SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer

K143578 · Globus Medical, Inc. · MAX · Apr 13, 2016 · Orthopedic

Device Facts

Record IDK143578
Device NameSUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
ApplicantGlobus Medical, Inc.
Product CodeMAX · Orthopedic
Decision DateApr 13, 2016
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3080
Device ClassClass 2
AttributesTherapeutic

Intended Use

When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN® R TPS) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE® or BEACON® Stabilization Systems. When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems. When used as vertebral body replacement devices, SUSTAIN® Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Story

Spacers (SUSTAIN, PATRIOT, CALIBER, COALITION, INDEPENDENCE, FORTIFY, XPand, NIKO) provide structural stability in spine following discectomy, corpectomy, or vertebrectomy. Devices are PEEK polymer or titanium alloy, with some featuring titanium plasma spray (TPS) coating. Spacers are inserted into intervertebral space or used for vertebral body replacement; axial holes allow packing with autogenous bone graft or allograft. Protrusions on surfaces grip endplates to resist expulsion. Some models (COALITION, INDEPENDENCE, FORTIFY Integrated) include integrated screws for fixation. Used in OR by surgeons; supplemental fixation systems required for most models. Provides anterior column support; facilitates fusion. Benefits include structural restoration and stabilization of spinal segments.

Clinical Evidence

Bench testing only. Performance evaluated per Class II Special Controls Guidance for Intervertebral Fusion Devices. Testing included dynamic compression, shear, and torsion (ASTM F2077) and comprehensive coating characterization (ASTM F1044, F1147, F1160, F1854, F1978) to ensure coating integrity and wear resistance.

