(78 days)
Not Found
No
The summary describes a physical medical device (spinal cages and bone graft substitute) and its intended use, manufacturing process, and performance studies. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for intervertebral body fusion to treat cervical and lumbar degenerative disc disease, relieve symptoms like radiculopathy, myelopathy, and pain, and facilitate bone fusion, directly satisfying the definition of a therapeutic device.
No
The device is an intervertebral body fusion device (cages and bone graft substitutes) intended for surgical implantation to promote fusion, not for diagnosing conditions. While diagnosis is mentioned as a prerequisite for patient selection (e.g., "confirmed by imaging studies"), the device itself does not perform diagnostic functions.
No
The device description clearly states that the CONDUIT™ Technology platform is a portfolio of 3D-printed porous titanium interbody devices, which are physical implants. The document also describes bone graft substitutes and a cannula, all of which are hardware components.
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 description clearly states that the CONDUIT™ Cervical Cages and FIBERGRAFT™ BG Putty are implants used for spinal fusion procedures. They are physically placed within the body to stabilize the spine and facilitate bone growth.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens outside of the body.
The device is a surgical implant used for structural support and bone fusion within the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CONDUIT™ Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior cervical in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiculopathy, myelopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - Tl. The CONDUIT™ Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. CONDUIT™ Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or cortiocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
The CONDUIT™ ALIF Cages with a microscopic roughened surface and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.
The CONDUIT™ TLIF Cages with a microscopic roughened surface and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by Fusion to facilitate fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
The CONDUIT™ LLF Cages with a microscopic roughened surface and micro and nano-scale features is indicated for interverebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S I. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade 1 soondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and or allogeneic bone graft comprised of carticocancellous bone graft, or a bone void filler as cleared by PDA for use in intervertebral body fusion to facilitate fusion. CONDUIT™ LLIF Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The CONDUIT™ TPLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogeneic bone graft comprised of cancellous, and or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with desence (DD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients of nonoperative treatment prior to treatment with the devices.
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
FIBERGRAFT™ BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
FIBERGRAFTIM BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
FIBERGRAFT™ BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be obtain rigid stabilization.
The GPS Cannula is intended for use only with FIBERGRAFT™BG Putty GPS and no other products.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX, MQV
Device Description
The CONDUIT™ Technology platform is a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal/Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).
The CONDUIT™ Cages are made from Ti-6A1-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous, or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion.
The 3D Printed CONDUIT™ Cages have a microscopic roughened surface with micro and nanoscale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.
The FIBERGRAFT™ BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), Lumbar spine (L2-S1), posterolateral spine, intervertebral disc space, extremities, pelvis
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use
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 performance of the CONDUIT™ Cervical and Lumbar Cages and the FIBERGRAFTTM BG Putty have been assessed individually within their respective submissions (K201605, and K170306). Clinical data has been utilized to demonstrate the performance and safety of the expanded indications for use, which includes the use of the CONDUIT™ Cages with FIBERGRAFT™ BGPutty. The clinical data includes radiographic and clinical outcomes from a retrospective study and two investigator-initiated studies. The data provided includes 178 subjects and was collected from multiple sites across the United States (CA, TX, FL) to capture a variety of populations with diverse gender and racial/ethnic backgrounds that is representative of the intended users of the subject devices. The results of the data support the performance of the subject devices in intervertebral body fusion based on fusion and adverse event rates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fusion and adverse event rates.
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.
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
October 15, 2022
Image /page/0/Picture/1 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.
DePuy Spine % Justin Eggleton Vice President, Spine Regulatory Affairs MCRA LLC 803 7th St NW Washington, District of Columbia 20001
Re: K222276
Trade/Device Name: CONDUIT™ Cages and FIBERGRAFT™ BG Putty Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX, MQV Dated: July 29, 2022 Received: July 29, 2022
Dear Justin 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. 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/cfdocs/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.
