K201939 · Printerprezz · MAX · Oct 8, 2020 · Orthopedic
Device Facts
Record ID
K201939
Device Name
GAIA Lumbar Interbody Fusion Device (LIFD) Family
Applicant
Printerprezz
Product Code
MAX · Orthopedic
Decision Date
Oct 8, 2020
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The ASTRAEUS anterior lumbar interbody fusion device is a member of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous bone graft. GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ASTRAEUS ALIF cage is to be implanted via an anterior approach. The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The PROMETHEUS PLIF cage is to be implanted via a posterior approach. The THEMIS Transforaminal posterior lumbar is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with disc disease (DDD) at one or two contiquous 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. GAIA devices, including the THEMS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.
Device Story
GAIA LIFD family (ASTRAEUS ALIF, PROMETHEUS PLIF, THEMIS TPLIF) provides structural stability for spinal fusion; implanted via anterior, posterior, or transforaminal approaches; used with autogenous/allograft bone graft; requires supplemental spinal fixation. Additively manufactured titanium alloy cages feature axial graft windows and high-friction surface protrusions to grip vertebral endplates; resist expulsion/migration. Used by surgeons in clinical settings to treat DDD and degenerative scoliosis; provides structural support to facilitate arthrodesis.
Clinical Evidence
Bench testing only. Performed static and dynamic axial compression, static and dynamic compression shear (ASTM F2077-18), and subsidence testing (ASTM F2267-04 (2018)). No clinical data provided.
Technological Characteristics
Additively manufactured titanium alloy (Ti-6Al-4V) per ASTM F3001. Features axial graft windows and high-friction surface protrusions. Available in various sizes (width, length, height, lordotic angle).
Indications for Use
Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis, and as an adjunct for degenerative scoliosis. Requires 6 months of failed non-operative treatment. Must be used with supplemental spinal fixation.
Regulatory Classification
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.
Special Controls
*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.
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October 8, 2020
PrinterPrezz % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K201939
Trade/Device Name: GAIA Lumbar Interbody Fusion Device (LIFD) Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 10, 2020 Received: July 13, 2020
Dear Mr. Wright:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
## Indications for Use
#### 510(k) Number (if known)
K201939 Device Name
#### GAIA Lumbar Interbody Fusion Device (LIFD) Family
#### Indications for Use (Describe)
The ASTRAEUS anterior lumbar interbody fusion device is a member of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous bone graft.
GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ASTRAEUS ALIF cage is to be implanted via an anterior approach.
The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The PROMETHEUS PLIF cage is to be implanted via a posterior approach.
The THEMIS Transforaminal posterior lumbar is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) in skeletally mature patients with disc disease (DDD) at one or two contiquous 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 at the involved level(s). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the THEMS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.
Type of Use (Select one or both, as applicable)
□ Over-The-Counter Use (21 CFR 801 Subpart C) ∑ Prescription Use (Part 21 CFR 801 Subpart D)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
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# 5.510(K) SUMMARY
| Submitter's Name: | PrinterPrezz |
|----------------------------|---------------------------------------------------------------------------------------|
| Submitter's Address: | 4110 Clipper Ct.<br>Fremont, CA 94538 |
| Submitter's Telephone: | 510-225-8412 |
| Contact Person: | Nathan Wright MS<br>Empirical Consulting<br>719-351-0248<br>nwright@empiricaltech.com |
| Date Summary was Prepared: | 10-Jul-2020 |
| Trade or Proprietary Name: | GAIA Lumbar Interbody Fusion Device (LIFD) Family |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedic Devices |
#### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The GAIA Lumbar Interbody Fusion Device (LIFD) Family consists of the ASTRAEUS ALIF, the PROMETHEUS PLIF, and the THEMIS TPLIF.
The ASTRAEUS anterior lumbar interbody fusion (ALIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The ASTRAEUS ALIF devices are to be implanted via an anterior approach.
The PROMETHEUS posterior lumbar interbody fusion (PLIF) implants are interbody fusion devices intended for use as an aid in spinal fixation and provide structural stability in skeletally mature patients. The PROMETHEUS PLIF devices are to be implanted via a posterior approach.
The THEMIS transforaminal posterior lumbar interbody fusion (TPLIF) implants are interbody fusion devices intended for use an aid in spinal fixation and provided structural stability in skeletally mature patients. THE THEMIS TPLIF devices are to be implanted via a transforaminal or posterior approach.
The GAIA Lumbar Interbody Fusion Device (LIFD) Family implants are manufactured additively from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are offered in a variety of standard sizes (width, length, height, lordotic angle) designed to adapt to many different patient anatomy. Each interbody device has an axial graft window to allow bone grafting material of autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to be placed inside the interbody. Various interbody window lattices are provided to adapt to various bone graft placement methods. High friction surfaces with protrusions on superior and inferior of the interbody fusion device grip the end plates of adjacent vertebrae to resist
PrinterPrezz GAIA Lumbar Interbody Fusion Device (LIFD) Family
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expulsion or other unintended migration of the implants provide an alternative to autogenous bone graft blocks and assist to reduce complications related to bone graft.
## INDICATIONS FOR USE
The ASTRAEUS anterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the ASTRAEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Additionally, the ASTRAEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The ASTRAEUS ALIF cage is to be implanted via an anterior approach.
The PROMETHEUS Posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the PROMETHEUS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Additionally, the PROMETHEUS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The PROMETHEUS PLIF cage is to be implanted via a posterior approach.
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The THEMIS Transforaminal posterior lumbar interbody fusion device is a member of the GAIA family of interbody fusion devices intended for interbody fusion procedures (arthrodesis) 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). This device is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
GAIA devices, including the THEMIS system, are to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Additionally, the THEMIS cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The THEMIS TPLIF cage is to be implanted via a transforaminal or posterior approach.
#### TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- o Indications for Use
- O Materials of manufacture
- Structural support mechanism 0
- Sizes
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|-----------------|-----------------------------------------|------------------------------|----------------|
| K170676 | HD Lumbar Interbody System | HD LifeSciences LLC | Primary |
| K172816 | TiGer Shark™ System | Choice Spine, LP | Additional |
| K162496 | Foundation F3 Interbody | CoreLink, LLC | Additional |
| K143258 | PLIF STS, TLIF STS, and OLIF<br>STS | 4WEB, Inc. | Additional |
| K180556 | Foundation 3D Anterior Lumbar<br>System | CoreLink, LLC | Additional |
| K190483 | SPIRA Open Matrix ALIF and<br>LLIF | Camber Spine<br>Technologies | Additional |
| K111354/K131612 | AnyPlus® PEEK Lumbar Fusion<br>Cage | GS Medical Co, Ltd. | Additional |
#### Table 5-1 Predicate Devices
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## PERFORMANCE DATA
The GAIA Lumbar Interbody Fusion Device (LIFD) Family has been tested in the following test modes:
- o Static and dynamic axial compression per ASTM F2077-18
- Static and dynamic compression shear per ASTM F2077-18 0
- o Subsidence per ASTM F2267-04 (2018)
The results of this non-clinical testing show that the strength of the GAIA Lumbar Interbody Fusion Device (LIFD) Family is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
#### CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the GAIA Lumbar Interbody Fusion Device (LIFD) Family is substantially equivalent to the predicate device.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
