(304 days)
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 fashion via an anterior approach at the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
The Wenzel Spine VariLift® Interbody Fusion System (VariLift®-L/LX and VariLift®-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
VariLift®-L/LX is designed to be implanted bi-laterally via a posterior (PLF) approach or as a single device via a transverse (TLIF) approach. VariLift®-L/LX may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. VariLift®-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift®-A may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
VariLift-LX Interbody Fusion Device: The VariLift-LX is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral endplates. The VariLift-LX devices are made of titanium alloy (Ti6AI4V ELI per ASTM F136) and are provided sterile. The VariLift-LX Interbody Fusion Device may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.
VariLift-C Interbody Fusion Device: The Wenzel Spine VariLift Cervical Interbody Fusion System is a self-tapping, expandable device 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-6A1-4V 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 sterile.
This document is a 510(k) summary for the VariLift®-LX Interbody Fusion System and the VariLift®-C Interbody Fusion System. It primarily establishes substantial equivalence to predicate devices and does not describe acceptance criteria or a specific study proving the device meets those criteria in the way a diagnostic AI device would.
However, I can extract the information provided about performance testing to infer how the device's mechanical performance was assessed.
Here's a breakdown of the available information regarding acceptance criteria and performance, as best as can be inferred from a device clearance document focused on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Strict acceptance criteria per se (e.g., sensitivity, specificity, or specific numerical thresholds for clinical outcomes) are not explicitly stated in this 510(k) summary, as it's for a physical implant device designed for mechanical stability and fusion, not a diagnostic AI system.
However, the "performance" described pertains to mechanical testing compared to predicate devices for substantial equivalence. The implicit "acceptance criteria" appear to be that the subject devices perform similarly or equivalently to the predicate devices in biomechanical tests.
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Performance | VariLift®-LX Interbody Fusion Device: Substantially equivalent to predicate VariLift®-L (K151900) in intended use, Indications for Use, materials, principles of operation, and fundamental technology. |
| VariLift®-C Interbody Fusion Device: Substantially equivalent to predicate VariLift®-C (K120603) in intended use, Indications for Use, materials, principles of operation, and fundamental technology. Non-clinical testing on the smallest new size demonstrated substantial equivalence to the predicate's smallest size in: - Static compression - Compression shear - Torsion testing - Dynamic compression testing (per ASTM 2077-14) - Subsidence testing (per ASTM F2267-04) - Expulsion testing |
2. Sample Size Used for the Test Set and Data Provenance
This document describes mechanical testing of physical device samples, not testing with a "test set" of data in the context of an AI/diagnostic device.
- Sample Size for Test Set: Not applicable in the context of a data-driven test set. For the VariLift-C, testing was conducted on "the smallest new size," implying a limited number of physical samples of that specific device configuration. The exact number of physical devices tested is not specified, but it would typically be a small, statistically justified sample for mechanical tests.
- Data Provenance: Not applicable in the context of data. The "provenance" here is the result of laboratory mechanical testing of physical implants.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical implant, not a diagnostic AI device requiring expert ground truth for image or data interpretation.
4. Adjudication Method
Not applicable. This is not a study involving human interpretation or annotation that would require an adjudication method.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device clearance for an implant, not an AI diagnostic tool that undergoes MRMC studies to assess improvement in human reader performance.
6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)
Not applicable. This is a physical interbody fusion device, not an algorithm.
7. Type of Ground Truth Used
- For the VariLift-C, the "ground truth" for mechanical performance was established by comparing its performance to established ASTM standards (ASTM 2077-14 and ASTM F2267-04) and to the mechanical performance of the legally marketed predicate device (VariLift-C Interbody Fusion Device, K120603). The implication is that if it performs comparably or better than the predicate device and meets relevant standard recommendations, it's considered safe and effective.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
In summary: This document is a 510(k) summary for interbody fusion systems, emphasizing substantial equivalence to predicate devices through similar design, materials, and biomechanical performance. It does not contain the types of information typically found in a submission for an AI-powered diagnostic device, such as specific clinical outcome acceptance criteria, sample sizes for data sets, or ground truth established by experts. The "study" described is a series of non-clinical, mechanical tests designed to demonstrate that the new devices perform acceptably and comparably to existing, cleared devices.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). To the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 5, 2021
Wenzel Spine, Inc. Erik Emstad VP of Product Development 1130 Rutherford Lane, Suite 200 Austin, Texas 78753
Re: K180822
Trade/Device Name: VariLift®-LX Interbody Fusion System, VariLift®-C Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP
Dear Erik Emstad:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter sent January 28, 2019. Specifically, FDA is updating this SE Letter because incorrect SE elements were emailed in the original communication.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, Brent.Showalter@fda.hhs.gov.
Sincerely,
Brent Showalter -S
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA. On the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo is in blue and features the FDA acronym in a blue square, followed by the full name of the agency in a larger, bolder font.
August 5, 2021
Wenzel Spine, Inc. Erik Emstad VP of Product Development 1130 Rutherford Lane, Suite 200 Austin, Texas 78753
Re: K180822
Trade/Device Name: VariLift®-LX Interbody Fusion System, VariLift®-C Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: January 11, 2019 Received: January 15, 2019
Dear Erik Emstad:
This letter corrects our substantially equivalent letter of January 28, 2019.