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
1
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 (OS) 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 mediation-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,
For
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K22276
Device Name
CONDUIT™ Cervical Cage
Indications for Use (Describe)
The CONDUIT™ Cervical Cages with a microscopic roughened surface and micro and nano-scale features are intervertebral body fusion devices intended for use for anterior cervical in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiculopathy, myelopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - Tl. The CONDUIT™ Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. CONDUIT™ Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or cortiocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion 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
3
Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use
510(k) Number (if known) K222276
Device Name CONDUITTM ALIF Cage
Indications for Use (Describe)
The CONDUIT™ ALIF Cages with a microscopic roughened surface and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment with the devices.
| 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
4
Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use
510(k) Number (if known) K222276
Device Name CONDUITTM TLIF Cage
Indications for Use (Describe)
The CONDUIT™ TLIF Cages with a microscopic roughened surface and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by Fusion to facilitate fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
| 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
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K22276
Device Name
CONDUITTM LLIF Cage
Indications for Use (Describe)
The CONDUIT™ LLF Cages with a microscopic roughened surface and micro and nano-scale features is indicated for interverebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S I. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade 1 soondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and or allogeneic bone graft comprised of carticocancellous bone graft, or a bone void filler as cleared by PDA for use in intervertebral body fusion to facilitate fusion. CONDUIT™ LLIF Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
| 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
6
Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use
510(k) Number (if known) K22276
Device Name
CONDUIT™ T/PLIF Cage
Indications for Use (Describe)
The CONDUIT™ TPLIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogeneic bone graft comprised of cancellous, and or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with desence (DD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients of nonoperative treatment prior to treatment with the devices.
| 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
7
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K22276
Device Name
FIBERGRAFT™ BG Putty
Indications for Use (Describe)
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT™ BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
FIBERGRAFT™ BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
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
8
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K22276
Device Name FIBERGRAFT™ BG Putty GPS
Indications for Use (Describe)
FIBERGRAFTM BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures. FIBERGRAFTM BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
FIBERGRAFT™ BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.
| 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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K22276
Device Name FIBERGRAFT™BG Putty GPS Cannula
Indications for Use (Describe) The GPS Cannula is intended for use only with FIBERGRAFT™BG Putty GPS and no other products.
| 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.
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510(k) SUMMARY
| A. | Submitter Information |
|---|---|
| Manufacturer: | Medos International SARL |
| Chemin-Blanc 38 | |
| 2400 Le Locle, Switzerland | |
| Submitter: | DePuy Synthes Spine |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| Contact Person: | Mr. Justin Eggleton |
| Vice President, Spine Regulatory Affairs | |
| MCRA LLC | |
| jeggleton@mcra.com | |
| Alternate Contact: | Philip Desjardins |
| Vice President, Global Regulatory Affairs | |
| DePuy Synthes Spine | |
| 325 Paramount Drive | |
| Raynham, MA 02767 | |
| pdesjard@its.jnj.com |
- September 28, 2022 B. Date Prepared
C. Device Name - CONDUIT™ Cages
| Trade/Proprietary Name: | CONDUIT™ Cages |
|---|---|
| Common/Usual Name: | Intervertebral body fusion device |
| Regulatory Class: | Class II per 21 CFR §888.3080 |
| Review Panel: | Orthopedic |
| Product Codes: | ODP, MAX |
Device Name - FIBERGRAFT™ BG Putty D.
| Trade/Proprietary Name: | FIBERGRAFT™ BG Putty |
|---|---|
| Common/Usual Name: | Resorbable calcium salt bone void filler device |
| Regulatory Class: | Class II per 21 CFR §888.3045 |
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Review Panel: Orthopedic
Product Codes: MOV
E. Predicate Device Names
Primary Predicate: DePuy Synthes Spine, K201605, EIT Cellular Cervical Cage, EIT Cellular ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage
Additional Predicate: Nuvasive Inc., K203714, NuVasive Thoracolumbar Interbody Systems and NuVasive Attrax Putty
Additional Predicate: Prosidyan Inc., K170306, FIBERGRAFT™ BG Putty Bone Graft Substitute
F. Device Description
The CONDUIT™ Technology platform is a comprehensive portfolio of 3D-printed porous titanium interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1). Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Lateral (LLIF), Anterior (ALIF) and Transforaminal/Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles. The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).
The CONDUIT™ Cages are made from Ti-6A1-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous, or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion.
The 3D Printed CONDUIT™ Cages have a microscopic roughened surface with micro and nanoscale features. The micro and nano features are on all surfaces of the cage, including the superior, inferior, and peripheral surfaces, as well as each member of the internal cell structure.
The FIBERGRAFT™ BG Putty is an osteoconductive, resorbable, biocompatible bone graft substitute to be gently packed into defect sites and to be used as non-structural scaffolds. The FIBERGRAFT™ BG putty is made from 45S5 bioactive glass, where the bioactive glass components are mixed with an absorbable/polymeric carrier to form a cohesive material.
