(267 days)
Not Found
No
The device description and intended use focus solely on the physical characteristics and function of an interbody fusion device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to facilitate fusion in the lumbar and cervical spine for patients with degenerative disc disease, which classifies it as a therapeutic device.
No
This device is an interbody fusion device, designed to facilitate fusion in the spine, not to diagnose medical conditions.
No
The device description clearly details physical implants (cages, screws, markers) made of materials like PEEK and Titanium, intended for surgical implantation. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The text describes the Biolign devices as interbody fusion devices, which are implants made of PEEK or Titanium. They are surgically implanted into the spine to facilitate fusion.
- Intended Use: The intended use is to treat degenerative disc disease by facilitating fusion in the lumbar and cervical spine. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples. The device itself is the therapeutic tool.
The device is a surgical implant used for spinal fusion, which falls under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Biolign® Tlif Interbody Fusion Devices are indicated for use with autograft bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels of the lumbar spine (L2 - S1). DDD is defined as backpain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six (6) months of non-operative therapy. The Biolign® TLIF Intervertebral fusion devices are used to facilitate fusion in the lumbar spine and are implanted via a postero-lateral approach. The Biolign® intervertebral fusion devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine for example posterior pedicle screw and rod systems.
The Biolign® ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign® ACIF System is intended to be used with supplemental fixation systems that have been cleared for in the cervical spine, such as Anterior Cervical plating systems.
The Biolign® STACC ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® STACC ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign STACC ACIF system is intended to be used as a stand-alone system using the bone screws provided for fixation. It may also be used with supplemental fixation system that have been cleared for use in the cervical spine, such as cervical plating systems.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, OVE
Device Description
The Biolign TLIF device is a slightly curved cage manufactured from Invibio PEEK Optima LT1 with cavities which can be packed with autograft. The cage has tantalum markers which allow accurate and correct placement of the device. The cage is postero-laterally inserted. The cage incorporates a threaded introducer hole on each end and has serrated inferior and superior endplates. It is available in two footprints (30x13mm, and 36x13mm), two lordotic angles (5° and 10°), and a range of heights ranging from 6 - 12mm with 1mm intervals These sizing options allow selection for individual pathology and anatomical conditions. The device is used with supplemental fixation such as screw and rod systems. The Biolign® TLIF system is provided sterile.. The System is single use only.
The Biolign ACIF device is an anatomically correct cage manufactured from Invibio PEEK Optima LT1 with a central cavity which can be packed with autograft. The cage is available in two footprints (15 and 17mm) with a 10° lordotic angle. Cage heights range from 6mm-10mm with 1mm intervals. These sizing options allow selection for individual pathology and anatomical conditions. Tantalum radiographic markers enable clear x-ray control during placement and follow-up. The cage endplates are serrated. The Device is inserted below the anterior surface of the cervical vertebrae. It is used with supplemental cervical plating systems which have prominence from the spine (plate thickness). The Biolign® ACIF system is provided sterile The System is for single use only.
The Biolign® STACC ACIF Interbody Fusion Device is a stand-alone device and does not rely on additional fixation such as cervical plates. The device is an anatomically shaped ring, with a central cavity which can be packed with autograft. It is manufactured of Invibio Peek Optima LT1. Two Tantalum pins are placed in the device to enable radiographic visualization for placement and follow-up evaluations. The superior, and inferior endplates of the device are serrated. Two fixation screws per cage are used as supplemental fixation. These screws are placed into the cage and purchase into the vertebral endplates. The fixation screws are manufactured of Titanium 6Al4V ELI. The footprint of the cage is available in one size (17 x 14mm), and in heights ranging from 5.5 - 9.5mm with 1mm intervals. The cage is available in a domed (superior endplate is domed, and inferior endplate has 3° lordosis angle) and a tapered version (8° lordosis - 4° per endplate) The device is implanted using an anterior approach and after implantation does not stand prominent from the cervical spine. It lies below the anterior surface of the cervical spine. The Biolign® STACC ACIF system is supplied sterile. The System is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2 - S1), cervical spine (C3-C7)
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)
Elite Surgical Supplies conducted the following bench testing as recommended by FDA guidances and in accordance with ASTM 2077 and ASTM 2267: Static and Dynamic axial compression, Static shear compression, torsion testing and subsidence testing. Results drawn from the testing performed, as well as from an engineering rationale, demonstrate that the Biolign TLIF spacer is substantially equivalent in performance to the predicate device. Clinical data and conclusions were not needed for this device.
