(141 days)
Not Found
No
The document describes a physical implantable device made of PEEK and titanium for spinal fusion. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an "Intervertebral Body/VBR Fusion System" used for various spinal fusion procedures, including treating degenerative disc disease, replacing resected vertebral bodies due to tumors or trauma, and treating spinal fractures. These applications directly address medical conditions and injuries, aiming to restore proper anatomical function, alleviate pain, and improve the patient's health, thus qualifying it as a therapeutic device.
No
Explanation: The device is an intervertebral body fusion system, intended for spinal fusion procedures to replace a vertebral body. It is a surgical implant, not a tool for diagnosis.
No
The device description clearly states that the Lanx Fusion System is made of physical materials (PEEK and Titanium alloy) and is an implantable device for spinal fusion. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Lanx Fusion System is an implantable device used for spinal fusion and vertebral body replacement. It is surgically placed within the body to provide structural support and facilitate bone growth.
- Lack of Mention of Samples or Testing: The text does not mention any use of samples from the body or any diagnostic testing being performed by the device.
Therefore, the Lanx Fusion System falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.
- When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when used with the integrated fixation screws, do not require use of supplemental fixation.
- When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX, MQP, ODP
Device Description
This submission is intended to seek clearance for a product line extension to the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System"). The product line extension includes the Lanx SA standalone implant models with titanium components for additional fixation.
All devices in the Lanx Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Fusion System has a hollowed out area to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.
The additional models added to the product line have the same or similar intended use and indications, principles of operation and technological characteristics as the current Lanx Fusion System. The addition of titanium components for additional fixation, and indications for standalone lumbar interbody use, do not raise any new questions of safety or effectiveness. Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Spinal, cervical (C2-C3 disc to C7-T1 disc), lumbar (L2-S1), thoracolumbar spine (T1 to L5)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
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)
Performance testing for comparison of mechanical performance included tests per ASTM F2077 (static and dynamic compression, static torsion) and ASTM F2267 (subsidence). In all instances, the Lanx Fusion System met acceptance criteria and functioned as intended.
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.
Lanx Fusion System (K083815), Synthes SynFix-LR (K072253)
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
FEB 1 0 2011
510(k) SUMMARY
Lanx, Inc's Intervertebral Body/VBR Fusion System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021
Contact Person: Alan Burkholder Phone: 303-501-8411 Facsimile: 303-443-7501 Date Prepared: September 21, 2010
Name of Device and Name/Address of Sponsor
Lanx Fusion System Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021
Common or Usual Name Vertebral Body Replacement/Intervertebral Body Fusion Device
Classification Name
21 CFR 888.3080, Orthosis, spinal intervertebral fusion 21 CFR § 888.3060, Spinal intervertebral body fixation orthosis
Predicate Devices
Lanx Fusion System (K083815) Synthes SynFix-LR (K072253)
1
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when used with the integrated fixation screws, do not require use of supplemental fixation.
When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
Technological Characteristics
This submission is intended to seek clearance for a product line extension to the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System"). The product line extension includes the Lanx SA standalone implant models with titanium components for additional fixation.
All devices in the Lanx Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Fusion System has a hollowed out area to accommodate bone
2
graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.
The additional models added to the product line have the same or similar intended use and indications, principles of operation and technological characteristics as the current Lanx Fusion The addition of titanium components for additional fixation, and indications for System. standalone lumbar interbody use, do not raise any new questions of safety or effectiveness. Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices.
Performance Data
Performance testing for comparison of mechanical performance included tests per ASTM F2077 (static and dynamic compression, static torsion) and ASTM F2267 (subsidence). In all instances, the Lanx Fusion System met acceptance criteria and functioned as intended.
Substantial Equivalence
The standalone implants included in the product line extension have the same or similar intended uses, indications, technological characteristics, and principles of operation as the previously cleared Lanx Intervertebral Body Fusion Device (K083815). Performance data demonstrate that these additions to the Lanx Fusion System do not raise new issues of safety or effectiveness; hence it is as safe and effective as the predicate devices. Thus, the modified device is substantially equivalent.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lanx, Inc. % Mr. Alan Burkholder 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021
SEP
Re: K102738 Trade/Device Name: Lanx Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX, MQP, ODP Dated: February 2, 2011 Received: February 3, 2011
Dear Mr. Burkholder:
This letter corrects our substantially equivalent letter of February 10, 2011.
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 (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.
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 requirements, including, but not
4
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/ReportaProblem/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 A. Mulkeran
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K102738
Device Name: Lanx Fusion System
Indications for Use:
When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degeneralive disc disease ("DD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degeneralive disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when used with the integrated fixation screws, do not require use of supplemental fixation.
When used as vertebrai body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to LS) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., TI- L5) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the used withsupplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
| Prescription Use | X |
|---|---|
| (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Surgical, Orthopedic, and Restorative Devices |
| 510(k) Number | K102738 |
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| Page | 1 of 1 |
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