(244 days)
Not Found
No
The summary describes a physical spinal implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an implant used to replace a vertebral body due to tumor or trauma/fracture. This function directly treats or alleviates a physical condition, classifying it as therapeutic.
No
The device is an implantable vertebral body replacement, not a diagnostic tool. Its purpose is to replace resected or excised vertebral bodies due to tumor or trauma/fracture, not to diagnose a condition.
No
The device description clearly states it is a "Spinal implant," which is a physical hardware device intended for surgical implantation. The summary does not mention any software component that constitutes the primary medical device.
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.
- MOBIS® Spinal Implant Function: The MOBIS® Spinal Implant is a physical implant designed to replace a vertebral body in the spine. It is surgically implanted into the body.
- Intended Use: The intended use clearly states it's for replacing a resected or excised vertebral body due to tumor or trauma/fracture. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description of the device and its intended use clearly indicate it is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The MOBIS® Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.
The MOBIS® may be implanted singularly or in pairs.
The supplemental internal fixation systems that may be used with the MOBIS® includes, but is not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile.)
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The MOBIS® Spinal implant is the same as the predicate device except that it is supplied with either Titanium or Tantalum marker pins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (from 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): 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
DEC 1 8 2006
510(k) Summary
| Submitter: | SIGNUS Medizintechnik GMBH
Carl-Zeiss-Str. 2
Alzennau, Germany D-63755 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy L. Gray, RN, BS RAC
Principal Consultant
Alquest, Inc.
Phone: (763) 588-9873 Fax: (763) 287-3836 |
| Date Prepared: | 12/12/06 |
| Trade Name: | MOBIS® |
| Classification Name and Number: | 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device | Curved PEEK TETRIS™ cleared under K041888 on 8/10/24. |
| Device Description: | The MOBIS® Spinal implant is the same as the predicate device except
that it is supplied with either Titanium or Tantalum marker pins. |
| Intended Use: | The MOBIS® Spinal Implant has the same indication for use as the
predicate device. |
| Statement of Technological Comparison | The subject device have the following similarities:
The same indication for use; The same operating principle; The same basic design; The same materials; Implanted using the same surgical techniques and equipment; Used in conjunction with the same types of supplemental internal fixation systems; The same manufacturing environment; The same sterilization process; and The same packaging configurations. In summary, the MOBIS®, as described in this submission is, in the opinion of SIGNUS GmbH, substantially equivalent to the predicate device. |
| Conclusion: | The MOBIS® as modified in this submission is substantially equivalent to the predicate device, the Curved PEEK TETRIS™, cleared under K041888. This conclusion is based upon the similarities of the devices in terms of functional design, indication for use, principles of operation. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SIGNUS Medizintechnik GMBH c/o Ms. Tracy Gray Alquest Medical 6713 Lakeway Drive Chanhassen, Minnesota 55317
DEC I 8 2006
Re: K061082
Trade Name: MOBIS® Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: November 17, 2006 Received: November 21, 2006
Dear Ms. Grey:
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 -- Ms. Tracy Gray
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buend
Mark N. Melkerson, M.S. 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:
Device Name:
MOBIS® Spinal Implant
Indications For Use:
The MOBIS® Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.
The MOBIS® may be implanted singularly or in pairs.
The supplemental internal fixation systems that may be used with the MOBIS® includes, but is not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile.)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Varbare Bneup
(Division Sign-( M) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K061082