(56 days)
Not Found
No
The description focuses on the mechanical design and intended use of a physical implant and surgical instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a fixation plate intended for use in the non-cervical spine to achieve supplemental fusion in conditions like degenerative disc disease, spondylolisthesis, trauma, and tumor, which are medical conditions indicating a therapeutic purpose.
No
The device description clearly states "The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1-S1)." This indicates it is a therapeutic device used for physical fixation and fusion, not for diagnosing conditions.
No
The device description clearly states it is a "one-piece bilateral locking plate device" composed of "titanium 6Al-4V alloy," indicating it is a physical implant, 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).
- Device Description: The UniVise™ Spinous Process Fixation Plate is a physical implant designed to be surgically attached to the spinous processes of the spine. It is a mechanical device used for fixation and stabilization within the body.
- Intended Use: The intended use is for supplemental fixation in spinal fusion procedures to treat various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purposes 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); spondylolisthesis; trauma (i.e. fracture or dislocation); and/or tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft and is not intended for stand alone use
Product codes
PEK
Device Description
The UniVise™ Spinous Process Fixation Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The S.P.F.P is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6Al-4V alloy. The UniVise™ Spinous Process Fixation Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the S.P.F.P is available for both conventional and minimally-invasive surgical procedures. When the UniVise™ Spinous Process Fixation Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1), lumbosacral spine (L2-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
The purpose of this 510(k) is to modify the Surgical Technique for the subject UniVise™ Spinous Process Fixation Plate. No device design changes have been made to the predicate VertiFlex® Spinous Process Fixation Plate (commercially distributed as the UniVise™ Spinous Process Fixation Plate by Stryker Spine) previously cleared in K122509. No new performance data was generated for the purpose of this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
.
| 510(k) Summary: UniVise™ Spinous Process Fixation Plate | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Kristen Meany, MS, CQA, RAC |
| Project Manager, Regulatory Affairs | |
| Phone: 201-760-8070 | |
| Fax: 201-962-4070 | |
| Email: kristen.meany@stryker.com | |
| Date Prepared | September 20 2013 |
| Trade Name | UniVise™ Spinous Process Fixation Plate |
| Common Name | Spinous Process Fixation Plate |
| Proposed Class | Class II |
| Classification Name | |
| and Number | Spinal interlaminal fixation orthosis, 21 C.F.R. 888.3050 |
| Product Code | PEK |
| Predicate Devices | The UniVise™ Spinous Process Fixation Plate was shown to be |
| substantially equivalent to the devices listed below: | |
| • Affix® Spinous Process Plate System, NuVasive Incorporated, | |
| K131238 | |
| • VertiFlex® Spinous Fixation Plate, VertiFlex Incorporated, | |
| K122509 | |
| Device Description | The UniVise™ Spinous Process Fixation Plate is a one-piece bilateral |
| locking plate device which attaches to the posterior non-cervical spine | |
| by securely grasping two adjacent spinous processes. The S.P.F.P is | |
| available in multiple sizes to accommodate different anatomical | |
| requirements, and it is composed entirely of titanium 6Al-4V alloy. The | |
| UniVise™ Spinous Process Fixation Plate may be implanted by either | |
| conventional surgical methods, or via minimally-invasive techniques. | |
| Proprietary manual instrumentation for implantation of the S.P.F.P is | |
| available for both conventional and minimally-invasive surgical | |
| procedures. When the UniVise™ Spinous Process Fixation Plate is used | |
| as supplemental fixation in interbody fusion procedures, its use is | |
| limited to the treatment of degenerative disc disease (DDD) of the | |
| lumbosacral spine (L2-S1). | |
| Intended Use | The UniVise™ Spinous Process Fixation Plate is a posterior, non- |
| pedicle supplemental fixation device intended for use at a single level in | |
| the non-cervical spine (T1-S1). It is intended for plate | |
| fixation/attachment to spinous processes for the purposes 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); | |
| spondylolisthesis; trauma (i.e. fracture or dislocation); and/or tumor. | |
| The UniVise™ Spinous Process Fixation Plate is intended for use with | |
| bone graft and is not intended for stand alone use |
.
1
.
,
| Summary of the Technological
Characteristics | As was established in this submission, the UniVise™ Spinous
Process Fixation Plate is substantially equivalent and has
equivalent technological characteristics to other predicate
devices cleared by the FDA as demonstrated through
comparison in areas such as design, labeling, intended use,
material composition, and function. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of the Performance
Data | The purpose of this 510(k) is to modify the Surgical
Technique for the subject UniVise™ Spinous Process
Fixation Plate. No device design changes have been made to
the predicate VertiFlex® Spinous Process Fixation Plate
(commercially distributed as the UniVise™ Spinous Process
Fixation Plate by Stryker Spine) previously cleared in
K122509. No new performance data was generated for the
purpose of this submission. |
| Conclusions | The UniVise™ Spinous Process Fixation Plate is as safe and
effective as the predicate devices as it has the same intended
uses and similar indications for use, technological
characteristics, and principles of operation as its predicate
devices. |
,
.
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, symbolizing strength and freedom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle, emphasizing the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2013
Stryker Spine Kristen Meany, MS, CQA, RAC Project Manager, Regulatory Affairs 2 Pearl Court Allendale, New Jersey 07401
Re: K132968
Trade/Device Name: UniViseTM Spinous Process Fixation Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: September 26, 2013 Received: September 27, 2013
Dear Ms. Meany:
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. Isting 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 .
3
Page 2 - Kristen Meany, MS, CQA, RAC
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,
Ronaldillean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K132968
Device Name: Stryker Spine UniVise™ Spinous Process Fixation Plate
Indications for Use:
The UniVise™ Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes 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); spondylolisthesis; trauma (i.e. fracture or dislocation); and/or tumor. The UniVise™ Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132968
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