(89 days)
Not Found
No
The summary describes a mechanical interbody fusion device and surgical instruments, with no mention of AI or ML capabilities.
Yes
The device is indicated for spinal fusion procedures to treat degenerative disc disease, and for vertebral body replacement due to tumor or trauma, all of which address medical conditions to restore function and mitigate symptoms.
No
The device is described as an intervertebral body fusion device and a vertebral body replacement device, intended for spinal fusion procedures and replacing vertebral bodies. Its purpose is therapeutic (fusion and replacement), not diagnostic (identifying or characterizing a disease).
No
The device description explicitly states that the system is comprised of "interbody implants, curved access instruments and specialized disc preparatory instruments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for spinal fusion and vertebral body replacement. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical implants and surgical instruments used for accessing and preparing the spine. This aligns with a surgical device.
- No mention of in vitro testing: There is no indication that this device is used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is directly implanted into the body for structural support and fusion.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the Guided Lateral Interbody Fusion (GLIF) System is indicated for spinal 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 patients should have had six months of non-operative treatment. The GLIF System is to be used with a supplemental fixation system and autogenous bone graft.
When used as a vertebral body replacement device, the Guided Lateral Interbody Fusion (GLIF) system is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The GLIF System is intended for use with supplemental spinal fixation system. Specifically the GLIF System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the GLIF System is intended for use with allograft.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
The Guided Lateral Interbody Fusion (GLIF) System will be comprised of interbody implants, curved access instruments and specialized disc preparatory instruments. The Guided Lateral Interbody Fusion (GLIF) System provides a lateral approach to the spine from a posterior angle while the patient is in the prone position. The lateral access technique allows a larger cage to be implanted similar to an anterior lumbar interbody fusion sized cage and patient is already in the prone position which eliminates the need to break the sterility field and flip the patient for supplemental fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (L2-S1; T1-L5)
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 test results demonstrate that the mechanical performance of the GLIF System is substantially equivalent to the predicate device.
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.
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
Guided Lateral Interbody Fusion (GLIF) System 510(k) SUMMARY February 2009
MAY 19 2009
| Company: | Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008 USA
Direct: (760) 494-6771
Fax: (760) 431-0289 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Stanners, Regulatory Affairs Specialist II |
| Trade/Proprietary Name: | Guided Lateral Interbody Fusion (GLIF) System |
| Common Name: | Intervertebral Body Fusion Device
Vertebral Body Replacement Device |
| Classification Name: | Intervertebral Body Fusion Device
Spinal Intervertebral Body Fixation Orthosis |
| Classification Number(s)/Product Code(s): | 21 CFR 888.3080 (MAX)
21 CFR 888.3060 (MQP) |
| Product Description: | |
The Guided Lateral Interbody Fusion (GLIF) System will be comprised of interbody implants, curved access instruments and specialized disc preparatory instruments. The Guided Lateral Interbody Fusion (GLIF) System provides a lateral approach to the spine from a posterior angle while the patient is in the prone position. The lateral access technique allows a larger cage to be implanted similar to an anterior lumbar interbody fusion sized cage and patient is already in the prone position which eliminates the need to break the sterility field and flip the patient for supplemental fixation.
Indications for Use:
When used as an intervertebral body fusion device, the Guided Lateral Interbody Fusion (GLIF) System is indicated for spinal 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 patients should have had six months of non-operative treatment. The GLIF System is to be used with a supplemental fixation system and autogenous bone graft.
When used as a vertebral body replacement device, the Guided Lateral Interbody Fusion (GLIF) system is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or
1
unstable vertebral body due to tumor or trauma (i.e. fracture). The GLIF System is intended for use with supplemental spinal fixation system. Specifically the GLIF System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the GLIF System is intended for use with allograft.
Substantial Equivalence:
Data was provided which demonstrated the Guided Lateral Interbody Fusion (GLIF) System to be substantially equivalent to the Novel Spinal Spacer System (K080699) and the Nuvasive CoRoent (K071795). The substantial equivalence is based upon equivalence in indications for use, design, material and function.
Performance Data:
The test results demonstrate that the mechanical performance of the GLIF System is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
MAY 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alphatec Spine, Inc. % Ms. Mary Stanners Regulatory Affairs Specialist II 5818 El Camino Real Carlsbad, California 92008
Re: K090425
Trade/Device Name: Guided Lateral Interbody Fusion (GLIF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MQP Dated: February 17, 2009 Received: February 19, 2009
Dear Ms. Stanners:
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 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 (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,
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Page 2- Ms. Mary Stanners
Enclosure
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (210) 210 0151cation" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
P-R
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Number (if known): TBD
Device Name: Guided Lateral Interbody Fusion (GLIF) System
Indications for Use:
When used as an intervertebral body fusion device, the Guided Lateral Interbody Fusion (GLIF) System is indicated for spinal 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 patients should have had six months of non-operative treatment. The GLIF System is to be used with a supplemental fixation system and autogenous bone graft.
When used as a vertebral body replacement device, the Guided Lateral Interbody Fusion (GLIF) system is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The GLIF System is intended for use with supplemental spinal fixation system. Specifically the GLIF System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the GLIF System is intended for use with allograft.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K09043