(78 days)
The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use 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,
The Lanx Fusion System is made of PEEK-OPTIMA® 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 accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.
Here's an analysis of the provided text regarding the Lanx, LLC's Intervertebral Body Fusion Device, focusing on acceptance criteria and supporting studies:
Summary of Acceptance Criteria and Device Performance for Lanx Intervertebral Body Fusion Device (K073144)
Based on the provided 510(k) summary, the device is a mechanical implant, and its performance evaluation relies on engineering standards rather than clinical study endpoints that would involve human physiological measures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM F2077-03 | Met acceptance criteria and functioned as intended. |
| ASTM F2267-04 | Met acceptance criteria and functioned as intended. |
Explanation of the Standards:
- ASTM F2077-03: Standard Test Methods for Intervertebral Body Fusion Devices - This standard covers static and fatigue compression, compression-shear, and torsion testing methods for intervertebral body fusion devices. It establishes a repeatable method for the mechanical evaluation of these implants.
- ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression - This standard describes a method for measuring the subsidence (or sinking) of an intervertebral body fusion device into vertebral bone under static axial compression. It helps assess the short-term stability and potential for implant migration.
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify the exact sample sizes (number of devices tested) for the ASTM F2077-03 and ASTM F2267-04 tests. These standards typically define minimum sample sizes for reliable testing, but the specific number used by Lanx, LLC is not disclosed in this summary.
- Data Provenance: The data is from engineering performance testing, not human clinical data. Therefore, there is no country of origin or retrospective/prospective classification in the context of clinical studies. The testing was conducted by Lanx, LLC or a contracted lab under their purview.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable to this device. As discussed, the device underwent mechanical engineering testing to established ASTM standards. Ground truth for these tests is defined by the physical properties and performance characteristics dictated by the standards themselves, not by expert medical interpretation of images or patient outcomes.
4. Adjudication Method for the Test Set
- This question is not applicable to this device. Adjudication methods (like 2+1, 3+1 consensus) are used for clinical trials or image interpretation studies where expert consensus is needed to establish a "ground truth" for diagnostic accuracy. For engineering tests, the "ground truth" is defined by the measurement protocols and pass/fail criteria of the specified ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the diagnostic performance of software, particularly in imaging, to see how it affects human reader performance. The Lanx Intervertebral Body Fusion Device is a physical implant, not a diagnostic or AI-powered imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable to this device. A standalone performance study refers to the performance of an AI algorithm without human intervention, typically in diagnostic tasks. The Lanx device is a physical implant, so this concept does not apply.
7. The Type of Ground Truth Used
- The "ground truth" for the performance data in this instance is compliance with pre-defined mechanical engineering standards (ASTM F2077-03 and ASTM F2267-04). These standards define the expected mechanical behavior (e.g., strength, stiffness, fatigue resistance, subsidence) of intervertebral body fusion devices. The device met these objective, measurable criteria.
8. The Sample Size for the Training Set
- This question is not applicable to this device. "Training set" refers to data used to train machine learning models. The Lanx Intervertebral Body Fusion Device is a physical implant, not an AI or machine learning product. Its design and performance are based on engineering principles and materials science, not statistical learning from a training dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable to this device for the reasons stated in point 8.
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510(k) SUMMARY
Lanx, LLC's Intervertebral Body Fusion Device
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Lanx, LLC 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021
Contact Person: Greg Causey Phone: 303-443-7500 Facsimile: 303-443-7501
Date Prepared: November 4, 2007
JAN 2 4 2003
Name of Device and Name/Address of Sponsor
Lanx Intervertebral Body Fusion Device
Lanx, LLC 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021
Common or Usual Name
Intervertebral Body Fusion Device
Classification Name
.
Orthosis, spinal intervertebral fusion
Predicate Devices
Zimmer Spine, Inc. BAK™ Vista Interbody Fusion System DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spine System Lanx, LLC, Lanx Vertebral Body Replacement Device
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Intended Use / Indications for Use
The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use 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,
Technological Characteristics
The Lanx Fusion System is made of PEEK-OPTIMA® 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 accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.
Performance Data
Performance testing was conducted per ASTM F2077-03 and ASTM F2267-04. In all instances, the Lanx Fusion System met acceptance criteria and functioned as intended.
Substantial Equivalence
The Lanx Fusion System is as safe and effective as the previously cleared Lanx Vertebral Body Replacement Device and the previously approved, and now reclassified, Zimmer Spine, Inc. BAKTM Vista Interbody Fusion System and the DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP® Spine System (the "Predicate Devices").
The Lanx Fusion System has the same intended use/indications, and similar technological characteristics and principles of operation as its predicate devices. The minor technological differences between the Lanx Fusion System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Lanx Fusion System is as safe and effective as the predicate devices. Thus, the Lanx Fusion System is substantially equivalent.
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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2008
Lanx, LLC % Mr. Greg Causey 390 Interlocken Crescent, Suite 890 Broomfield, CO 80021
Re: K073144
Trade/Device Name: Lanx Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: November 6, 2007 Received: November 7, 2007
Dear Mr. Causey:
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.
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Page 2 - Mr. Greg Causey
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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K073144
Device Name: Lanx Intervertebral Body Fusion Device
Indications for Use:
The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use with autogenous bone graft in skeletally mature patients with degenerative 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 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 supplimental fixation systems include the Lanx Spinal Fixation System.
| Prescription Use_X | AND/OR | Over-The-Counter Use_ |
|---|---|---|
| (Part 21 C.F.R. 801 Subpart D) | (21 C.F.R. 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark A. Millham
(Division of General, Restorative, and Non-ologica
510(h) Number
§ 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.