(143 days)
ABTross ALIF Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. ABTross ALIF Expandable Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>=20° lordosis) must be used with at least anterior supplemental fixation.
The ABTross ALIF Expandable Cage System is interbody fusion devices. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And cages are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies. The cage can be expanded in height using the system instrument after being inserted in the unexpanded state. The cages have serrations on the superior endplate and inferior endplate surfaces area to contact vertebrae bone endplate. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g., posterior pedicle screw and rod systems, anterior or lateral plate systems, and anterior screw and rod systems). All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances.
The provided text describes the regulatory filing for the ABTross ALIF Expandable Cage System, a medical device for spinal fusion. It details the device's indications for use, materials, and comparative analysis with predicate devices. However, the document does not contain the specific information requested regarding acceptance criteria for a device performance, the study that proves it meets those criteria, or details related to AI/MRMC studies.
The document focuses on demonstrating substantial equivalence to existing devices cleared by the FDA, primarily through bench testing of mechanical properties. It does not present clinical study data or performance metrics in the format of acceptance criteria.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or AI/MRMC study results, as this information is not present in the provided text.
The text does mention:
- Performance Data: "Performance testing was performed to demonstrate that the subject ABTross ALIF Expandable Cage System is substantially equivalent to other predicate devices."
- Tests Conducted: Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, static expulsion test (ASTM draft F-04.25.02.02), and static subsidence test (ASTM F 2267-04).
- Result of Tests: "Bench testing to evaluate the mechanical properties of the ABTross ALIF Expandable Cage System showed a higher or similar mechanical value than predicate marketed devices."
- Ground Truth Type: Not explicitly stated, but the "higher or similar mechanical value" suggests that the "ground truth" for the mechanical tests would be the established acceptable mechanical properties or performance of the predicate devices according to the ASTM standards.
- Training Set Sample Size/Ground Truth: This information is not applicable and hence not provided as the evaluation is based on mechanical bench testing against predicate performance, not a machine learning model.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 3, 2022
Aegis Spine, Inc. Kihyang Kim Regulatory Affairs 9781 S. Meridian Blvd, Ste 300 Englewood, Colorado 80112
Re: K221719
Trade/Device Name: ABTross ALIF Expandable Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 3, 2022 Received: October 5, 2022
Dear Kihyang Kim:
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
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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,
for 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
Indications for Use
510(k) Number (if known) K221719
Device Name ABTross ALIF Expandable Cage System
Indications for Use (Describe)
ABTross ALIF Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. ABTross ALIF Expandable Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
| 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) |
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K221719 - 510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1. SUBMITTER
| Submitter's Name: | Aegis Spine, INC. |
|---|---|
| Submitter's Address: | 9781 S. Meridian Blvd, Ste 300Englewood, CO 80112 |
| Submitter's Telephone: | +1.303.741.4123 |
| Contact Person: | Kihyang Kim+1.303.741.4123khkim@aegisspine.com/khkim3747@gmail.com |
2. DEVICE NAME
| Trade or Proprietary Name | ABTross ALIF Expandable Cage System |
|---|---|
| Common or Usual Name | Intervertebral Body Fusion Device, Intervertebral cage, Spacer |
| Regulation class / Number | ClassII, CFR 888.3080 |
| Regulation Name | Intervertebral Body Fusion Device |
| Product Code | MAX |
| Classification Panel | Spinal Devices (DHT6B) |
PREDICATE DEVICE 3.
The subject ABTross ALIF Expandable Cage System is substantially equivalent to the following devices:
Primary Predicate Device
-
MAGNIFY TM Spacer System(K142498) .
Additional Predicate Devices -
XYPAN Expandable Lumbar Cage (XL, XTP) System(K203531)
-
Xenco Medical Lumbar Interbody System(K143158) .
-
Vu a POD Intervertebral Body Fusion Device (K080822/K121211/K173606) .
DESCRIPTION OF THE DEVICE 4.
The ABTross ALIF Expandable Cage System is interbody fusion devices. This cage system is made of Titanium 6AL-4V Alloy (ASTM F136). And cages are offered in a variety of widths, lengths, heights and lordotic angles designed to adapt to a variety of patient anatomies.
The cage can be expanded in height using the system instrument after being inserted in the unexpanded state. The cages have serrations on the superior endplate and inferior endplate surfaces area to contact vertebrae bone endplate. The device system is designed for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbrosacral spine (e.g., posterior pedicle screw and rod systems, anterior or lateral plate systems, and anterior screw and rod systems). All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances.
