(99 days)
Not Found
No
The document describes a physical implantable device for spinal fusion and vertebral body replacement. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests of the device's structural integrity.
Yes
The Biomet Fusion System is intended for spinal fusion procedures to treat degenerative disc disease and replace resected vertebral bodies, which are clear therapeutic applications.
No
Explanation: The device is an implant for spinal fusion and vertebral body replacement, not for diagnostic purposes.
No
The device description explicitly states that the Biomet Fusion System implants consist of a spacer body with screws and are made from PEEK-OPTIMA® LT1 and titanium alloy. This indicates a physical, hardware-based medical device, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion and vertebral body replacement. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a physical implant made of PEEK and titanium, designed to be surgically inserted into the spine. This is consistent with a medical device, not an IVD.
- Performance Studies: The performance studies listed (static compression, shear, torsion, dynamic compression, expulsion testing, cadaveric study) are all related to the mechanical and structural integrity of a surgical implant, not the performance of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet 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 radios. These patients should have had at least six weeks of non-operative treatment. The Biomet 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 Biomet Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is intended for spinal fusion procedures to be used 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 at the involved level(s). Implants with 20 degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least one integrated fixation screw. The Biomet Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Biomet Spinal Fixation System. The Biomet SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplement fixation.
When used as vertebral body replacement, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") 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 Biomet 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 Biomet Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet 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, ODP, MOP
Device Description
Biomet Fusion System implants consist of a spacer body with screws for additional fixation. The Biomet Fusion System the spacer body is made from PEEK-OPTIMA® LT1, a polyaromatic semicrystalline thermoplastic polymer (-C,Hz-O-C,Hz-O-C,Hz-CO-). The Biomet Fusion System implants include an anterior plate and screws made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136-08 and ISO 5832-3. The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Biomet Fusion System is provided non-sterile.
The implants included in this application are intended for us in lumbar intervertebral body fusion. The implants have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of each implant have a series of transverse grooves formed to improve stability and fixation once the device is inserted.
The purpose of this 510(k) Notification is to seek clearance for a modification to the Lanx Fusion System, for additional configurations. The new implants are also referred to as the Biomet Fusion System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-C3 disc to the C7-T1 disc (cervical spine); L2-S1 (lumbar spine); T1 to L5 (thoracolumbar spine)
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 performed to demonstrate substantial equivalence:
- Static Compression per ASTM F2077
- Static Compression Shear per ASTM F2077
- Static Torsion per ASTM F2077
- Dynamic Compression per ASTM F2077
- Expulsion Testing per ASTM Draft Z8423Z
- Cadaveric Study
In all instances, the Biomet 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.
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the first profile being the most prominent and the other two fading into the background. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2014
Biomet Spine Mr. Ted Kuhn Regulatory Affairs Product Manager 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021
Re: K141791
Trade/Device Name: Biomet Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX, ODP, MOP Dated: September 9, 2014 Received: September 11, 2014
Dear Mr. Kuhn:
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 note: CDRH does not evaluate information related to contract liability 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronaldflygean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141791
Device Name Biomet Fusion System
Indications for Use (Describe)
When used as a cervical intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet 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 radios. These patients should have had at least six weeks of non-operative treatment. The Biomet 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 Biomet Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is intended for spinal fusion procedures to be used 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 at the involved level(s). Implants with 20 degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least one integrated fixation screw. The Biomet Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Biomet Spinal Fixation System. The Biomet SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplement fixation.
When used as vertebral body replacement, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") 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 Biomet 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 Biomet Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif letters. Below it, in smaller letters, is the word "SPINE". The logo is simple and modern, with a focus on the company name.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | September 30, 2014 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 310Interlocken Parkway, Suite 120 | |
| Broomfield, CO 80021 | |
| Contact Person: | Ted Kuhn |
| Regulatory Affairs Project Manager | |
| Phone: 303-501-8549 | |
| Fax: 303-501-8444 | |
| Trade name: | Biomet Fusion System |
| Common Name: | Intervertebral fusion device with bone graft, cervical; |
| Intervertebral fusion device with bone graft, lumbar; | |
| Intervertebral Body Fusion Device with Integrated Fixation, | |
| Lumbar; Vertebral Body Replacement | |
| Classification Name | Orthosis, spinal intervertebral fusion and/or Spinal |
| intervertebral body fixation orthosis. | |
| (Product Code): | (ODP, MAX, OVD, MQP) |
| Device Panel - Regulation No.: | Orthopedic - 21 CFR § 888.3080 and/or § 888.3060 |
Device Description:
Biomet Fusion System implants consist of a spacer body with screws for additional fixation. The Biomet Fusion System the spacer body is made from PEEK-OPTIMA® LT1, a polyaromatic semicrystalline thermoplastic polymer (-C,Hz-O-C,Hz-O-C,Hz-CO-). The Biomet Fusion System implants include an anterior plate and screws made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136-08 and ISO 5832-3. The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Biomet Fusion System is provided non-sterile.
The implants included in this application are intended for us in lumbar intervertebral body fusion. The implants have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of each implant have a series of transverse grooves formed to improve stability and fixation once the device is inserted.
The purpose of this 510(k) Notification is to seek clearance for a modification to the Lanx Fusion System, for additional configurations. The new implants are also referred to as the Biomet Fusion System.
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Indications for Use:
When used as a cervical intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet 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 Biomet 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 Biomet Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet 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). Implants with 20 degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least one integrated fixation screw. The Biomet Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Biomet Spinal Fixation System. The Biomet SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplement fixation.
When used as vertebral body replacement, the Biomet Intervertebral Body/VBR Fusion System ("Biomet 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 Biomet 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 Biomet Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet 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.
Summary of Technologies:
This submission is intended to seek clearance for a product line extension to the Biomet Fusion System. The product line extension includes new configurations of a PEEK spacer body similar to the existing PEEK spacer body of the previously cleared Biomet Fusion System.
All components in the Biomet Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and Titanium alloy (Ti-6A1-4V) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Biomet 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. It
6
comes available with plates and screws to provide additional fixation; however, these are intended to be used with supplemental fixation. The Biomet Fusion System is provided non-sterile.
The additional devices added to the product line have or similar intended use and indications, principles of operation, and technological characteristics as the current Biomet Fusion System. The minor differences between the current devices added to the 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 performed to demonstrate substantial equivalence:
- Static Compression per ASTM F2077 ●
- Static Compression Shear per ASTM F2077 ●
- Static Torsion per ASTM F2077
- Dynamic Compression per ASTM F2077
- Expulsion Testing per ASTM Draft Z8423Z ●
- Cadaveric Study
In all instances, the Biomet Fusion System met acceptance criteria and functioned as intended.
Substantial Equivalence:
The additional devices included in the product line extension have the same or similar intended uses, indications, technological characteristics, and principles of operation as previously cleared primary predicate Lanx Fusion System (K131547). Performance data demonstrate that these additions to the Biomet Fusion System do not raise new issues of safety or effectiveness; hence it is as safe and effective as its predicate devices. Thus, the additional devices are substantially equivalent.
Conclusion:
In summary, the modified Biomet Fusion System has the same or similar: intended use, indications for use, technological characteristics, principles of operation and performances as the previously cleared primary predicate Lanx Fusion System (K131547) and (K123767). Performance testing demonstrates that the modified implants are stronger than or as strong as the predicate implants and provide equivalent performance. Thus, the addition of the new implant models do not raise new questions of safety and efficacy and is substantially equivalent to previous cleared primary predicate Lanx Fusion System (K131547) and K123767).