(195 days)
Not Found
No
The summary describes a physical interbody fusion implant with a porous structure and various sizes and angles. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
This device is an intervertebral body fusion cage intended for the treatment of cervical and lumbar degenerative disc disease, which clearly indicates a therapeutic purpose.
No
Explanation: The device is an intervertebral body fusion cage intended for surgical implantation to facilitate spinal fusion and provide stabilization. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is composed of "interbody fusion implants" which are physical hardware devices intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The text clearly describes the STALIF and ACTILIF FLX™ devices as intervertebral body fusion cages intended for surgical implantation into the spine to facilitate bone fusion. They are used to treat degenerative disc disease and related conditions.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is mechanical support and facilitating bone growth within the body.
Therefore, the STALIF and ACTILIF FLX™ devices fall under the category of implantable medical devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The STALIF C FLX™ device is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients with previous non-fusion spinal surgery at the treated level may be treated. The device system is designed for use with autograft bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
The STALIF C FLX™ with lordotic angles greater than or equal to 10 degrees are required to be used with FDA-cleared supplemental fixation for use in the cervical spine.
The STALIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIF M FLX™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF M FLX™ with lordotic angles greater than or equal to 20 degrees are required to be used with FDA-cleared supplemental fixation for use in the lumbar spine.
The STALIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF L FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.
The STALIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated. These implants may be implants may be implanted via a laparoscopic or an open lateral approach. The STALIF Lateral-Oblique FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.
The ACTILIF C FLX™ is intended for spinal fusion procedures at multiple contiguous levels from the C2-C3 disc to the C7-T1 disc in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The ACTILIF C FLX™ is to be used in a patient who has had six weeks of non-operative treatment prior to implantation of the cage. Implants are intended to be packed with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients with previous non- fusion spinal surgery at the treated. The ACTILIF C FLX™ is intended to be used with a supplemental fixation system.
The ACTILIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the treated level may be treated. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine.
The ACTILIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine.
The ACTILIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, OVD, OVE
Device Description
The FLX™ Platform is composed of 8 different interbody fusion implant families:
- STALIF C FLX™
- STALIF M FLX™
- STALIF L FLX™ and STALIF Lateral-Oblique FLX™
- ACTILIF C FLX™
- ACTILIF M FLX™
- ACTILIF L FLX™ and ACTILIF Lateral-Oblique FLX™
The FLX™ Platform is a novel range of interbody fusion implants with a complex randomized lattice. The Implants retain all of the benefits of the STALIF® product family while taking advantage of the benefits of porous, laser sintered Ti6Al4V. With the recent advances in additive manufacturing, titanium implants are printed with a porous scaffold structure which reduces the stiffness of the device to potentially reduce subsidence and facilitate bone growth through and around the implant.
The FLX™ Platform is intended to be implanted between the vertebral bodies into the cleared disc space to help provide stabilization and height restoration and facilitate the interbody fusion process. The device is intended to be used with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). The devices are available in a variety of heights, lengths, and widths as well as different lordotic angles to provide surgeons with a wide array of solutions for the highly variable patient population. Surgical instrumentation has been previously developed for the STALIF® Platform and is compatible with the new devices.
In addition, interbody-only versions of the FLX™ devices are available in similar size ranges as the STALIF® versions. These devices are not designed to be used with the current STALIF® ABO screw constructs and are instead to be used with supplemental fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2/C3 disc space to the C7/T1 disc space), Lumbar spine (L2 to S1, L2 to L5)
Indicated Patient Age Range
Skeletally mature
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 worst case devices were subjected to mechanical testing included static compression, static compression-shear, dynamic compression, dynamic compression-shear, expulsion, subsidence per ASTM F2077-14 and F2267-04. Additional analyses were performed on wear debris particles to ensure the results were consistent with predicate devices. The results demonstrate that the devices are 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.
K150643, K150053, K130461, K170503, K122444, K140348, K163491
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.
Not Found
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
§ 888.3080 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On 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.
