(113 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural stability of the implant and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an Anterior Cervical Fixation System indicated for interbody fusion procedures to treat degenerative disc disease, which involves treating a disease state and restoring function.
No
The device description indicates that the Unison-C Anterior Cervical Fixation System is a physical implant (intervertebral body devices and screws) used for cervical interbody fusion procedures to provide structural stability, not to diagnose a condition.
No
The device description clearly states that the Unison-C Anterior Cervical Fixation System consists of physical implants (intervertebral body devices and screws) made of materials like polymer and titanium alloy, and includes surgical instrumentation. This indicates it is a hardware medical device, not software-only.
Based on the provided text, the Unison-C Anterior Cervical Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The description of the Unison-C system clearly states it is an implantable device used for surgical fixation in the cervical spine.
- The intended use and device description focus on structural support and fusion within the body. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- The performance studies described are mechanical tests (static and dynamic testing of the implant's strength and stability), not studies related to the accuracy or performance of a diagnostic test.
Therefore, the Unison-C Anterior Cervical Fixation System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Unison-C Anterior Cervical Fixation System is to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is implanted via an anterior approach. The Unison-C Anterior Cervical Fixation System must be used with two of the provided bone screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Product codes
OVE
Device Description
The Unison-C Anterior Cervical Fixation System is intended for stand-alone cervical interbody fusion procedures and does not require use of supplemental fixation. The Unison-C Anterior Cervical Fixation System is used to provide structural stability in skeletally mature individuals following discectomy. The Unison-C System implants consist of intervertebral body devices (with an integrated locking mechanism and radiographic pins) and screws. The intervertebral body device component is manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone), the radiographic markers consist of ASTM F560 tantalum, and the screws and locking mechanism are comprised of ASTM F136 Titanium Alloy. The Unison-C Anterior Cervical Fixation System is supplied with instrumentation that are necessary for use to facilitate the insertion and removal of the implants as well as general manual surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, one level from C2 to T1
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
The Unison-C Anterior Cervical Fixation System has been tested in the following test modes:
- Static axial compression per ASTM F2077-11
- Static compressive shear per ASTM F2077-11
- Static torsion per ASTM F2077-11
- Static Subsidence per ASTM F2267-04
- Dynamic axial compression fatigue per ASTM F2077-11
- Dynamic compressive shear per ASTM F2077-11
- Dynamic torsion per ASTM F2077-11
- Locking Mechanism Disassociation Testing
- Screw Push-Out
The results of this non-clinical testing show that the Unison-C Anterior Cervical Fixation System is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K121151, K142079, K113796, K113559, K102606, K142218
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design, symbolizing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2016
Pioneer Surgical Technology, Incorporated dba RTI Surgical, Incorporated % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K152793
Trade/Device Name: Unison-C Anterior Cervical Fixation System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 18, 2015 Received: December 21, 2015
Dear Mr. Maxwell:
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
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/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 yours,
Lori A. Wiggins -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) K152793
Device Name
Unison-C Anterior Cervical Fixation System
Indications for Use (Describe)
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Unison-C Anterior Cervical Fixation System is to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is implanted via an anterior approach. The Unison-C Anterior Cervical Fixation System must be used with two of the provided bone screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ------------------------------------------------ | ----------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
| Submitter's Name: | Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. |
|---|---|
| Submitter's Address: | 375 River Park Circle |
| Marquette, MI 49855 | |
| Submitter's Telephone: | 906.225. 5861 |
| Company Contact Person: | Sarah Pleaugh |
| Regulatory Affairs Specialist | |
| Official Contact Person: | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 12 January 2015 |
| Trade or Proprietary Name: | Unison-C Anterior Cervical Fixation System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification: | Class II per 21 CFR §888.3080 Device Classification |
| Product Code: | OVE |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Unison-C Anterior Cervical Fixation System is intended for stand-alone cervical interbody fusion procedures and does not require use of supplemental fixation. The Unison-C Anterior Cervical Fixation System is used to provide structural stability in skeletally mature individuals following discectomy. The Unison-C System implants consist of intervertebral body devices (with an integrated locking mechanism and radiographic pins) and screws. The intervertebral body device component is manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone), the radiographic markers consist of ASTM F560 tantalum, and the screws and locking mechanism are comprised of ASTM F136 Titanium Alloy. The Unison-C Anterior Cervical Fixation System is supplied with instrumentation that are necessary for use to facilitate the insertion and removal of the implants as well as general manual surgical instruments.
INDICATIONS FOR USE
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Unison-C Anterior Cervical Fixation System is to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is implanted via an anterior approach. The Unison-C Anterior Cervical Fixation System must be used with two of the provided bone screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
4
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:
- . Indications for Use
- . Materials of manufacture
- Principle of operation .
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K121151 | Pro-Link Cervical Spacer | Link Spine | Primary |
| K142079 | STALIF C® | Centinel Spine, Inc. | Additional |
| K113796 | Solitaire®-C Cervical Spacer System | Biomet Spine | Additional |
| K113559 | Cervical Interbody Fusion System ROI-C | LDR Spine USA | Additional |
| K102606 | AVS® Anchor-C Cervical Cage System | Stryker Spine | Additional |
| K142218 | COALITION AGX | Globus | Additional |
PERFORMANCE DATA
The Unison-C Anterior Cervical Fixation System has been tested in the following test modes:
- Static axial compression per ASTM F2077-11 ●
- Static compressive shear per ASTM F2077-11
- Static torsion per ASTM F2077-11
- Static Subsidence per ASTM F2267-04 ●
- Dynamic axial compression fatigue per ASTM F2077-11 .
- Dynamic compressive shear per ASTM F2077-11 ●
- Dynamic torsion per ASTM F2077-11 ●
- Locking Mechanism Disassociation Testing .
- Screw Push-Out .
The results of this non-clinical testing show that the Unison-C Anterior Cervical Fixation System is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Unison-C Anterior Cervical Fixation System is substantially equivalent to the predicate device.