(160 days)
Not Found
No
The 510(k) summary describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are focused on mechanical properties.
Yes
The device is intended for supplemental fusion in conditions such as degenerative disc disease, trauma, spondylolisthesis, and/or tumor, aiming to treat or alleviate these medical conditions.
No
The device is a posterior, non-pedicle supplemental fixation device intended for achieving fusion in the non-cervical spine, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components made of titanium alloy and nitinol, indicating it is a hardware device, not software-only.
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 the device is a "posterior, non-pedicle supplemental fixation device" for use in the spine to achieve "supplemental fusion." This describes a surgical implant used to stabilize the spine, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details the physical components of the device (plates, spikes, barrel, materials) and how they are used to fixate the spinous processes. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition. The device's function is purely mechanical fixation.
- Performance Studies: The performance studies listed are mechanical tests (compression, torsion, pullout, etc.) relevant to the structural integrity and function of a surgical implant, not analytical or clinical performance studies typical for IVDs.
In summary, the Spinal Elements' Spinous Process Plate System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Spinal Elements' Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. 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 radies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. Spinal Elements' Spinous Process Plate System is not intended for stand-alone use.
Product codes (comma separated list FDA assigned to the subject device)
PEK
Device Description
Spinal Elements' Spinous Process Plate System is comprised of a static plate and a translating plate for posterior fixation of the spine in order to achieve fusion. The plates are available in multiple sizes to accommodate various patient anatomies. Both the static plate and the translating plate present spikes to interface with the bone of the spinous processes. The barrel of the static plate passes through the insert of the translating plate such that, in their final position, the plates surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes. The spinous process plates are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 with a nitinol spring conforming to ASTM F2063 and a coating of commercially pure titanium conforming to ASTM F1580. Additionally, the plates feature a titanium coating on their medial surfaces as well as the initial portion of the barrel.
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
skeletally mature patients
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)
No clinical testing was found to be necessary. Non-clinical performance testing included:
- Static Compression and Torsion testing per ASTM F 1717
- Dynamic Compression Testing per ASTM F 1717
- Plate Dissociation per ASTM F1798
- Pullout Testing
- Particulate Analysis per ASTM F1877
- Corrosion testing per ASTM F2129
- Austenitic finish (Af) functional testing
All data indicates that the device will perform as intended.
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.
K151863 Reli SP Spinous Plating System (PRIMARY), K123246 CD HORIZON SPIRE, K100354 PrimaLOK sp Interspinous Fusion System
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.
0
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and merging into a single, flowing form.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2016
Spinal Elements, Incorporated Julie Lamothe, Ph.D., MBA Regulatory Affairs and Ouality Assurance Director 3115 Melrose Drive, Suite 200 Carlsbad, California 92010
Re: K160465
Trade/Device Name: Spinal Elements' Spinous Process Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: June 20, 2016 Received: June 22, 2016
Dear Dr. Lamothe:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Vincent J. Devlin -S
for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160465
Device Name
Spinal Elements' Spinous Process Plate System
Indications for Use (Describe)
Spinal Elements' Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. 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 radies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. Spinal Elements' Spinous Process Plate System is not intended for stand-alone use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Spinal Elements' Spinous Process Plate System
510(k) Number K160465
| Manufacturer Identification
Submitted by: | Spinal Elements Inc.
3115 Melrose Dr., Suite 200
Carlsbad, CA 92010
760-607-0121 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Julie Lamothe, Ph.D., MBA
Regulatory Affairs and Quality Assurance Director
Spinal Elements Inc.
3115 Melrose Dr., Suite 200
Carlsbad, CA 92010
760-607-1816
jlamothe@spinalelements.com |
| Date Prepared: | July 7, 2016 |
| Proprietary Name | Spinal Elements' Spinous Process Plate System |
| Common Name | Spinous Process Plate |
| Device Classification | 21 CFR Section 888.3050 |
| Classification Name | Spinal interlaminal fixation orthosis |
| Proposed Regulatory Class | Class II |
| Device Product Code | PEK |
Purpose of this 510(k)
This Traditional 510(k) seeks clearance for a new spinal system. The new devices have an identical intended use and fundamental scientific technology as the predicate.
Device Description
Spinal Elements' Spinous Process Plate System is comprised of a static plate and a translating plate for posterior fixation of the spine in order to achieve fusion. The plates are available in multiple sizes to accommodate various patient anatomies. Both the static plate and the translating plate present spikes to interface with the bone of the spinous processes. The barrel of the static plate passes through the insert of the translating plate such that, in their final position, the plates surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes. The spinous process plates are made from titanium alloy (Ti-6A1-4V) conforming to ASTM F136 with a nitinol spring conforming to ASTM F2063 and a coating of commercially pure titanium conforming to ASTM F1580. Additionally, the
4
plates feature a titanium coating on their medial surfaces as well as the initial portion of the barrel.
Indications for Use
Spinal Elements' Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. 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, and/or tumor. Spinal Elements' Spinous Process Plate System is not intended for stand-alone use.
Substantial Equivalence
The subject device is substantially equivalent to the predicate devices cleared in K151863 Reli SP Spinous Plating System (PRIMARY), K123246 CD HORIZON SPIRE and K100354 PrimaLOK sp Interspinous Fusion System.
Technological Characteristics
The subject device has equivalent technological characteristics to its predicates presented below through comparison in areas including labeling/indications for use, general design features, dimensions, function, materials and instrumentation to the following predicate devices:
- o Reli SP Spinous Plating System (K151863) - PRIMARY
- CD HORIZON SPIRE (K123246) ●
- PrimaLOK sp Interspinous Fusion System (K100354) o
Performance Data
No clinical testing was found to be necessary. Non-clinical performance testing included:
- Static Compression and Torsion testing per ASTM F 1717 o
- Dynamic Compression Testing per ASTM F 1717 ●
- Plate Dissociation per ASTM F1798 ●
- Pullout Testing ●
- Particulate Analysis per ASTM F1877
- Corrosion testing per ASTM F2129
- Austenitic finish (Af) functional testing o
All data indicates that the device will perform as intended.
Conclusion
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject device has been shown to be substantially equivalent to the aforementioned predicate devices cleared by FDA for commercial distribution in the United States.