(98 days)
No
The device description and intended use are purely mechanical, and there is no mention of AI or ML in the provided text.
Yes
The device is intended to treat multiple conditions of the cervical spine, such as degenerative disc disease, spondylolisthesis, and trauma, by providing stabilization as an adjunct to fusion.
No
The device, uNion™ Cervical Plate System, is an implantable medical device designed to provide stabilization of the anterior cervical spine. Its purpose is to physically support the spine until fusion is achieved, not to diagnose medical conditions.
No
The device description clearly states it is an anterior cervical plate and screw system, which are physical hardware components intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the uNion™ Cervical Plate System is for "anterior fixation of the cervical spine" and is used to "provide stabilization of the anterior cervical spine as an adjunct to fusion." This describes a surgical implant used directly on a patient's body.
- Device Description: The description details a "anterior cervical plate and screw system" with components like plates and screws. These are physical devices implanted during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) 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. This device does not perform any such tests on biological samples.
The information provided describes a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The uNion™ Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
Product codes
KWQ
Device Description
uNion™ is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips, one- through four-level standard plates having lengths from 10mm to 84mm and one- and two-level midline plates having lengths from 10mm to 46mm. Both the standard and the midline plates incorporate a pivoting insert which functions as an anti-back out mechanism. The devices are sold non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
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)
Mechanical testing of worst case uNion™ constructs included static and dynamic compression bending and static torsion according to ASTM F1717. The mechanical test results demonstrate that uNion™ performance is substantially equivalent to the predicate devices.
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.
Zavation Cervical Plate System (Zavation LLC - K130030), Zavation Cervical Plate System (Zavation LLC – K112533), MaxAn® Anterior Cervical Plate System (Biomet Spine LLC – K080646, K133518 and Uniplate Anterior Cervical Plate (DePuy Spine – K042544)
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.
Cervical Spine Locking Plate (CSLP) (Synthes Spine - K945700, K000536, K000742)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2015
ulrich medical USA Mr. Hans Stover President & CEO 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K150666
Trade/Device Name: uNion™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 2, 2015 Received: June 4, 2015
Dear Mr. Stover:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name uNion™ Cervical Plate System
Indications for Use (Describe)
The uNion™ Cervical Plate System is intentior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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510(k) Summary
Image /page/3/Picture/1 description: The image shows the logo for Ulrich medical USA. The logo consists of the word "Ulrich" in a bold, sans-serif font, with the "U" stylized to appear as if it is emerging from a black square. Below the word "Ulrich" are the words "medical USA" in a smaller, sans-serif font.
| Date: | 16 June 2015 |
|---|---|
| Sponsor: | ulrich medical USA, Inc. |
| 18221 Edison Avenue | |
| Chesterfield, MO 63005 | |
| (636) 519-0268 Office | |
| (636) 519-0271 Fax | |
| Contact Person: | Hans Stover, President & CEO |
| Proposed Trade Name: | uNion™ Cervical Plate System |
| Common Name: | Anterior cervical plate system |
| Device Classification: | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation: | 888.3060 |
| Device Product Code: | KWQ |
| Device Description: | uNion™ is an anterior cervical plate and screw system used to provide |
| mechanical support across implanted level(s) in the cervical spine until | |
| fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed | |
| and variable screws having self-tapping, self-drilling or self-drilling/self- | |
| tapping tips, one- through four-level standard plates having lengths from | |
| 10mm to 84mm and one- and two-level midline plates having lengths from | |
| 10mm to 46mm. Both the standard and the midline plates incorporate a | |
| pivoting insert which functions as an anti-back out mechanism. The devices | |
| are sold non-sterile. | |
| Indications for Use: | The uNion™ Cervical Plate System is intended for anterior fixation of the |
| cervical spine (C2 to T1). The system is to be used to provide stabilization | |
| of the anterior cervical spine as an adjunct to fusion for the treatment of | |
| degenerative disc disease (defined as neck pain of discogenic origin with | |
| the degeneration of the disc confirmed by history and radiographic studies), | |
| spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal | |
| stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or | |
| failed previous fusion. | |
| Materials: | uNion™ components are manufactured from Ti-6Al-4V ELI titanium alloy |
| (ASTM F136). | |
| Predicate Devices: | Primary: Zavation Cervical Plate System (Zavation LLC - K130030) |
| Additional: Zavation Cervical Plate System (Zavation LLC – K112533), | |
| MaxAn® Anterior Cervical Plate System (Biomet Spine LLC – K080646, | |
| K133518 and Uniplate Anterior Cervical Plate (DePuy Spine – K042544) | |
| Reference: Cervical Spine Locking Plate (CSLP) (Synthes Spine - | |
| K945700, K000536, K000742) | |
| Performance Data: | Mechanical testing of worst case uNion™ constructs included static and |
| dynamic compression bending and static torsion according to ASTM F1717. | |
| The mechanical test results demonstrate that uNion™ performance is | |
| substantially equivalent to the predicate devices. | |
| Technoloqical | |
| Characteristics: | The uNion™ cervical plate system possesses the same technological |
| characteristics as one or more of the predicate devices. These include: | |
| intended use (as described above) | |
| basic design (plate and screw configuration), | |
| material (titanium alloy), | |
| sizes (dimensions are comparable to those offered by the predicate | |
| systems) and | |
| The fundamental scientific technology of the uNion™ cervical plate system | |
| is the same as previously cleared devices. | |
| Conclusion: | The uNion™ cervical plate system possesses the same intended use and |
| technological characteristics as the predicate devices. Therefore uNion™ is | |
| substantially equivalent for its intended use. |
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