(55 days)
K2M Denali Spinal System
No
The summary describes a physical implant (a hollow tube structure made of PEEK) used for vertebral body replacement. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is intended for partial replacement of a diseased vertebral body and to restore the height of a collapsed vertebral body, which are therapeutic functions.
No
The Aleutian Spacer System is described as a vertebral body replacement device used to restore the integrity of the spinal column and provide stabilization. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a hollow tube structure manufactured from Medical Grade PEEK and Tantalum beads, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Aleutian Spacer System Function: The description clearly states the Aleutian Spacer System is a "vertebral body replacement device" and a "hollow tube structure manufactured from Medical Grade PEEK". It is surgically implanted into the thoracolumbar spine to replace a diseased vertebral body and restore spinal height and integrity. This is an implantable medical device used within the body (in vivo).
The intended use, device description, and function all point to a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Aleutian Spacer System is indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian Spacer System is designed to restore the integrity of the spinal column even in the absence of fusion for a prolonged period.
The Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental internal fixation intended to be used with this implant is the K2M Denali Spinal System.
Product codes
MQP
Device Description
The Aleutian Spacer System consists of a hollow tube structure manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match varying patient anatomies and which are designed to engage with the vertebral body end plates.
Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone): OPTIMA I T1 (Invibio) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads to be Grade UNS R05200 according to ASTM F560.
Function: The system functions as a vertebral body replacement device to assist in fusion and to provide stabilization of the thoraco-lumbar segments of the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043405, K042930, K043316, K003709
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 27 2005
510(k) Summary of Safety and Effectiveness for the Aleutian Spacer System
This safety and effectiveness summary for the Aleutian Spacer System is provided as required per Section 513(()(3) of the Food, Drug and Cosmetic Act.
- Submitter :
K2M. LLC 751 Miller Drive SE, Suite F1 Leesburg, VA 20175
May 24, 2005 Date Prepared:
Contact Person : Richard W. Woods K2M, LLC 751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: 703-777-3155
| 2. Tradename: | Aleutian Spacer System |
|---|---|
| Common Name: | Vertebral Body Replacement Device |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis ( 888.3060 ) |
3. Predicate or legally marketed devices which are substantially equivalent :
- NuVasive, Inc. CoRoent system (K043405) .
- SpineVision, Inc. Spacevision™ Cage system (K042930) .
- Signus Medizintechnik GMBH Rabea™ (K043316) .
- Surgical Dynamics™ Mesh Cage System (K003709) .
4. Description of the device:
The Aleutian Spacer System consists of a hollow tube structure manufactured from Medical Grade PEEK The Aleutian Spacel System Collists of a nonor tabe samety of different sizes and heights to match more (Polyetherethersetone). The crevices are avanable in a varies of answer and which are designed to engage with the vertebral body end plates.
Materials: The devices are manufactured from Medical Grade PEEK (Polyetherether): OPTIMA I T1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads to be Grade UNS R05200 according to ASTM F560.
Function: The system functions a vertebral body replacement device to assist in fusion and to provide I he System railoneration of the thoraco-lumbar segments of the spine.
5. Intended Use:
The Aleutian Spacer System is indicated for use in the thoracolumbar spine (T1 to L5) for partial I he Aleutan Spacer System is manufact to adiseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord neural of fumors of traumarracture in ofter to acmore and body. The Aleutian Spacer System is designed to tissues, and to resore the neight of a conapoed verteerar spinal column even in the absence of fusion for a prolonged period.
The Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental The Arculan Spacer Dystem is invith this implant is the K2M Denali Spinal System.
-
- Comparison of the technological characteristics of the device to predicate and legally marketd devices corrently bein arrison of the technological characterishes of the active and other systems and other systems other I here are no significant differences between the Fitchan opposes by and the substantially equivalent to these other devices in design, function, material and intended use.
11
- Comparison of the technological characteristics of the device to predicate and legally marketd devices corrently bein arrison of the technological characterishes of the active and other systems and other systems other I here are no significant differences between the Fitchan opposes by and the substantially equivalent to these other devices in design, function, material and intended use.
1
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 eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
JUL 27 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard W. Woods Senior Vice President K2M, LLC 751 Miller Drive SE, Suite F-1 Leesburg, Virginia 20175
Re: K051454
Trade/Device Name: Aleutian Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 20, 2005 Received: July 21, 2005
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 If your de rise 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 or any I 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 - 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 premainer noticate 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" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other goteral miserminational 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,
Stipt Rhodes
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) : K051454
Device Name: Aleutian Spacer System
Indications-For-Use:
The Aleutian Spacer System is indicated for use in the thoracolumbar spine (T1 to L5) The Aleunan Spacer System is indicated for associeered vertebral body, resected for partial replacement (f.e., partial verteored to restore in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a decompression of the Spilar Cord and noular trasses, eson is designed to restore the collapsed vehebral body. "The Trioutian Bpaces by carrior spinsal column even in the absence of fusion for a prolonged period.
The Aleutian Spacer System is intended to be used with supplemental internal fixation. The Aleutan Spacer System is intended to be used with this implant is the K2M Denali Spinal System.
Prescription use X ( Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter use (21 CFR 807 Subpart C)
Stup Rurds
HS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED } e of Device Evaluation ( ODE ) Division of Gen
Neurological Devices
İV
510(k) Number K051454