(335 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "indicated for intervertebral body fusion of the spine" and "designed for use with autograft to facilitate fusion," which directly relates to treating a medical condition (degenerative disc disease) by restoring stability and promoting fusion.
No
The A-Link Z is an implanted spinal device intended for intervertebral body fusion. Its purpose is to physically stabilize the spine and support fusion, not to diagnose medical conditions.
No
The device description clearly states it is a spinal implant made of PEEK and titanium alloy, which are physical materials, not software. The performance studies also focus on mechanical testing of the physical 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. It is used in vivo (within the body) to provide structural support and facilitate bone growth.
- Device Description: The description details the materials and design of a physical implantable device (interbody components, plate, screws, cover plate).
- Performance Studies: The performance studies focus on the mechanical properties and structural integrity of the implant under various loads, which are relevant to surgical implants, not diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device does not fit that description.
N/A
Intended Use / Indications for Use
A-Link Z is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral body space.
A-Link Z is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
A-Link Z may be used as a stand alone device when all four (4) vertebral body bone screws are used. If the physician chooses to use fewer than the four (4) screws, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.
Product codes
OVD
Device Description
The A-Link Z is a spinal device that is implanted in the intervertebral body space to improve stability of the spine while supporting fusion. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy.
The interbody components are manufactured using medical grade polyetheretherketone (PEEK) conforming to ASTM D2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The PEEK version of the interbody comes with two tantalum markers conforming to ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications to facilitate implant placement. The A-Link Z is available in one footprint (36 mm wide). It has an anatomic shape with serrations on the superior and inferior surfaces. The A-Link Z is available in two lordotic angle options (7° and 12°). The 7° lordotic option has heights ranging from 11 mm in 2 mm increments and the 12° lordotic option has heights ranging from 11 mm to 19 mm increments.
The interbody comes with a press fit plate manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136. The plate has four screw holes that allow the passage of bone screws.
The 5.0 mm and 5.5 mm diameter bone screws are available in three lengths (20 mm, 25 mm and 30 mm). The screws are manufactured from titanium alloy, Ti-6A1-4V ELI according to ASTM F136. The A-Link Z is fixed to the adjacent vertebral bodies through the use of four screws inserted through anterior screw holes of the implant.
The screws are prevented from backing out after insertion by the attachment of a cover plate and a cover plate screw to the anterior side of the plate. The cover plate and cover plate screw are manufactured from titanium alloy, Ti-6A1-4V ELI according to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, from L2 to S1
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use
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
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: performance testing, engineering analysis and dimensional analysis. Performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. The following testing was performed:
- Static & Dynamic Compression testing per ASTM F2077
- Static & Dynamic Torsion testing per ASTM F2077
- Static & Dynamic Compression Shear testing per ASTM F2077
- Expulsion testing
- Subsidence testing per ASTM F2267
Static tensile testing also was performed to measure the force required to separate (pull) the device face plate component from the interbody spacer component.
Clinical data were not submitted in this premarket notification.
Key Metrics
Not Found
Predicate Device(s)
K102090, K071922, K110327, K080314, K123767, K120345, K073109, K091301, K111626
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2014
OsteoVasive, LLC % Kevin A. Thomas, Ph.D. PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K133827
Trade/Device Name: A-Link Z Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: October 20, 2014 Received: October 21, 2014
Dear Dr. Thomas:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Kevin A. Thomas, Ph.D.
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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Device Name
A-Link Z
Indications for Use (Describe)
A-Link Z is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral body space.
A-Link Z is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
A-Link Z may be used as a stand alone device when all four (4) vertebral body bone screws are used. If the physician chooses to use fewer than the four (4) screws, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary OsteoVasive LLC A-Link Z
K133827
November 13, 2014
ADMINISTRATIVE INFORMATION
| Manufacturer Name | OsteoVasive LLC
14215 Proton Road
Dallas, TX 75244 | |
|---------------------------|----------------------------------------------------------|------------------------------------------|
| | Telephone: | +1 (214) 405-2870 |
| | Fax: | +1 (214) 960-4313 |
| Official Contact | Bryan Cowan | |
| | President | |
| Representative/Consultant | Kevin A. Thomas, Ph.D. | |
| | Floyd G. Larson | |
| | PaxMed International, LLC | |
| | 12264 El Camino Real, Suite 400 | |
| | San Diego, CA 92130 | |
| | Telephone: | +1 (858) 792-1235 |
| | Fax: | +1 (858) 792-1236 |
| | Email: | kthomas@paxmed.com
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | A-Link Z |
|---|---|
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral fusion device with integrated fixation |
| Classification Regulations | 21 CFR 888.3080, Class II |
| Product Code | OVD |
| Classification Panel | Orthopedic |
| Reviewing Branch | Anterior Spine Devices Branch |
4
INTENDED USE
A-Link Z is indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral body space.
