← Product Code [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX) · K082774 # LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (K082774) _Lanx, LLC · MAX · Oct 21, 2008 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K082774 ## Device Facts - **Applicant:** Lanx, LLC - **Product Code:** [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX.md) - **Decision Date:** Oct 21, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use When used as a cervical intervertebral body fusion device, the Lanx Small Intervertebral Body/VBR 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 Small Intervertebral Body/VBR 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. Approved supplemental fixation systems include the Lanx Spinal Fixation System. When used as vertebral body replacement, the Lanx Small Intervertebral Body/VBR Fusion 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 turnors 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. ## Device Story Intervertebral body fusion and vertebral body replacement device; implanted via anterior or posterior approach; used with autogenous bone graft to facilitate fusion; requires supplemental internal fixation. Device features hollowed area for bone graft and transverse grooves for stability; available in various sizes to accommodate patient anatomy. Used by surgeons in clinical settings to treat DDD, tumors, or fractures; restores biomechanical integrity of spinal column and vertebral height. Benefits include spinal stabilization and decompression of neural tissues. ## Clinical Evidence Bench testing only. Testing conducted per ASTM F2077-03 and ASTM F2267-04; device met all acceptance criteria. ## Technological Characteristics Materials: PEEK-OPTIMA or titanium alloy. Features: hollowed area for bone graft, transverse grooves for fixation. Dimensions: variable sizes. Connectivity: N/A. Sterilization: non-sterile. Standards: ASTM F2077-03, ASTM F2267-04. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Globus Medical, Inc.'s Patriot Spacers: Colonial ACDF - Spinal Elements, Inc.'s Crystal - SpineSmith Partners L.P.'s Cimplicity Spinal System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K082774 (pg. 1 of 3) ## 510(k) SUMMARY #### Lanx's Small Intervertebral Body/VBR Fusion Device OCT 2 1 2008 #### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021 Phone: 303-443-7500 Facsimile: 303-443-7501 Contact Person: Alan Burkholder Date Prepared: October 17, 2008 ## Name of Device and Name/Address of Sponsor Lanx Small Intervertebral Body/VBR Fusion Device Lanx, Inc. 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021 ## Common or Usual Name Intervertebral Body Fusion Device #### Classification Name Orthosis, spinal intervertebral fusion ## Predicate Devices Globus Medical, Inc.'s Patriot Spacers: Colonial ACDF Spinal Elements, Inc.'s Crystal SpineSmith Partners L.P.'s Cimplicity Spinal System {1}------------------------------------------------ 60827 (pg. 2 of 3) ## Intended Use / Indications for Use When used as a cervical intervertebral body fusion device, the Lanx Small Intervertebral Body/VBR 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 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 Small Intervertebral Body/VBR 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. Approved supplemental fixation systems include the Lanx Spinal Fixation System. When used as vertebral body replacement, the Lanx Small Intervertebral Body/VBR 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 vertebrectory) of a diseased vertebral body resected or excised for the treatment of turnors 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 The Lanx Small Intervertebral Body/VBR Fusion system is made of PEEK-OPTIMA® or titanium alloy. The Fusion System 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 Small Intervertebral Body/VBR Fusion System is provided non-sterile. # Performance Data {2}------------------------------------------------ Performance testing was conducted per ASTM F2077-03 and ASTM F2267-04. In all instances, the Lanx Small Intervertebral Body/VBR Fusion System met acceptance criteria and functioned as intended. K082774 P9. 3 of 3) # Substantial Equivalence The Lanx Small Intervertebral Body/VBR Fusion Device is as safe and effective as the Globus Medical, Inc. Patriot Spacers: Colonial ACDF, the Spinal Elements, Inc. Crystal, and the SpineSmith Partners L.P. Cimplicity Spinal System. The Lanx Small Intervertebral Body/VBR Fusion Device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Lanx Small Intervertebral Body/VBR Fusion Device and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Lanx Small Intervertebral Body/VBR Fusion Device is as safe and effective as the predicate devices. Thus, the Lanx Small Intervertebral Body/VBR Fusion Device is substantially equivalent. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is presented in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # OCT 2 1 2008 Lanx, LLC % Mr. Alan Burkholder Senior Project Engineer 390 Interlocken Crescent, Suite 890 Broomfield, Colorado 80021 Re: K082774 > Trade Name: Lanx Small Intervertebral Body/VBR Fusion Device Regulation Number(s): 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device. Regulatory Class: Class II Product Code: ODP, MAX, MOP Dated: September 18, 2008 Received: September 22, 2008 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 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. {4}------------------------------------------------ Page 2 – Mr. Alan Burkholder This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. 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 premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Mark M. Millerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ | 510(k) Number (if known): | K082774 | |---------------------------|-------------------------------| | | Indications for Use Statement | Device Name: Lanx Small Intervertebral Body/VBR Fusion Device Indications for Use: When used as a cervical intervertebral body fusion device, the Lanx Small Intervertebral Body/VBR 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 Small Intervertebral Body/VBR 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. Approved supplemental fixation systems include the Lanx Spinal Fixation System. When used as vertebral body replacement, the Lanx Small Intervertebral Body/VBR Fusion 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 turnors 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. 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 General, Restorative, Neurological Devices 710(k) Number K082774 Page *1* of *1* --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K082774](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K082774) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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