(106 days)
Not Found
No
The document describes a physical implant (a spinal spacer) and its materials and function, with no mention of software, algorithms, or data processing that would typically involve AI/ML.
Yes
The device is described as a "partial vertebral body replacement device to assist in fusion and to provide support and stabilization." This function, intended to restore biomechanical integrity and decompress the spinal cord by replacing diseased or fractured vertebral bodies, clearly indicates a therapeutic purpose.
No
The device is a partial vertebral body replacement system, designed to restore height and integrity to the spinal column after tumor or trauma, and to assist in fusion. It mechanically supports the spine rather than diagnosing conditions.
No
The device description clearly states the device is a "hollow tube structure manufactured from Medical Grade PEEK" and includes details about materials and physical function, indicating it is a physical implant, not software.
Based on the provided information, the Aleutian Spacer System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Aleutian Spacer System Function: The description clearly states that the Aleutian Spacer System is a surgical implant used to replace a portion of a vertebral body in the spine. It is a physical device implanted into the body to provide structural support and stability.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information about a patient's health status. Its function is purely mechanical and structural.
Therefore, the Aleutian Spacer System falls under the category of a medical device, specifically a surgical implant, rather than an in vitro diagnostic device.
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 biomechanical integrity of the anterior, middle, and posterior 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 fixation systems that may be used with this implant are the Denali System, Denali Deformity and Mesa Spinal system.
Product codes (comma separated list FDA assigned to the subject device)
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 ond heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are desired to angage with the vertebral body end plates.
Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560.
Function: The system functions as a partial vertebral body replacement device to assist in fusion and to provide support and 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
K063399
FEB 23 2007
510(k) Summary Aleutian Spacer System K2M, Inc.
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. Inc. 751 Miller Drive SE Suite F I Leesburg, VA 20175 Contact Person : Richard W. Woods K2M, Inc. 751 Miller Drive SE. Suite F1 Leesburg, VA 20175 Telephone: 703-777-3155
Date Prepared: November 6, 2006
- Tradename: Aleutian Spacer System Common Name: Vertebral Body Replacement Device Classification Name: Spinal Intervertebral Body Fixation Orthosis ( 888.3060 ) Product Code: MOP
3. Description of the device:
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 ond heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are desired to angage with the vertebral body end plates.
Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560.
Function: The system functions as a partial vertebral body replacement device to assist in fusion and to provide support and stabilization of the thoraco-lumbar segments of the spine.
4. Intended 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 of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord on and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even is the anserve of fusion for a prolonged period.
The Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental fixation systems that may be used with this implant are the Denali System, Denali Deformity and Mesa Spinal system.
5. Predicate or legally marketed devices which are substantially equivalent:
Documentation was provided which demonstrated that the subject Aleutian Spacer System components are substantially equivalent to the components previously cleared in the Aleutian Spacer System of IQ(k) K051454 (SE 07/27/2005).
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
There are no significant differences between the Aleutian Spacer System and other systems currently being marketed which would adversely affect the use of the product. It is 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 & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K2M, Inc. % Mr. Richard W. Woods 751 Miller Drive, SE - Suite F1 Leesburg, Virginia 20175
FEB 2 3 2007
Re: K063399
Trade/Device Name: Aleutian Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 23, 2007 Received: January 26, 2007
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 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 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 (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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehum
Mark N. Melkerson Director Division of General, Restorative, and Neurologic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k): K063399
Device Name : Aleutian Spacer System
K063399 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 biomechanical integrity of the anterior, middle, and posterior 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 fixation system that may be used with this implant is the Denali Spinal System, Denali Deformity and Mesa Spinal system.
| Prescription use | X |
|---|---|
| OR | Over-the-counter use |
| ( PER 21 CFR 801.109) | |
| Te. | |
| Di |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation ( ODE )
Obalare Bucheno
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K063399