A-Link Z is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
A-Link Z may be used as a stand alone device when all four (4) vertebral body bone screws are used. If the physician chooses to use fewer than the four (4) screws, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine must be used.
DEVICE DESCRIPTION
The A-Link Z is a spinal device that is implanted in the intervertebral body space to improve stability of the spine while supporting fusion. Components are offered in different shapes and sizes to meet the requirements of the individual patient anatomy.
The interbody components are manufactured using medical grade polyetheretherketone (PEEK) conforming to ASTM D2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The PEEK version of the interbody comes with two tantalum markers conforming to ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications to facilitate implant placement. The A-Link Z is available in one footprint (36 mm wide). It has an anatomic shape with serrations on the superior and inferior surfaces. The A-Link Z is available in two lordotic angle options (79 and 12°). The 7° lordotic option has heights ranging from 11 mm in 2 mm increments and the 12° lordotic option has heights ranging from 11 mm to 19 mm increments.
The interbody comes with a press fit plate manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136. The plate has four screw holes that allow the passage of bone screws.
The 5.0 mm and 5.5 mm diameter bone screws are available in three lengths (20 mm, 25 mm and 30 mm). The screws are manufactured from titanium alloy, Ti-6A1-4V ELI according to ASTM F136. The A-Link Z is fixed to the adjacent vertebral bodies through the use of four screws inserted through anterior screw holes of the implant.
The screws are prevented from backing out after insertion by the attachment of a cover plate and a cover plate screw to the anterior side of the plate. The cover plate and cover plate screw are manufactured from titanium alloy, Ti-6A1-4V ELI according to ASTM F136.
5
If the physician chooses to use fewer than the four screws, then an additional supplemental spinal fixation system cleared for use in the lumbosacral spine should be used.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included: performance testing, engineering analysis and dimensional analysis. Performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. The following testing was performed:
- . Static & Dynamic Compression testing per ASTM F2077
- Static & Dynamic Torsion testing per ASTM F2077
- Static & Dynamic Compression Shear testing per ASTM F2077 ●
- Expulsion testing
- Subsidence testing per ASTM F2267
Static tensile testing also was performed to measure the force required to separate (pull) the device face plate component from the interbody spacer component.
Clinical data were not submitted in this premarket notification.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent to the following predicate devices:
- . SpineSmith Partners, LP, Cynch Spinal System – Visualif Interbody Fusion Implant System (K102090)
- RSB Spine, LLC, InterPlate® (K071922) ●
- LDR Spine USA, LDR Spine ROI-A Implant System (K110327)
- Spinal USA, Spinal USA Interbody Fusion Device (K080314)
- Lanx, Inc., Lanx Lateral-SA System (K123767)
- Nexxt Spine, LLC, Honour Spacer System (K120345)
- Surgicraft Ltd., Stalif™ TT Intervertebral Body Fusion System (K073109) ●
- Life Spine, Inc., Life Spine Stand-Alone Spacer System (K091301)
- . Titan Spine, LLC, Endoskeleton® TAS (K111626)
The primary predicate device is K102090.
The implants of the subject device, A-Link Z, have footprint, height, and lordotic angle similar to those of implants cleared in K102090, K110327, K080314, K123767, K073109, K091301, and K111626. The screws of the subject device have dimensions similar to those of screws cleared in
6
K102090, K123767, and K091301. The screw locking mechanism of the subject device is similar to that of devices cleared in K102090, K071922, K123767, and K091301. The materials of the subject device are identical to those of devices cleared in K080314, K123767, K120345, and K111626. The subject device is gamma sterilized similarly to the device cleared in K110327.
CONCLUSIONS
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including length, width, height, and lordotic angle of the implant and length and diameter of the screws. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
Overall, A-Link Z has the following similarities to the predicate devices:
- has the same intended use,
- . uses the same operating principle.
- . incorporates the same basic design,
- incorporates the same or very similar materials, and ●
- has similar packaging and is sterilized using the same materials and processes. ●