Elite Surgical Supplies conducted the following bench testing as recommended by FDA guidances and in accordance with ASTM 2077: Static axial compression, Static shear compression, and static torsion testing. Results drawn from the testing performed, as well as from an engineering rationale, demonstrate that the Biolign ACIF spacer is substantially equivalent in performance to the predicate device. Clinical data and conclusions were not needed for this device.
Elite Surgical Supplies conducted the following bench testing as recommended by FDA guidances and in accordance with ASTM 2077: Static and dynamic axial compression, Static shear compression, and static and dynamic torsion testing, screw push-out testing, tension offset testing, and impact testing. Results drawn from the testing performed, as well as from an engineering rationale, demonstrate that the Biolign STACC spacer is substantially equivalent in performance to the predicate device. Clinical data and conclusions were not needed for this device.
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.
0
510(k) SUMMARY: K130274
[As required by 21CFR807.92]
OCT 2:9 2013
Image /page/0/Picture/4 description: The image shows a series of horizontal lines of varying lengths and thicknesses. The lines are arranged in a somewhat stacked formation, with some lines appearing to overlap or be positioned closely together. The lines are black and are set against a white background.
ELITE SURGICAL SUPPLIES (PTY) LTD
Contact detail
| 510(k) Summary - Biolign Intervertebral Cages | ||
|---|---|---|
| Prepared | September 11, 2013 | |
| Name of firm | Elite Surgical Supplies (Pty) Ltd. | |
| 184 Bessemer Road, | ||
| Pretoria-West Industrial | ||
| 0183 | ||
| South Africa | ||
| Postal Address | P.O. Box 26115 | |
| Arcadia | ||
| Pretoria | ||
| 0007 | ||
| South Africa | ||
| 510(k) Contact | Rudi Verbeek | |
| Technical Director and Regulatory Affairs | ||
| Tel: +27 12 386 0012 | ||
| Facsimile: +27 12 386 2745 | ||
| Email: rudi@elitesurgical.com | ||
| USA Agent | Charise de Barros | |
| Elite Surgical USA | ||
| 503 Commerce Park Drive, Suite H | ||
| Marietta | ||
| Georgia 30060 | ||
| USA | ||
| Facsimile: 770-590-5152 | ||
| Email: charise@alloutautousa.com |
Elite Surgical Supplies Biolign® Intervertebral Body Fusion Systems Page 1
1
Product detail
| Biolign® Transforaminal Lumbar Intervertebral Fusion (TLIF) device. | |
|---|---|
| Classification | 21 CFR 888.3080 Intervertebral body fusion device |
| Class II (Special Controls) | |
| Orthopaedic and Rehabilitation Devices Panel (87) | |
| Product Code MAX (Intervertebral body fusion device with bone graft, | |
| Lumbar). | |
| Predicates | Spinecraft ORIO-TL - K090887 |
| Device | |
| Description | The Biolign TLIF device is a slightly curved cage manufactured |
| from Invibio PEEK Optima LT1 with cavities which can be packed | |
| with autograft. The cage has tantalum markers which allow | |
| accurate and correct placement of the device. The cage is postero- | |
| laterally inserted. The cage incorporates a threaded introducer hole | |
| on each end and has serrated inferior and superior endplates. It is | |
| available in two footprints (30x13mm, and 36x13mm), two lordotic | |
| angles (5° and 10°), and a range of heights ranging from 6 - 12mm | |
| with 1mm intervals These sizing options allow selection for | |
| individual pathology and anatomical conditions. The device is used | |
| with supplemental fixation such as screw and rod systems. The | |
| Biolign® TLIF system is provided sterile.. The System is single use | |
| only. | |
| Indications | |
| for | |
| use | The Biolign® Tlif Interbody Fusion Devices are indicated for use with |
| autograft bone graft in skeletally mature patients with degenerative | |
| disc disease (DDD) at one level or two contiguous levels of the | |
| lumbar spine (L2 - S1). | |
| DDD is defined as backpain of discogenic origin with degeneration | |
| of the disc confirmed by history and radiographic studies. The DDD | |
| patients may also have up to Grade I spondylolisthesis at the | |
| involved level(s). These patients should be skeletally mature and | |
| have six (6) months of non-operative therapy. | |
| The Biolign® TLIF Intervertebral fusion devices are used to facilitate | |
| fusion in the lumbar spine and are implanted via a postero-lateral | |
| approach. | |
| The Biolign® intervertebral fusion devices are intended to be used | |
| with supplemental fixation systems that have been cleared for use in | |
| the lumbosacral spine for example posterior pedicle screw and rod | |
| systems. | |
| Comparison of | |
| the device to | |
| the predicate | Elite Surgical Supplies' Biolign® TLIF Spacer is substantially |
| equivalent to the predicates in design, function, performance, | |
| material, sterilization and intended use. |
.