Technological Characteristics

Materials: PEEK (ASTM F2026), titanium alloy (ASTM F136, F1295), commercially pure titanium (ASTM F67), tantalum markers (ASTM F560), hydroxyapatite coating (ASTM F1185). Features: TPS coating (ASTM F1580). Form factor: Various shapes/heights for spinal approaches. Connectivity: N/A. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1) or one level of the cervical spine (C2-T1), or for vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma. Lumbar DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months non-operative treatment for lumbar or 6 weeks for cervical.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 13, 2016 Globus Medical Incorporated Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403 Re: K143578 Trade/Device Name: SUSTAIN® R TPS Spacers, PATRIOT® TPS Spacers, CALIBER® TPS Spacer, COALITION® TPS Spacers, INDEPENDENCE® TPS Spacer, FORTIFY®-R TPS Corpectomy Spacer, FORTIFY® I-R TPS Corpectomy Spacer, XPand®-R TPS Corpectomy Spacer, NIKO® TPS Corpectomy Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, OVD, OVE, MQP Dated: April 5, 2016 Received: April 6, 2016 Dear Dr. Baker: 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 {1}------------------------------------------------ Page 2 - Kelly J. Baker, Ph.D. (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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, Ronald P. Jean -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 510(k) Number (if known) K143578 #### Device Name SUSTAIN® R TPS Spacers, PATRIOT® TPS Spacer, CALIBER® TPS Spacer, COALITION® TPS Spacers, INDEPENDENCE® TPS Spacer, FORTIFY®-R TPS Corpectomy Spacer, FORTIFY® I-R TPS Corpectomy Spacer, XPand®-R TPS Corpectorny Spacer, NIKO® TPS Corpectomy Spacer #### Indications for Use (Describe) #### SUSTAIN® Spacers When used as lumbar intervertebral body fusion devices, SUSTAIN® SUSTAIN® R and SUSTAIN® R TPS) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE®, REVOLVE®, or BEACON® Stabilization Systems. When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be sketally mature and have had at least six (6) weeks of non-operative treatment. SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®. PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems. When used as vertebral body replacement devices, SUSTAIN® Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. #### PATRIOT® Lumbar Spacers PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental® TPS, TransContinental® M, and TransContinental® M TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (0) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation. #### PATRIOT® Cervical Spacers PATRIOT® Spacers (including COLONIAL® and COLONIAL® TPS) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems. {3}------------------------------------------------ ### CALIBER® Spacers CALIBER® Spacers (including CALIBER® TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems. ### COALITION® Spacers COALITION® Spacers (including COALITION® TPS) are stand-alone interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. COALITION® Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implants. ### INDEPENDENCE® Spacers INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autogenous bone graft material, and are to be used with three titanium alloy screws, which accompany the implants. #### FORTIFY® Corpectomy Spacers FORTIFY® (including FORTIFY®-R TPS) and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allografi. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. ### XPand® Corpectomy Spacers XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). XPand® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. ### NIKO® Corpectomy Spacers NIKO® Corpectomy Spacers (including NIKO® TPS) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). NIKO® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. NIKO® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. {4}------------------------------------------------ X Prescription Use (Part 21 CFR 801 Subpart D) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 510(k) Summary: TPS Spacers | Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800 | |-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Kelly J. Baker, Ph.D.<br>Senior Vice President, Regulatory and Clinical Affairs | | Date Prepared: | February 25, 2016 | | Device Name: | SUSTAIN® R TPS Spacers<br>PATRIOT® TPS Spacers<br>CALIBER® TPS Spacer<br>COALITION® TPS Spacers<br>INDEPENDENCE® TPS Spacer<br>FORTIFY®-R TPS Corpectomy Spacer<br>FORTIFY® I-R TPS Corpectomy Spacer<br>XPand®-R TPS Corpectomy Spacer<br>NIKO® TPS Corpectomy Spacer | | Classification: | Per 21 CFR as follows:<br>§888.3060 Spinal Intervertebral Body Fixation Orthosis<br>§888.3080 Intervertebral Body Fusion Device<br>Product Code(s):<br>MQP SUSTAIN® R TPS Spacers (Cervical & Lumbar)<br>FORTIFY®-R TPS Corpectomy Spacer<br>FORTIFY® I-R TPS Corpectomy Spacer<br>XPand®-R TPS Corpectomy Spacer<br>NIKO® TPS Corpectomy Spacer<br>MAX SUSTAIN® R TPS Spacers (Lumbar)<br>PATRIOT® TPS Spacers (Lumbar)<br>CALIBER® TPS Spacer<br>ODP SUSTAIN® R TPS Spacers (Cervical)<br>PATRIOT® TPS Spacers (Cervical)<br>COALITION® TPS Spacers<br>OVE COALITION® TPS Spacers<br>OVD INDEPENDENCE® TPS Spacer<br>Regulatory Class: II, Panel Code: 87 | Primary Predicate: Aurora Spine Interbody Fusion System (K133967) {6}------------------------------------------------ | Additional<br>Predicates: | SUSTAIN® R Spacers (K040284 & K130478) | |---------------------------|-----------------------------------------------| | | PATRIOT® Spacers (Cervical) (K072991) | | | PATRIOT® Spacers (Lumbar) (K072970 & K122097) | | | PATRIOT® TransContinental® Spacer (K093242) | | | PATRIOT® TransContinental® M Spacer (K102313) | | | CALIBER® Spacer (K102293 & K123231) | | | COALITION® Spacer (K083389 & K131449) | | | INDEPENDENCE® Spacer (K082252 & K120101) | | | FORTIFY®-R Corpectomy Spacer (K112756) | | | FORTIFY® I-R Corpectomy Spacer (K121107) | | | XPand®-R Corpectomy Spacer (K060665) | | | NIKO® Corpectomy Spacer (K072465) | ## Purpose: The purpose of this submission is to request clearance of the following titanium plasma spray coated PEEK spacers: SUSTAIN® R TPS Spacers, PATRIOT® TPS Spacers, CALIBER® TPS Spacer, COALITION® TPS Spacers, INDEPENDENCE® TPS Spacer, FORTIFY®-R TPS Corpectomy Spacer, FORTIFY® I-R Corpectomy TPS Spacer, XPand -R TPS Corpectomy Spacer, and NIKO® TPS Corpectomy Spacer. ## Device Description: ### SUSTAIN® Spacers SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN® R TPS) are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. These spacers are available in different shapes and heights to accommodate various surqical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). Lumbar spacers may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral lumbar approach. Cervical spacers are inserted using an anterior cervical approach. The SUSTAIN® Spacers are made from commercially pure titanium or titanium alloy as specified in ASTM F67, F136, and F1295. SUSTAIN® Radiolucent (SUSTAIN® R) and SUSTAIN® R TPS Spacers are made from radiolucent PEEK polymer with titanium alloy or tantalum markers as specified in ASTM F136, F560, F1295, and F2026. SUSTAIN® R TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580. {7}------------------------------------------------ # PATRIOT® Lumbar Spacers PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, TransContinental® TPS, TransContinental® M and TransContinental® M TPS) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. Constitution® PLIF Spacers are inserted using a posterior approach. Signature® TLIF Spacers are inserted using a transforaminal approach. Continental® ALIF Spacers are inserted using an anterior approach. Transcontinental® and TransContinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). Signature® R Spacers also include an internal titanium alloy or commercially pure titanium (ASTM F67) component, and TransContinental® M Spacers also