May 8, 2018
Centinel Spine, Inc. % Mr. Justin Eggleton Senior Director. Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K173347
Trade/Device Name: STALIF C FLX™, STALIF M FLX™, STALIF L FLX™, STALIF Lateral-Oblique FLX™, ACTILIF C FLX™, ACTILIF M FLX™, ACTILIF L FLXTM, and ACTILIF Lateral-Oblique FLXTM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP, OVD, OVE Dated: April 9, 2018 Received: April 9, 2018
Dear Mr. Eggleton:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K173347
Device Name STALIF C FLXTM
Indications for Use (Describe)
The STALIF C FLX™ device is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients with previous non-fusion spinal surgery at the treated level may be treated. The device system is designed for use with autograft bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
The STALIF C FLX™ with lordotic angles greater than or equal to 10 degrees are required to be used with FDA-cleared supplemental fixation for use in the cervical spine.
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
3
510(k) Number (if known) K173347
Device Name STALIF M FLXTM
Indications for Use (Describe)
The STALIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIF M FLX™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF M FLX™ with lordotic angles greater than or equal to 20 degrees are required to be used with FDA-cleared supplemental fixation for use in the lumbar spine.
X 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
4
510(k) Number (if known) K173347
Device Name STALIF L FLXTM
Indications for Use (Describe)
The STALIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF L FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.
X 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
5
510(k) Number (if known) K173347
Device Name STALIF Lateral-Oblique FLXTM
Indications for Use (Describe)
The STALIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated. These implants may be implants may be implanted via a laparoscopic or an open lateral approach. The STALIF Lateral-Oblique FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.
| 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
6
510(k) Number (if known) K173347
Device Name ACTILIF C FLXTM
Indications for Use (Describe)
The ACTILIF C FLX™ is intended for spinal fusion procedures at multiple contiguous levels from the C2-C3 disc to the C7-T1 disc in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The ACTILIF C FLX™ is to be used in a patient who has had six weeks of non-operative treatment prior to implantation of the cage. Implants are intended to be packed with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients with previous non- fusion spinal surgery at the treated. The ACTILIF C FLX™ is intended to be used with a supplemental fixation system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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
7
510(k) Number (if known) K173347
Device Name ACTILIF M FLXTM
Indications for Use (Describe)
The ACTILIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the treated. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine.
X 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
8
510(k) Number (if known) K173347
Device Name ACTILIF L FLXTM
Indications for Use (Describe)
The ACTILIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated. These devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
9
510(k) Number (if known) K173347
Device Name ACTILIF Lateral-Oblique FLXTM
Indications for Use (Describe)
The ACTILIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.
X 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
10
510(k) Summary
| Device Trade Name: | STALIF C FLXTM
STALIF M FLXTM
STALIF L FLXTM and STALIF Lateral-Oblique FLXTM
ACTILIF C FLXTM
ACTILIF M FLXTM
ACTILIF L FLXTM and ACTILIF Lateral-Oblique FLXTM |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380 |
| Contact: | Mrs. Jessica Staub
Director, Quality and Regulatory
Centinel Spine, Inc. |
| Prepared by: | Mr. Justin Eggleton
Senior Director, Spine Regulatory Affairs
Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K Street NW, Suite 1000
Washington, DC 20001
202.552.5800
jeggleton@mcra.com |
| Date Prepared: | May 8, 2018 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX, ODP, OVD, OVE |
| Primary Predicate: | The subject devices are substantially equivalent to the following
primary predicate device. |
Table 1: Primary Predicate Device
| Manufacturer | Device Name | K Number |
|---|---|---|
| Centinel Spine | STALIF TT™, STALIF MIDLINE®, MIDLINE | |
| II™, MIDLINE II-Ti™ | K150643 |
11
Additional Predicates:
In addition to the primary predicate device, additional predicate devices cited in this 510(k) are presented in the following table.
| Manufacturer | Device Name | K Number |
|---|---|---|
| Centinel Spine | STALIF C® and STALIF C-TiTM | K150053 |
| Centinel Spine | STALIF XTM (STALIF LTM) | K130461 |
| EIT Spine | EIT Cellular Titanium® Cervical Cage, EIT | |
| Cellular Titanium® PLIF Cages, EIT Cellular | ||
| Titanium® TLIF Cages, and EIT Cellular | ||
| Titanium® ALIF Cages | K170503 | |
| Eisertech | Eisertech Cervical Cage | K122444 |
| Eisertech | Eisertech Interbody Cage | K140348 |
| NuVasive | CoRoent® Small Interbody System | K163491 |
Table 2: Additional Predicate Devices
Indications for Use and Intended Use:
STALIF C FLXTM
The STALIF C FLX™ device is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients with previous non-fusion spinal surgery at the treated level may be treated. The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of nonoperative treatment prior to implantation of the cage.