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ડ. INDICATION FOR USE
ABTross ALIF Expandable Cage System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with bone graft hone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) to facilitate fusion. ABTross ALIF Expandable Cage System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should have at least six months of nonoperative treatment prior to treatment with a lumbar intervertebral fusion device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
PERFORMANCE DATA 6.
Performance testing was performed to demonstrate that the subject ABTross ALIF Expandable Cage System is substantially equivalent to other predicate devices.
Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, was presented to demonstrate the substantial equivalency of the ABTross ALIF Expandable Cage System to the predicate devices.
- Static Axial Compression Test ASTM F 2077 -18 "
- י Static Compression-Shear Test - ASTM F 2077 -18
- . Static Expulsion Test - ASTM draft F-04.25.02.02
- Static Subsidence Test ASTM F 2267 04 (Reapproved 2018) .
- . Dynamic Axial Compression Test- ASTM F 2077 -18
- . Dynamic Compression-Shear Test - ASTM F 2077 -18
Bench testing to evaluate the mechanical properties of the ABTross ALIF Expandable Cage System showed a higher or similar mechanical value than predicate marketed devices.
7. MATERIAL
The ABTross ALIF Expandable Cage System is manufactured from Ti-6Al-4V ELI titanium alloy (ASTM
F136). This this is the same material used in the predicate devices.
COMPARISON OF TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 8.
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:
- . Instruction for use
- . Design
- . Expanding Mechanism
- . Material
- . Approach
- Sterilization & Method
The following technological similarities and differences exist between the subject and predicate devices:
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| INDICATION FOR USE | ||
|---|---|---|
| This Subject ABTross ALIFExpandable Cage System /MAX | withNot indicated for standalone use and must be used with supplemental fixation.Hyper lordotic degree ( $≥20°$ lordosis) must be used with at least anterior supplementalfixation. | |
| Predicate Devices | Similarities | Differences |
| MAGNIFY TM SpacersMAGNIFY™ S SpacersK142498 / MAX, OVD | Below both indications can be usedMAGNIFY TM Spacers is not indicatedfor stand-alone use and must be usedwith supplemental fixation. | MAGNIFY™ S Spacers is stand-alonedevices. |
| XYPAN ExpandableLumbar Cage (XL, XTP)System K203531 / MAX | Not indicated for standalone use andmust be used with supplementalfixation. | |
| Xenco Medical LumbarInterbody System K143158/MAX | Not indicated for standalone use andmust be used with supplementalfixation. | |
| Vu a POD IntervertebralBody Fusion DeviceK080822/K121211/K173606/MAX, OVD | Below both indications can be usedNot indicated for standalone use andmust be used with supplementalfixation (without use SpinePlate andbone screws)Hyper lordotic degree ( $≥20°$ lordosis)must be used with at least anteriorsupplemental fixation. | When used with provided SpinePlateand bone screws, is a stand-alonedevice. |
| AnyPlus® Peek CageK100516/K111354 /MAX | Not indicated for standalone use andmust be used with supplementalfixation. |
| DESIGN | ||
|---|---|---|
| This Subject ABTross ALIFExpandable Cage System | • Lordotic rectangular cylindrical shape and has an open space inside for bone graft forAnterior approach• Lordotic Min. / Max. angle: 8° ~ 30°• Depth / width (mm) / Height :24x32 / 29x38 / 6 ~19 | |
| Predicate Devices | Similarities | Differences |
| MAGNIFY TM SpacersMAGNIFY™ S SpacersK142498 | • Lordotic rectangular shape and has anopen space inside for bone graft forAnterior approach• Depth / width / Height: similar | • Provided screws for stand-aloneindication• Lordotic Min. /Max. angle: 8° ~ 15° |
| XYPAN ExpandableLumbar Cage (XL, XTP)System K203531 | • Lordotic rectangular cylindrical shape andhas an open space inside for bone graft forlateral approach.• Depth / width / height: similar / bigger | • Curved (banana shape) shape and hasan open space inside for bone graftfor Anterior to Psoas approach.• Lordotic Min. /Max. angle: 0° ~ 15° |