include an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295). PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580. ## PATRIOT® Cervical Spacers PATRIOT® Spacers (including COLONIAL® and COLONIAL® TPS) are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. COLONIAL® ACDF Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560. PATRIOT® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580. # CALIBER® Spacers CALIBER® Spacers (including CALIBER® TPS) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. CALIBER® Spacers provide different shapes to accommodate various surgical approaches to the lumbar spine (posterior, {8}------------------------------------------------ transforaminal [posterolateral] or lateral). The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. CALIBER® Spacers are manufactured from radiolucent PEEK polymer and titanium alloy per ASTM F2026, F136 and F1295; non-expandable CALIBER® Spacers are manufactured from PEEK only. CALIBER® Spacers contain radiopaque titanium alloy or tantalum markers as specified in ASTM F136, F1295 and F560. CALIBER® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580. # COALITION® Spacers COALITION®Spacers (including COALITION®TPS) are stand-alone cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. COALITION® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacers are to be filled with autogenous bone graft material. COALITION® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium allov, as specified in ASTM F136 and F1295. COALITION® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580. # INDEPENDENCE® Spacers INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacers are to be filled with autogenous bone graft material. INDEPENDENCE® Spacers are made from radiolucent polymer, with titanium allov or tantalum markers, as specified in ASTM F2026. F136. F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available {9}------------------------------------------------ with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. INDEPENDENCE® TPS Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580. ## FORTIFY® Corpectomy Spacers FORTIFY® (including FORTIFY®-R and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY® Integrated endplates have an integrated plate to accommodate screws for additional fixation and are assembled to the core. FORTIFY® and FORTIFY® I-R Corpectomy Spacers are manufactured from titanium alloy per ASTM F136 and F1295. FORTIFY®-R, FORTIFY®-R TPS, FORTIFY® I-R, and FORTIFY® I-R TPS Corpectomy Spacers are manufactured from radiolucent PEEK polymer, with titanium alloy and tantalum components, per ASTM F2026, F136, F1295, and F560. Screws are manufactured from titanium alloy per ASTM F136 and F1295, with or without hydroxyapatite coating per ASTM F1185. FORTIFY® R TPS and FORTIFY® I-R TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580. # XPand® Corpectomy Spacers XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various heights and footprints to fit the anatomical needs of a wide variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The XPand® devices are made from titanium alloy as specified in F136 and F1295. The XPand®-R and XPand®R TPS Corpectomy Spacers are made from radiolucent polymer and titanium alloy as specified in ASTM F2026, F136 and F1295, and include markers made from titanium allov or tantalum as specified in ASTM F136, F1295 and F560. XPand®-R TPS Corpectomy Spacers also have a {10}------------------------------------------------ commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580. # NIKO® Corpectomy Spacers NIKO® Corpectomy Spacers (including NIKO® TPS) are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The system is comprised of spacers of various fixed heights to fit the anatomical needs of a variety of patients. Each spacer has an axial hole to allow grafting material to be packed inside the spacer. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. NIKO® Corpectomy Spacers are made from radiolucent polymer and titanium alloy or tantalum as specified in ASTM F2026, F136, F1295, and F560. NIKO® TPS Corpectomy Spacers also have a commercially pure titanium plasma spray coating, as specified in ASTM F67 and F1580. ### Indications for Use: # SUSTAIN® Spacers When used as lumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R and SUSTAIN® R TPS) are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO® REVERE® REVOLVE® or BEACON® Stabilization Systems. When used as cervical intervertebral body fusion devices, SUSTAIN® Spacers are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. SUSTAIN® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems. When used as vertebral body replacement devices, SUSTAIN® Spacers are intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior {11}------------------------------------------------ pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. SUSTAIN® Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. ## PATRIOT® Lumbar Spacers PATRIOT® Spacers (including Constitution®, Constitution® TPS, Signature®, Signature® TPS, Continental®, Continental® TPS, TransContinental®, TransContinental® TPS, TransContinental® M, and TransContinental® M TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation. # PATRIOT® Cervical Spacers PATRIOT® Spacers (including COLONIAL® and COLONIAL® TPS) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems. # CALIBER® Spacers CALIBER® Spacers (including CALIBER® TPS) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). CALIBER® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the CREO®, REVERE® or REVOLVE® Stabilization Systems. {12}------------------------------------------------ # COALITION® Spacers COALITION® Spacers (including COALITION® TPS) are stand-alone interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. COALITION® Spacers are to be filled with autogenous bone graft material, and are to be used with two titanium alloy screws which accompany the implants. # INDEPENDENCE® Spacers INDEPENDENCE® Spacers (including INDEPENDENCE® TPS) are stand-alone interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INDEPENDENCE® Spacers are to be filled with autogenous bone graft material, and are to be used with three titanium alloy screws, which accompany the implants. # FORTIFY® Corpectomy Spacers FORTIFY® (including FORTIFY®-R and FORTIFY®-R TPS) and FORTIFY® Integrated (including FORTIFY® I-R and FORTIFY® I-R TPS) Corpectorny Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. # XPand® Corpectomy Spacers XPand® Corpectomy Spacers (including XPand®-R and XPand®-R TPS) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). XPand® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate system, and anterior screw and rod systems). The interior of the spacer can be packed with bone grafting material. XPand® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. {13}------------------------------------------------ # NIKO® Corpectomy Spacers NIKO® Corpectomy Spacers (including NIKO® TPS) are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). NIKO® Corpectomy Spacers are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with bone grafting material. NIKO® Corpectomy Spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. ## Performance Data: Performance of TPS Spacers was evaluated in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007. Dynamic compression shear and dynamic torsion testing was performed per ASTM F2077. Coating characterization testing was conducted in accordance with the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." February 2, 2000, and ASTM F1044, F1147, F1160, F1854, and F1978, with additional wear analysis to demonstrate adequate coating of the implants. ## Basis of Substantial Equivalence: TPS Spacers have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices. TPS Spacers are as safe, as effective, and perform as well as or better than the predicate devices.
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%