(750 days)
P950002, K031672, P960025
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "mathematically designed" trusses refer to engineering principles, not AI/ML.
Yes
The device is described as an "Interbody Fusion Device" indicated for fusing the lumbar spine in patients with Degenerative Disc Disease to provide mechanical support and promote biologic fusion, which aligns with the definition of a therapeutic device.
No
The device is described as an implant designed to provide mechanical support to the lumbar spine for fusion, not to diagnose a condition.
No
The device description clearly states it is a titanium implant, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The ALIF Spinal Truss System (STS) Interbody Fusion Device is a surgical implant designed to be placed inside the body to provide mechanical support and facilitate bone fusion in the spine.
- Intended Use: The intended use clearly states it's for treating Degenerative Disc Disease by providing mechanical support and promoting fusion in vivo (within the living body).
The information provided describes a medical device used in surgery, not a device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The ALIF Spinal Truss System (STS) Interbody Fusion Device is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.
The device is available in three basic "footprint" sizes, small, medium and large. These sizes are available in zero degree lordosis and 8 degree lordosis and each of these in 8 heights ranging from 10mm to 17mm in 1mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar spine)
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)
Preclinical testing performed on the 4-Web STS® Interbody Fusion Device included static r receimedi compression shear, static torsion, dynamic axial compression, and dynamic compressive shear mechanical testing per ASTM F2077. Other mechanical tests included subsidence per ASTM F2267-04 and expulsion testing per an industry accepted methodology. Finite Element Analysis to assess mechanical stiffness, quantify stresses and intra-cage pressure and to quantify porosity was also completed. Finally, an animal study in sheep which demonstrated fusion was performed. The outcome of pre-clinical testing performed indicates that the ALIF STS® Interbody Fusion Device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P950002, K031672, P960025
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
510(k) Summary according to 807.92(c)
JAN 18 201
| Date prepared: | January 17, 2011 |
|---|---|
| Contact: | Jessee Hunt, President |
| 4-Web Spine, Inc. | |
| 6629 Whispering Woods Ct. | |
| Plano, TX 75024 | |
| 972-841-6126 | |
| Trade Name: | ALIF Spinal Truss System ® Interbody Fusion Device |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3080 Orthosis, intervertebral fusion |
| Product Codes: | MAX |
| Panel Code: | 87 |
Indications for Use:
The ALIF Spinal Truss System (STS) Interbody Fusion Device is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Device Description:
The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy.
The device is available in three basic "footprint" sizes, small, medium and large. These sizes are available in zero degree lordosis and 8 degree lordosis and each of these in 8 heights ranging from 10mm to 17mm in 1mm increments.
Predicate Device(s):
The ALIF STS® Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The predicate devices include the BAK Interbody Fusion Device (Spine-Tech, P950002), Infix System from Spinal Concepts (K031672) and the Brantigan Lumbar I/F Cage (AcroMed, P960025). (Add Titan Spine?)
Performance Testing:
Preclinical testing performed on the 4-Web STS® Interbody Fusion Device included static r receimedi compression shear, static torsion, dynamic axial compression, and dynamic
1
K083894 page 2 of 2
compressive shear mechanical testing per ASTM F2077. Other mechanical tests included subsidence per ASTM F2267-04 and expulsion testing per an industry accepted methodology. Finite Element Analysis to assess mechanical stiffness, quantify stresses and intra-cage pressure and to quantify porosity was also completed. Finally, an animal study in sheep which demonstrated fusion was performed. The outcome of pre-clinical testing performed indicates that the ALIF STS® Interbody Fusion Device is substantially equivalent to the predicate devices..
2
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem of a stylized bird, which is a common symbol used by HHS.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
4-Web Spine. Inc. % Richard Jansen, Pharm.D. Silver Pine Consulting 13540 Guild Avenue Apple Valley, Minnesota 55124
JAN 1 8 2011
Re: K083894
Trade/Device Name: ALIF Spinal Truss System® Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 22, 2010 Received: December 27, 2010
Dear Dr. Jansen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
3
Page 2 - Richard Jansen, Pharm.D.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
page 1 of
Statement of Indications for Use
510(k) Number (if known): K083894
Indications for Use:
The ALIF Spinal Truss Interbody Fusion Device is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
K083894 510(k) Number_