.
:
.
:
.
:
Elite Surgical Supplies
Biolign® Intervertebral Body Fusion Systems
Page 2
. .
.
2
| device(s) | |
|---|---|
| Performance | |
| data (Non- | |
| Clinical) | Elite Surgical Supplies conducted the following bench testing as |
| recommended by FDA guidances and in accordance with ASTM | |
| 2077 and ASTM 2267: Static and Dynamic axial compression, Static | |
| shear compression, torsion testing and subsidence testing. | |
| Results drawn from the testing performed, as well as from an | |
| engineering rationale, demonstrate that the Biolign TLIF spacer is | |
| substantially equivalent in performance to the predicate device. | |
| Performance | |
| data (Clinical) | Clinical data and conclusions were not needed for this device. |
| Biolign® Anterior Cervical Interbody Fusion (ACIF) System | |
|---|---|
| Classification | 21 CFR 888.3080 Intervertebral body fusion device |
| Class II (Special Controls) | |
| Orthopaedic and Rehabilitation Devices Panel (87) | |
| Product Code ODP (Intervertebral body fusion device with bone graft, | |
| Cervical). | |
| Predicates | AMT Shell Cervical cage- K080401 |
| Device | |
| Description | The Biolign ACIF device is an anatomically correct cage |
| manufactured from Invibio PEEK Optima LT1 with a central cavity | |
| which can be packed with autograft. The cage is available in two | |
| footprints (15 and 17mm) with a 10° lordotic angle. Cage heights | |
| range from 6mm-10mm with 1mm intervals. These sizing options | |
| allow selection for individual pathology and anatomical conditions. | |
| Tantalum radiographic markers enable clear x-ray control during | |
| placement and follow-up. The cage endplates are serrated. The | |
| Device is inserted below the anterior surface of the cervical | |
| vertebrae. It is used with supplemental cervical plating systems which | |
| have prominence from the spine (plate thickness). The Biolign® ACIF | |
| system is provided sterile The System is for single use only. | |
| Indications for | |
| use | The Biolign® ACIF System is indicated for use as an intervertebral |
| body fusion device in skeletally mature patients with degenerative | |
| disc disease at one level from C3-C7. Cervical disc disease is defined | |
| as discogenic pain with degeneration of the disc confirmed by history | |
| and radiographic studies. Patients should have six (6) weeks of non- | |
| operative treatment. The Biolign® ACIF System is to be used with | |
| autograft bone graft and is implanted via an open anterior approach. | |
| The Biolign® ACIF System is intended to be used with supplemental | |
| fixation systems that have been cleared for in the cervical spine, such | |
| as Anterior Cervical plating systems. | |
| Comparison of | |
| the device to | |
| the predicate | Elite Surgical Supplies' Biolign® ACIF Spacer is substantially |
| equivalent to the predicates in design, function, performance, | |
| material, sterilization and intended use. |
Elite Surgical Supplies
Biolign® Intervertebral Body Fusion Systems
Page 3
: .