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180822
Device Name
VariLift®-C Interbody Fusion System
Indications for Use (Describe)
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 fashion via an anterior approach at the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
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) |
|---|---|
| ------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180822
Device Name
VariLift®-LX Interbody Fusion System
Indications for Use (Describe)
The Wenzel Spine VariLift® Interbody Fusion System (VariLift®-L) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
VariLift@-L/LX is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift®-L/LX may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. VariLift@-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift@-A may be implanted with or without supplemental fixation and is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft to facilitate 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.#### This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/5/Picture/1 description: The image shows the logo for Wenzel Spine. The word "wenzel" is in blue, with a yellow arc above the "zel" portion of the word. The word "spine" is also in blue, and is to the right of the word "wenzel". Below the words is the phrase "simple. dependable. proven."
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | January 25, 2019 |
|---|---|
| Applicant/Sponsor: | Wenzel Spine, Inc.1130 Rutherford Lane, Suite 200Austin, TX 78753 |
| Contact Person: | Erik EmstadVice President of Product DevelopmentPhone : 952-221-3213Fax : 512-469-0604Email : eemstad@wenzelspine.com) |
| Trade Name:Common Name:Device Class:Classification Name:Device Panel: | VariLift®-LX Interbody Fusion SystemInterbody Fusion Device (MAX)Class IIMAX, 888.3080 – Intervertebral Fusion Device with Bone Graft, LumbarOrthopedic |
| Trade Name:Common Name:Device Class:Classification Name:Device Panel: | VariLift®-C Interbody Fusion SystemIntervertebral Body Fusion Device (ODP)Class IIODP, 888.3080 – Intervertebral Fusion Device with Bone Graft, CervicalOrthopedic |
Device Description & Technological Characteristics
VariLift-LX Interbody Fusion Device
The VariLift-LX is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral endplates. The VariLift-LX devices are made of titanium alloy (Ti6AI4V ELI per ASTM F136) and are provided sterile. The VariLift-LX Interbody Fusion Device may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.
VariLift-C Interbody Fusion Device
The Wenzel Spine VariLift Cervical Interbody Fusion System is a self-tapping, expandable device 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-6A1-4V 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 sterile.
Indications for Use
VariLift-LX Interbody Fusion Device
The Wenzel Spine VariLift® Interbody Fusion System (VariLift®-L/LX and VariLift®-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous
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Image /page/6/Picture/1 description: The image shows the logo for Wenzel Spine. The words "wenzel spine" are written in blue, with a yellow arc above the "el sp" portion of the text. Below the company name, the words "simple. dependable. proven." are written in a smaller font.
levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
VariLift®-L/LX is designed to be implanted bi-laterally via a posterior (PLF) approach or as a single device via a transverse (TLIF) approach. VariLift®-L/LX may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. VariLift®-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift®-A may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
VariLift-C Interbody Fusion Device
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 fashion via an anterior approach at the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graff. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral fusion device.
Predicate Devices
VariLift-LX Interbody Fusion Device
Primary Predicate: VariLift®-L Interbody Fusion Device, K151900 Additional Predicate: Amendia Interbody Fusion Devices, K160924
VariLift-C Interbody Fusion Device
Primary Predicate: VariLift-C Interbody Fusion Device, K120603 Additional Predicate: Amendia Interbody Fusion Devices, K160924
Summary of Technological Characteristics
VariLift-LX Interbody Fusion Device
The technological characteristics of the subject VariLift-LX Interbody Fusion Device remain the same as, or similar to, the predicate VariLift-L Interbody Fusion Device (K151900) in regards to intended use, Indications for Use, design, manufacturing methods, fundamental technology, materials, and principles of operation.
VariLift-C Interbody Fusion Device
The technological characteristics of the subject VariLift-C Interbody Fusion Device remain the same as, or similar to, the predicate VariLift-C Interbody Fusion Device (K120603) in regards to intended use, Indications for Use, design, manufacturing methods, fundamental technology, materials, and principles of operation.
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Image /page/7/Picture/1 description: The image shows the logo for Wenzel Spine. The words "wenzel spine" are in blue, with a yellow arc over the "el sp" portion of the name. Below the name, in smaller font, are the words "simple. dependable. proven."
Summary of Performance Testing
VariLift-LX Interbody Fusion Device
The substantial equivalence of the VariLift-LX Interbody Fusion Device to the predicate devices is evidenced by having the same, or similar, intended use, Indications for Use, materials, principles of operation, and fundamental technology.
VariLift-C Interbody Fusion Device
The substantial equivalence of the VariLift-C Interbody Fusion Device to the predicate devices is evidenced by having the same, or similar, intended use, Indications for Use, materials, principles of operation, and fundamental technology. Non-clinical testing was conducted on the smallest new size to determine substantial equivalence to the predicate VariLift-C smallest size.
Static compression, compression shear, torsion testing, and dynamic compression testing per ASTM 2077-14: "Test Methods for Intervertebral Body Fusion Devices"; subsidence testing per ASTM F2267-04: "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression"; and expulsion testing demonstrated that the subject VariLift-C Interbody Fusion Devices are substantially equivalent to the predicate devices in terms of mechanical performance.
Conclusion
VariLift-LX Interbody Fusion Device
Based on the comparison to the predicate devices, the subject VariLift-LX Interbody Fusion Device has been shown to be substantially equivalent to legally marketed predicate devices.
VariLift-C Interbody Fusion Device
Based on the comparison to the predicate devices, the subject VariLift-C Interbody Fusion Device has been shown to be substantially equivalent to legally marketed predicate devices.
§ 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.