(98 days)
Not Found
No
The document describes a physical implant device made of PEEK with tantalum markers, intended for spinal fusion and vertebral body replacement. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical testing of the implant.
Yes
The device is described as an intervertebral body fusion device and a vertebral body replacement, intended for spinal fusion procedures and to replace resected vertebral bodies due to tumor or trauma/fracture. These applications within the human body for medical purposes classify it as a therapeutic device.
No
The device is described as an intervertebral body fusion device and vertebral body replacement, which are surgically implanted devices designed for structural support and fusion, not for diagnosing medical conditions. The "Indications for Use" section specifies its role in treatment (spinal fusion, tumor resection, fracture repair), not diagnosis.
No
The device description clearly states the product line includes "implant models" made of PEEK and Tantalum, which are physical materials used in surgical implants, not software.
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 the materials and physical characteristics of a surgical implant. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological specimens, which is the core function of an IVD.
Therefore, the Lanx Fusion System - Lateral is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a lumbar intervertebral body fusion device, the Lanx Fusion System -Lateral ("Lanx Lateral") 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-SI. 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 Lateral is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System.
When used as vertebral body replacement, the Lanx·Fusion System - Lateral ("Lanx Lateral") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Lateral 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 Lateral is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Lateral 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
MAX, MOP
Device Description
This submission is intended to seek clearance for the Lanx Fusion System - Lateral ("Lanx Lateral"). The product line includes the Lanx Lateral implant models which include the addition of new footprints and configurations.
All devices in the Lanx Lateral are made of PEEK (OPTIMA®) per ASTM F2026. The PEEK components include Tantalum markers per ASTM F560. The Lanx Lateral has a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Lateral is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal levels L2-S1, Thoracolumbar spine (from 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 was conducted per ASTM F2077 and ASTM Draft Z8423Z. In all instances, the Lanx Lateral met acceptance criteria and functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Lanx Fusion System - Lateral
Submitter's Name. Address, Telephone Number, Contact Person and Date Prepared
MAR 2 3 2011
Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021 Phone: 303-443-7500 Facsimile: 303-443-7501
..
Contact Person: Alan Burkholder.
Date Prepared: February 25, 2011
Name of Device and Name/Address of Sponsor
Lanx Fusion System - Lateral (Lanx Lateral)
Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021
Common or Usual Name
Vertebral Body Replacement/Intervertebral Body Fusion Device
Classification Name/Regulation Number
21 CFR § 888.3080, Orthosis, spinal intervertebral fusion
Predicate Devices
Lanx, Inc: Lanx Intervertebral Body/VBR Fusion Device. (K083815) Nuvasive: CoRoent (K071795, K052210)
Intended Use / Indications for Use
When used as a lumbar intervertebral body fusion device, the Lanx Fusion System -Lateral ("Lanx Lateral") 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-SI. DDD is defined as
1
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 Lateral is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System.
When used as vertebral body replacement, the Lanx·Fusion System - Lateral ("Lanx Lateral") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Lateral 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 Lateral is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Lateral 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 the Lanx Fusion System - Lateral ("Lanx Lateral"). The product line includes the Lanx Lateral implant models which include the addition of new footprints and configurations.
All devices in the Lanx Lateral are made of PEEK (OPTIMA®) per ASTM F2026. The PEEK components include Tantalum markers per ASTM F560. The Lanx Lateral has a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Lateral is provided non-sterile.
The devices in this product line have the same or similar intended use and indications, principles of operation, and technological characteristics as the current Lanx Fusion System. The minor difference between the predicate devices and the devices in this product line do not raise any new questions of safety or effectiveness. Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate device.
Performance Data
Performance testing was conducted per ASTM F2077 and ASTM Draft Z8423Z. In all instances, the Lanx Lateral met acceptance criteria and functioned as intended.
Substantial Equivalence
2
The devices included in this product line have the same or similar intended uses, indications, technological characteristics, and principles of operation as previously cleared Lanx Intervertebral Body/VBR Fusion Device (K083815). Performance data demonstrate that these devices do not raise new issues of safety or effectiveness; hence it is as safe and effective as its predicate devices. Thus, the devices are substantially equivalent.
3
Image /page/3/Picture/12 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized eagle-like symbol with three curved lines representing the wings and a simple representation of the body and tail feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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
MAR 2 3 2011
Re: K103666
Trade/Device Name: Lanx Fusion System - Lateral Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MOP Dated: March 01, 2011 Received: March 02, 2011
Dear Mr. Burkholder:
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 iddictions for use stated in the enclosure) to legally marketed predicate devices marketed in intristate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr re 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, list in of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly ability 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 (17 he 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
4
Page 2 - Mr. Alan Burkholder
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 (veporting of medical); device-related adverse events) (21 CFR 803); good manufacturing practice requirements as st forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electoric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-0.050.
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/ucm11188007/phm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Alon, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Prat 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.lda.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 tollofire 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,
erely yours,
N. Melkerson
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): K103666
Device Name: Lanx Fusion System - Lateral
Indications for Use:
When used as a lumbar intervertebral body fusion device; the Lanx Fusion System - Lateral '') 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 at The Lanx Lateral is to be combined with supplemental fixation. Approved supplemental the involved level(s). fixation systems include the Lanx Spinal Fixation System.
When used as vertebral body replacement, the Lanx Fusion System - Lateral ("Lanx Lateral") is indicated for use to replace a verlebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Laxx Lateral 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 Lateral is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Lateral 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 internal fixation is reguired 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)
14
(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 Sign-Off) Division of Surgical, Cithopedic, and Restorative Devices
KID3666 510(k) Number_
FORM FDA 3514 (6/05)