(114 days)
Not Found
No
The summary describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a supplemental fixation device intended to aid in fusion; it does not actively treat or cure a disease but rather provides support.
No
The provided text describes a medical implant (Spineology Spinous Process Plate) used for supplemental fixation in the non-cervical spine, intended for surgical treatment of various conditions. It is a therapy device, not a diagnostic one.
No
The device description explicitly states it is a "three-part titanium device" and describes physical testing (static and dynamic) of the device, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Spineology Spinous Process Plate is a physical implant designed to be surgically placed in the spine for fixation and fusion. It does not interact with or analyze biological samples.
- Intended Use: The intended use describes a surgical procedure and the conditions it is used to treat, not the analysis of biological specimens.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Spineology Spinous Process Plate is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1 - S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions:
• Degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• Trauma (i.e., fracture or dislocation)
• Spondylolisthesis
• Tumor
The Spineology Spinous Process Plate is not intended for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Spineology Spinous Process Plate is a non-pedicle fixation device that clamps bilaterally to the spinous processes. The three-part titanium device is provided sterile and not intended for stand-alone use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1 - S1)
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)
Static (compression and torsion) and dynamic (compression and torsion) testing was performed per ASTM F1717. Static dissociation testing and push-out from foam (plate grip strength) was also completed.
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.
K032037, K043053, K102886, K103091
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
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K123232
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FEB 7 2013
| Appendix C | 510(k) Summary |
|---|---|
| Applicant: | Spineology Inc. |
| 7800 3rd Street N., Suite 600 | |
| Saint Paul, MN 55128 | |
| 651-256-8500 | |
| Contact Person: | Bryan Becker |
| Date Prepared: | October 15, 2012 |
| Trade Name: | Spineology Spinous Process Plate |
| Reason for This | |
| 510(k): | New device |
| Product | |
| Classification and | |
| Code: | Class II Medical Device, Product Code KWP, 21 CFR 888.3050, Spinal |
| Interlaminal Fixation Orthosis | |
| Predicate Device(s): | CD HORIZON SPIRE™, Medtronic Sofamor Danek (K032037, |
| K043053, and K102886) and Lanx Aspen, Lanx (K103091) | |
| Device Description: | The Spineology Spinous Process Plate is a non-pedicle fixation device |
| that clamps bilaterally to the spinous processes. The three-part titanium | |
| device is provided sterile and not intended for stand-alone use. | |
| Intended Use: | The Spineology Spinous Process Plate is a posterior, non-pedicle |
| supplemental fixation device, intended for single level use in the non- | |
| cervical spine (T1 - S1). It is intended for single level plate | |
| fixation/attachment to spinous process for the purpose of achieving | |
| supplemental fusion in the following conditions: | |
| • Degenerative disc disease - defined as back pain of discogenic | |
| origin with degeneration of the disc confirmed by history and | |
| radiographic studies. | |
| • Trauma (i.e., fracture or dislocation) | |
| • Spondylolisthesis | |
| • Tumor | |
| The Spineology Spinous Process Plate is not intended for stand-alone use. | |
| Summary of | |
| Technological | |
| Characteristics: | The device is shown to be substantially equivalent to the intended use, |
| materials, configuration, and performance characteristics of the predicate | |
| products. | |
| Testing: | Static (compression and torsion) and dynamic (compression and torsion) |
| testing was performed per ASTM F1717. Static dissociation testing and | |
| push-out from foam (plate grip strength) was also completed. | |
| Conclusion: | The information submitted in this premarket notification supports a |
| determination that the Spineology Spinous Process Plate is substantially | |
| equivalent in technological characteristics and intended use to the | |
| predicate device. |
.
ﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨﻨ ":"
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: February 7, 2013
Spineology Incorporated % Mr. Bryan Becker Regulatory Affairs Manager 7800 310 Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K123232
Trade/Device Name: Spineology Spinous Process Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: January 4, 2013 Received: January 8, 2013
Dear Mr. Becker:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Mr. Bryan Becker
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Appendix D Indications for Use Form
510(k) Number(if known): K123232
· Device Name: The Spineology Spinous Process Plate
Indications for Use:
The Spineology Spinous Process Plate is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1 - S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions:
- · Degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- · Trauma (i.e., fracture or dislocation)
- Spondylolisthesis
- · Tumor
The Spineology Spinous Process Plate is not intended for stand-alone use.
| Prescription Use X | বে বিশ্বকাপের প্রকল্পে করে বিশ্বকাপে বিশ্বকাপ বিশ্বকাপ থেকে বিশ্বকাপ করে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে। এরপর পর পর পর পর কর | AND/OR |
|---|---|---|
| (Part 21 CFR 801 Subpart D) |
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)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123232
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