The STALIF C FLX™ with lordotic angles greater than or equal to 10 degrees are required to be used with FDA-cleared supplemental fixation for use in the cervical spine.
STALIF M FLXTM
The STALIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
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The STALIF M FLX™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF M FLX™ with lordotic angles greater than or equal to 20 degrees are required to be used with FDA-cleared supplemental fixation for use in the lumbar spine.
STALIF L FLXTM
The STALIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF L FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.
STALIF Lateral-Oblique FLXTM
The STALIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF Lateral-Oblique FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.
ACTILIF C FLXTM
The ACTILIF C FLX™ is intended for spinal fusion procedures at multiple contiguous levels from the C2-C3 disc to the C7-T1 disc in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The ACTILIF C FLX™ is to be used in a patient who has had six weeks of non-operative treatment prior to implantation of the cage. Implants are intended to be packed with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients with previous non- fusion spinal surgery at the treated level may be treated. The ACTILIF C FLX™ is intended to be used with a supplemental fixation system.
ACTILIF M FLXTM
The ACTILIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc
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confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the treated level may be treated. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.
ACTILIF L FLXTM
The ACTILIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.
ACTILIF Lateral-Oblique FLXTM
The ACTILIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.
Device Description:
The FLXTM Platform is composed of 8 different interbody fusion implant families:
- STALIF C FLXTM ●
- STALIF M FLXTM ●
- STALIF L FLXTM and STALIF Lateral-Oblique FLXTM ●
- ACTILIF C FLXTM ●
- ACTILIF M FLXTM ●
- ACTILIF L FLXTM and ACTILIF Lateral-Oblique FLXTM ●
The FLX™ Platform is a novel range of interbody fusion implants with a complex randomized lattice. The Implants retain all of the benefits of the STALIF® product family while taking advantage of the benefits of porous, laser sintered Ti6Al4V. With the recent advances in additive manufacturing, titanium implants are printed with a porous scaffold structure which reduces the stiffness of the device to potentially reduce subsidence and facilitate bone growth through and around the implant.
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The FLX™ Platform is intended to be implanted between the vertebral bodies into the cleared disc space to help provide stabilization and height restoration and facilitate the interbody fusion process. The device is intended to be used with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). The devices are available in a variety of heights, lengths, and widths as well as different lordotic angles to provide surgeons with a wide array of solutions for the highly variable patient population. Surgical instrumentation has been previously developed for the STALIF® Platform and is compatible with the new devices.
In addition, interbody-only versions of the FLX™ devices are available in similar size ranges as the STALIF® versions. These devices are not designed to be used with the current STALIF® ABO screw constructs and are instead to be used with supplemental fixation.
Performance Testing Summary:
The worst case devices were subjected to mechanical testing included static compression, static compression-shear, dynamic compression, dynamic compression-shear, expulsion, subsidence per ASTM F2077-14 and F2267-04. Additional analyses were performed on wear debris particles to ensure the results were consistent with predicate devices. The results demonstrate that the devices are substantially equivalent to the predicate devices.
Substantial Equivalence:
The subject devices were demonstrated to be substantially equivalent to predicates cited in the table above with respect to indications, design, materials, function, manufacturing, and performance.
Conclusion:
The Centinel Spine STALIF C FLX™, STALIF M FLXIM, STALIF L FLX™, STALIF Lateral-Oblique FLX™, ACTILIF C FLX™, ACTILIF M FLX™, ACTILIF L FLX™ and ACTILIF Lateral-Oblique FLX™ are substantially equivalent to previously cleared devices with respect to its indications for use, design, function, materials, and performance.