(103 days)
Not Found
No
The 510(k) summary describes a mechanical implant (vertebral body replacement) and its material properties and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a vertebral body replacement intended to restore the biomechanical integrity of the spine due to tumor or trauma, addressing a physiological issue.
No
The device is described as a vertebral body replacement device, which is a therapeutic implant, not a diagnostic tool. Its purpose is to restore biomechanical integrity after a vertebrectomy.
No
The device description explicitly states the devices are crafted from titanium alloy or PEEK, indicating they are physical implants, 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 states that Cadence and TraXis are "vertebral body replacement devices" used in surgical procedures to replace damaged or unstable vertebral bodies. This is a therapeutic and structural function within the body.
- Device Description: The description details the materials and physical characteristics of the implants, which are designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a structural implant.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MQP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or thoracolumbar spine (T3 - L5)
Indicated Patient Age Range
Not Found
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)
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.
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.
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
§ 888.3060 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.
0
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.
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.
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.
1
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.
2
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
3
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:
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.
(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
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K033577 |
|---|---|
| --------------- | --------------------------------------------------------- |