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The purpose of this submission is to expand the indications for the of CONDUIT™ Cages to include its use with FIBERGRAFT™ BG Putty. Additionally, the indications for the ALIF, TLIF, and T/PLIF cages are being expanded to include the use of allogeneic bone graft comprised of cancellous, and/or corticocancellous bonegraft.
G. Indications for Use
CONDUIT™ Cervical Cage
The CONDUIT™ Cervical Cages with a microscopic roughened surface and micro and nanoscale features are intervertebral body fusion devices intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The CONDUIT™ Cervical Cages are also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. CONDUIT™ Cervical Cages are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
CONDUIT™ ALIF Cage
The CONDUIT™ ALIF Cages with a microscopic roughened surface and micro and nano-scale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease 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 I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
CONDUIT™ TLIF Cage
The CONDUIT™ TLIF Cages with a microscopic roughened surface and micro and nanoscale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and
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radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
CONDUIT™ LLIF Cage
The CONDUIT™ LLIF Cages with a microscopic roughened surface and micro and nano- scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. CONDUIT™ LLIF Cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
CONDUIT™ T/PLIF Cage
The CONDUIT™ T/PLIF Cages with a microscopic roughened surface and micro and nanoscale features in combination with supplemental fixation are indicated for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
FIBERGRAFT™ BG Putty
FIBERGRAFT™ BG Putty - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Putty must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT BG Putty must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
FIBERGRAFT BG Putty is not indicated for use in load-bearing applications; therefore, standard
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internal or external stabilization techniques must be followed to obtain rigid stabilization.
FIBERGRAFT™ BG Putty GPS
FIBERGRAFTIM BG Putty GPS - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Putty GPS is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, intervertebral disc space, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Putty GPS must be used with autograft in the posterolateral spine. When used in intervertebral body fusion procedures, FIBERGRAFT BG Putty GPS must be used on its own with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
FIBERGRAFT BG Putty GPS is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be obtain rigid stabilization.
FIBERGRAFT™ GPS Cannula
The GPS Cannula is intended for use only with FIBERGRAFT™ BG Putty GPS and no other products.
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H. Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use
The purpose of this Traditional 510(k) is to expand the indications for of the CONDUIT™ Cages to include its used with FIBERGRAFT™ BG Putty. Additionally, the indications for the ALIF, TLIF, and T/PLIF cages are being expanded to include the use of allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft. The subject device is substantially equivalent to the predicate devices with respect to indications, design, function, and performance. There are no differences in technological characteristics that will raise new concerns of safety or performance.
I. Materials
The CONDUIT™ Cervical and Lumbar Cages are all constructed from Standard Specification for Additive Manufacturing Titanium-6 Vanadium ELI with Extra Low Interstitials components using full-melt powder bed fusion in conformance with ASTM F3001. The BG Putty is composed of the same bioactive glass material with the same bioactive glass chemical composition and the same type and duration of patient contact as the predicate. The materials and manufacturing process for the CONDUIT™ subject devices are identical to that of the predicate device. Similarly, the materials and composition of the BG Putty device are identical to that of the predicate device and the manufacturing process remains substantially the same as that of the predicate. It is important to note that the manufacturing location of BG Putty was moved from Steris to Prosidyan (now DePuy Synthes), however the process has not changed.
J. Performance Data
The performance of the CONDUIT™ Cervical and Lumbar Cages and the FIBERGRAFTTM BG Putty have been assessed individually within their respective submissions (K201605, and K170306). Clinical data has been utilized to demonstrate the performance and safety of the expanded indications for use, which includes the use of the CONDUIT™ Cages with FIBERGRAFT™ BGPutty. The clinical data includes radiographic and clinical outcomes from a retrospective study and two investigator-initiated studies. The data provided includes 178 subjects and was collected from multiple sites across the United States (CA, TX, FL) to capture a variety of populations with diverse gender and racial/ethnic backgrounds that is representative of the intended users of the subject devices. The results of the data support the performance of the subject devices in intervertebral body fusion based on fusion and adverse event rates. Additional rationales were provided to justify the expanded indications based upon the clinical data results.
K. Conclusion
Based on the body of data presented throughout the submission, it has been determined that the subject devices are substantially equivalent to the predicate devices with respect to indications for use, technological characteristics, and performance data.