc. 5301 Riata Park Court, Bldg. F Austin, TX 78727 512-918-2700

November 6, 2003

Trade Name:	Spinal Concepts Inc. CadenceTM and TraXisTM
Classification Name:	Vertebral Body Replacement
Product Code:	MQP

Predicate Device: Cadence™ (PEEK version) and TraXis™ are substantially equivalent to the titanium version of Cadence, cleared via K031914.

Device Description: Cadence™ is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) or PEEK OPTIMATM (polvaryletheretherketone, ASTM F2026) and is offered in a tapered style of various sizes.

Intended Use: Cadence and TraXis are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.

Mechanical Testing: Mechanical testing demonstrated that Cadence™ and TraXisTM exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2004

Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts, Inc. 5301 Riata Park Court, Bldg. F Austin, Texas 78727

Re: K033517 Trade/Device Name: Spinal Concepts, Inc. Cadence™ and TraXis™ Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 28, 2004 Received: January 29, 2004

Dear Ms. Peterson:

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 Codc 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 ITDA'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 - Ms. Lisa Peterson

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely vours.

Mark A. Milliman

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 STATEMENT

Page 1 of 1

510(k) Number (if known): K0335 17

Device Name:

Spinal Concepts, Inc. Cadence™ and TraXisTM

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:	X OR Over-The-Counter:
(Per 21 CFR 801.109)	(Optional Format 1-2-96)

Mah n Milken

K033577

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number	K033577
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Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.