| Xenco Medical LumbarInterbody SystemK143158 | • Rectangular cylindrical shape and has anopen space inside for bone graft forAnterior approach• Hyper Lordotic angle: 20° ~ 30° | - |
| Vu a POD IntervertebralBody Fusion DeviceK080822/K121211/K173606 | • Rectangular cylindrical shape and has anopen space inside for bone graft.• Depth / width / Height: similar | • Provided SpinePlate and bone screwsfor stand-alone indication• Lordotic Min. /Max.angle: 8° ~ 15° |
| AnyPlus® Peek Cage(ALIF) K100516/K111354 | • Rectangular cylindrical shape and has anopen space inside for bone graft.• Depth / width / Height: similar | • Lordotic Min. /Max.angle: 0° ~ 11° |
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| EXPANDING MECHANISM | ||
|---|---|---|
| This Subject ABTross ALIF ExpandableCage System | · Expandable Devices - Height adjusting in mm: 6 | |
| Predicate Devices | Similarities | Differences |
| MAGNIFY TM SpacersMAGNIFY™ S Spacers/K142498 | · Expandable Devices - Heightadjusting in mm 8 | · When rotate adjusting driverclockwise, the side pins on bothsides are pulled forward, pushingthe upper and lower end plates upand down. |
| XYPAN Expandable Lumbar Cage (XL,XTP) System K203531 | · Expandable Devices- Heightadjusting mm 6 | - |
| Xenco Medical Lumbar InterbodySystem K143158 | - | Non-Expandable Devices |
| Vu a POD Intervertebral Body FusionDevice K080822/K121211/K173606 | - | Non-Expandable Devices |
| AnyPlus® Peek Cage 100516/K111354 | - | Non-Expandable Devices |
| MATERIAL | ||
|---|---|---|
| This Subject ABTross ALIF ExpandableCage System | Ti-6Al-4V ELI titanium alloy (ASTM F136) | |
| Predicate Devices | Similarities | Differences |
| MAGNIFY TM Spacers | Ti-6Al-4V ELI titanium alloy(ASTM F136) | - |
| MAGNIFY TM S Spacers/K142498 | ||
| XYPAN Expandable Lumbar Cage (XL,XTP) System K203531 | Ti-6Al-4V ELI titanium alloy(ASTM F136) | - |
| Xenco Medical Lumbar InterbodySystem K143158 | - | PEEK (ASTM F 2026) withTantalum markers (ASTM F560) |
| Vu a POD Intervertebral Body FusionDevice K080822/K121211/K173606 | Ti-6Al-4V ELI titanium alloy(ASTM F136)- Spineplate andscrews | PEEK (ASTM F 2026) withTantalum markers (ASTM F560)-cage |
| AnyPlus® Peek Cage K100516/K111354 | - | PEEK (ASTM F 2026) with Ti-6Al-4V ELI titanium alloy makers(ASTM F136) |
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| APPROACH | ||
|---|---|---|
| This Subject ABTross ALIF ExpandableCage System | • Anterior Approach (ALIF) | |
| Predicate Devices | Similarities | Differences(Provided other approach cages) |
| MAGNIFY TM SpacersMAGNIFY™ S Spacers/K142498 | • Anterior Approach (ALIF) | |
| XYPAN Expandable Lumbar Cage (XL,XTP) System K203531 | - | • lateral approach (LLIF)• Anterior to Psoas approach(ATP). |
| Xenco Medical Lumbar InterbodySystem K143158 | • Anterior Approach (ALIF) | - |
| Vu a POD Intervertebral Body FusionDevice K080822/K121211/K173606 | • Anterior Approach (ALIF) | - |
| AnyPlus® Peek Cage K100516/K111354 | • Anterior Approach (ALIF) | • Posterior Approach (PLIF)• Transforaminal Approach (TILF) |
| STERILIZATION & METHOD | Similarities | Differences |
|---|---|---|
| This Subject ABTross ALIF ExpandableCage System | · Sterile Cage: Gamma Radiation· Intended for SINGLE USE ONLY | |
| Predicate Devices | ||
| MAGNIFY TM Spacers | · Sterile Cage: Gamma Radiation· Intended for SINGLE USE ONLY | - |
| MAGNIFY™ S Spacers K142498 | · Sterile Cage: Gamma Radiation· Intended for SINGLE USE ONLY | - |
| XYPAN Expandable Lumbar Cage (XL,XTP) System K203531 | · Sterile Cage: Gamma Radiation· Intended for SINGLE USE ONLY | · Non-Sterile |
| Xenco Medical Lumbar InterbodySystem K143158 | · Sterile Cage: Gamma Radiation· Intended for SINGLE USE ONLY | - |
| Vu a POD Intervertebral Body FusionDevice K080822/K121211/K173606 | - | · Non-Sterile |
| AnyPlus® Peek Cage K100516/K111354 | - | · Non-Sterile |
9. SUBSTANTIAL EQUIVALENCE AND CONCLUSION
The subject ABTross ALIF Expandable Cage System have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject
device to the predicate devices. The overall Data lead to the conclusion that the ABTross ALIF Expandable Cage System is substantially equivalent to the predicate devices.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.