3
| device(s) | |
|---|---|
| Performance | |
| data (Non- | |
| Clinical) | Elite Surgical Supplies conducted the following bench testing as |
| recommended by FDA guidances and in accordance with ASTM | |
| 2077: Static axial compression, Static shear compression, and static | |
| torsion testing. | |
| Results drawn from the testing performed, as well as from an | |
| engineering rationale, demonstrate that the Biolign ACIF spacer is | |
| substantially equivalent in performance to the predicate device. | |
| Performance | |
| data (Clinical) | Clinical data and conclusions were not needed for this device. |
| Biolign® Stand Alone Cervical Cage (STACC) ACIF System | |
|---|---|
| Classification | 21 CFR 888.3080 Intervertebral body fusion device |
| Class II (Special Controls) | |
| Orthopaedic and Rehabilitation Devices Panel (87) | |
| Product Code OVE (Intervertebral fusion device with integrated | |
| fixation, cervical). | |
| Predicates | Surgicraft Ltd Stalif - K072415 |
| Device | |
| Description | The Biolign® STACC ACIF Interbody Fusion Device is a stand- |
| alone device and does not rely on additional fixation such as | |
| cervical plates. The device is an anatomically shaped ring, with a | |
| central cavity which can be packed with autograft. It is | |
| manufactured of Invibio Peek Optima LT1. Two Tantalum pins are | |
| placed in the device to enable radiographic visualization for | |
| placement and follow-up evaluations. The superior, and inferior | |
| endplates of the device are serrated. Two fixation screws per cage | |
| are used as supplemental fixation. These screws are placed into | |
| the cage and purchase into the vertebral endplates. The fixation | |
| screws are manufactured of Titanium 6Al4V ELI. The footprint of | |
| the cage is available in one size (17 x 14mm), and in heights | |
| ranging from 5.5 - 9.5mm with 1mm intervals. The cage is available | |
| in a domed (superior endplate is domed, and inferior endplate has | |
| 3° lordosis angle) and a tapered version (8° lordosis - 4° per | |
| endplate) The device is implanted using an anterior approach and | |
| after implantation does not stand prominent from the cervical spine. | |
| It lies below the anterior surface of the cervical spine. The Biolign® | |
| STACC ACIF system is supplied sterile. The System is for single | |
| use only. | |
| Indications | |
| for use | The Biolign® STACC ACIF System is indicated for use as an |
| intervertebral body fusion device in skeletally mature patients with | |
| degenerative disc disease at one level from C3-C7. Cervical disc | |
| disease is defined as discogenic pain with degeneration of the disc | |
| confirmed by history and radiographic studies. Patients should have |
Elite Surgical Supplies
Biolign® Intervertebral Body Fusion Systems
4
| | six (6) weeks of non-operative treatment. The Biolign® STACC ACIF
System is to be used with autograft bone graft and is implanted via
an open anterior approach. The Biolign STACC ACIF system is
intended to be used as a stand-alone system using the bone screws
provided for fixation. It may also be used with supplemental fixation
system that have been cleared for use in the cervical spine, such as
cervical plating systems. |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
the device to
the predicate
device(s) | Elite Surgical Supplies' Biolign® STACC Spacer is substantially
equivalent to the predicates in design, function, performance,
material, sterilization and intended use. |
| Performance
data (Non-
Clinical) | Elite Surgical Supplies conducted the following bench testing as
recommended by FDA guidances and in accordance with ASTM
2077: Static and dynamic axial compression, Static shear
compression, and static and dynamic torsion testing, screw push-out
testing, tension offset testing, and impact testing.
Results drawn from the testing performed, as well as from an
engineering rationale, demonstrate that the Biolign STACC spacer is
substantially equivalent in performance to the predicate device. |
| Performance
data (Clinical) | Clinical data and conclusions were not needed for this device. |
Elite Surgical Supplies
Biolign® Intervertebral Body Fusion Systems
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2013
Elite Surgical Supplies (Pty) Limited Mr. Rudi Verbeek Technical Director P.O. Box 26115 Arcadia Pretoria 0007 South Africa
Re: K130274
Trade/Device Name: Biolign® ACIF System Biolign® STACC ACIF System Biolign® TLIF Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE, MAX, ODP Dated: September 11, 2013 Received: September 25, 2013
Dear Mr. Verbeek:
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 Control Concession Company Construction of Children ・・・・・・・・・・・・
6
Page 2 - Mr. Rudi Verbeek
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/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 Small Manufacturers, International and Consumer Assistance 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,
Erin=FDKéith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use ·
510(k) Number (if known) K130274
Device Name Biolign® ACIF System
Indications for Use (Describe)
The Biolign® ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature paients with degenerative disc disease at one level from C3-C7. Cervical discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign® ACIF System is intended to be used with supplemental fixation systems such as Anterior Cervical plating systems.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitri Division of Orthopied
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K130274
Device Name
Biolign® TLIF Intervertebral Body Fusion Device
Indications for Use (Describe)
The Biolign® TLIF Intervertebral Body Fusion Devices are indicated for use with autograft bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels of the lumbar spine (L2 - S1).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDd patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six {6) months of non-operative therapy.
The Biolign® TLIF Intervertebral Body Fusion Devices are used to facilitate fusion in the lumbar spine and are implanted via a postero-lateral approach.
The Biolign® Intervertebral Body Fusion Devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine, for example posterior pedicle screw and rod systems.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Division o
9
Indications for Use
510(k) Number (if known) K130274
Device Name Biolign® STACC ACIF System
Diognes STRCC RICH System
Indications for Use (Describe)
The Biolign® STACC ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® STACC ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign® STACC ACIF system is intended to be used as a stand-alone screws provided for fixation. It may also be used with supplemental fixation systems that have been cleared for use in the cervical spine, such as cervical plating systems.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitri Division of Orthopedic
FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.