(231 days)
P980048 S003, P980048, K091088
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
Explanation: The device is used to facilitate intervertebral body fusion in the cervical spine for patients with degenerative disc disease, which directly addresses a medical condition to restore function.
No
The device is an intervertebral fusion system designed to facilitate fusion in the cervical spine, not to diagnose a condition. Its function is therapeutic/surgical.
No
The device description explicitly states the device is composed of Titanium-6AI-4V ELI alloy and is a physical implant (expandable devices with an interior sliding wedge). This indicates it is a hardware medical device, not software-only.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Wenzel Spine VariLift Cervical Interbody Fusion System is a physical implant designed to be surgically placed in the cervical spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: The description focuses on the device's mechanical properties, materials, and surgical placement. There is no mention of it being used to analyze samples or provide diagnostic information.
Therefore, this device falls under the category of a surgical implant or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Wenzel Spine VariLift Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
Product codes
ODP
Device Description
The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6AI-4V ELI alloy that conforms to ASTM F136.
The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.
The device is supplied in an appropriately labeled sterile packaging.
The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 to C7 disc levels
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)
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with l ASTM F2077-03
- Static shear testing, conducted in accordance with ASTM F2077-03 "
- Static and dynamic torsion testing, conducted in accordance with ASTM -F2077-03
- Expulsion testing, conducted in accordance with ASTM Draft Standard F--04.25.02.02
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P980048 S003, P980048, K091088
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
, 111123
Wenzel Spine VariLift Cervical Interbody Fusion System
510(k) Summary of Safety and Effectiveness
| SUBMITTED BY | Wenzel Spine |
|---|---|
| 206 Wild Basin Rd | |
| Building A, Suite 203 | |
| Austin, TX 78746 |
| ESTABLISHMENT | 3008009850 |
|---|---|
| REGISTRATION NUMBER |
CONTACT PERSON Sourabh Mishra Chief Technology Officer Phone: 512-501-4017 Fax: 512-469-0604
- SUBMISSION PREPARED BY J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 ortho.medix@sbcglobal.net Phone: 512-388-0199 Fax: 512-692-3699
- April 12, 2011 DATE PREPARED
CLASSIFICATION NAME ODP 888.3080 - Intervertebral Fusion Device with Bone Graft, Cervical
Intervertebral Body Fusion Device COMMON NAME
VariLift Interbody Fusion System (VariLift-C) PROPRIETARY NAME
IDENTIFICATION OF PREDICATES
BAK®/C Vista Cage (P980048 S003) BAK®/Cervical Interbody Fusion (P980048) LDR Interbody Fusion System (K091088)
DEVICE DESCRIPTION
The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6AI-4V ELI alloy that conforms to ASTM F136.
The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.
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KIIII 23
The device is supplied in an appropriately labeled sterile packaging.
The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The VariLift Cervical Interbody Fusion System is substantially equivalent to the BAK®/C Vista Cage in terms of intended use, design, and materials used. The table below compares the features and characteristics of the VariLift Cervical Interbody Fusion System to these predicate devices.
| Items | VariLift Cervical Interbody Fusion System | BAK®/C Vista Interbody Fusion System |
|---|---|---|
| Sponsor | Wenzel Spine | Zimmer |
| 510(K) Number | N/A | P980048 S003 |
| Indications for Use | Per FDA Guidance | Per FDA Guidance |
| Material | Ti-6Al-4V alloy per ASTM F136 | PEEK Optima LT1 |
| Implant Levels | One Level | Once Level |
| # Implants per level | Single or Pairs | Single or Pairs |
| Supplemental Fixation | With Supplemental Fixation | With or Without Supplemental Fixation |
INDICATIONS:
The Wenzel Spine VariLift Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.
The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
DISCUSSION OF NON-CLINICAL TESTING
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with l ASTM F2077-03
- Static shear testing, conducted in accordance with ASTM F2077-03 "
- Static and dynamic torsion testing, conducted in accordance with ASTM -F2077-03
- Expulsion testing, conducted in accordance with ASTM Draft Standard F--04.25.02.02
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KIII23
CONCLUSIONS
The subject and predicate devices share the same intended use, implant design and material of manufacture. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The nonclinical and clinical test results demonstrate that the VariLift Cervical Interbody Fusion System is substantially equivalent to the predicate devices and support the use of VariLift-C with supplemental fixation.
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is black and appears to be part of a larger document or logo. To the left of the text is a graphic of three diagonal lines.
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 8 2011
Wenzel Spine % The OrthoMedix Group, Inc. Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K111123
Trade/Device Name: Wenzel Spine VariLift Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 9, 2011 Received: November 14, 2011
Dear Mr. Webb:
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. Iisting 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
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Page 2 - Mr. J. D. Webb
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRHOffices/ucm115809.html 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Fer. Piffner
Dec. 66.
Mark N. Melkerso Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 111 123
INDICATIONS FOR USE
510(k) Number (if known):
Wenzel Spine VariLift Cervical Interbody Fusion System Device Name:
Indications for Use:
The Wenzel Spine VariLift Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIIII23 510(k) Number_
2720 Bee Cave Road Austin, Texas 78746 Wenzel Spine
Phone: 512-501-40 Fax: 512-469-0604
.1061