Who is the manufacturer of BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM?

Elite Surgical Supplies (Pty), Ltd. filed the 510(k) submission for BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM (K130274).

What is the FDA product code for BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM?

MAX. It is classified under 21 CFR 888.3080 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM?

Spinecraft ORIO-TL (K090887); AMT Shell Cervical cage (K080401); Surgicraft Ltd Stalif (K072415).

Who can help prepare an FDA 510(k) submission like BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM

K130274 · Elite Surgical Supplies (Pty), Ltd. · MAX · Oct 29, 2013 · Orthopedic

Device Facts

Record ID	K130274
Device Name	BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM
Applicant	Elite Surgical Supplies (Pty), Ltd.
Product Code	MAX · Orthopedic
Decision Date	Oct 29, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3080
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Biolign Intervertebral Body Fusion Systems (TLIF, ACIF, STACC) are spinal implants designed to facilitate fusion. TLIF and ACIF cages are manufactured from PEEK Optima LT1 with tantalum markers for radiographic visualization; they feature serrated endplates and central cavities for autograft packing. STACC ACIF is a stand-alone cage including titanium 6Al4V ELI fixation screws. Devices are implanted by surgeons via postero-lateral (TLIF) or anterior (ACIF/STACC) approaches. Cages provide structural support to the disc space during fusion; supplemental fixation (plates or pedicle screws) is typically used, except for the stand-alone STACC configuration. Benefits include stabilization of the spinal segment and promotion of arthrodesis in patients with degenerative disc disease.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing only.

Technological Characteristics

Materials: Invibio PEEK Optima LT1, Titanium 6Al4V ELI (screws), Tantalum (markers). Standards: ASTM 2077, ASTM 2267. Design: Serrated endplates, central graft cavity, lordotic angles. Sterilization: Provided sterile. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous lumbar levels (L2-S1) or one cervical level (C3-C7). Patients must have failed 6 weeks (cervical) or 6 months (lumbar) of non-operative therapy. Lumbar patients may have up to Grade I spondylolisthesis. Used with autograft bone graft.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

Spinecraft ORIO-TL (K090887)
AMT Shell Cervical cage (K080401)
Surgicraft Ltd Stalif (K072415)

Related Devices

K151408 — LOSPA IS Spinal System · Corentec Co., Ltd. · Oct 2, 2015
K221535 — Align Lumbar Interbody Fusion System · Acuity Surgical Devices, LLC · Jul 22, 2022
K101085 — SPINESMITH CYNCH SPINAL SYSTEM · Spine Smith Partners L.P. · Jul 1, 2010
K143163 — AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · Jan 26, 2015
K171749 — Velofix(tm) Interbody Fusion System · U&I Corporation · Jul 13, 2017

Submission Summary (Full Text)

{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.