← Product Code [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD) · K191581 # Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (K191581) _Titan Spine, Inc. · OVD · Jan 8, 2020 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K191581 ## Device Facts - **Applicant:** Titan Spine, Inc. - **Product Code:** [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD.md) - **Decision Date:** Jan 8, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The ENDOSKELETON® TL Interbody Fusion Device is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The ENDOSKELETON® TL Hyperlordotic Interbody Fusion Device (≥ 16°) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the ENDOSKELETON® TL Hyperlordotic Interbody Fusion Device. Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. The Interbody Device is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft bone marrow aspirate, or a combination thereof. The ENDOSKELETON® TL Hyperlordotic Interbody Fusion Devicemust be used with an integrated Lateral Plate and Bone Screw and additionally must be used with posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine. ## Device Story Titanium alloy interbody fusion implants for lateral lumbar interbody fusion; hollow center for bone graft (autograft/allograft/demineralized bone matrix); superior/inferior surfaces feature nanoLOCK® or Chemtex® surface treatments to enhance bone fixation. Hyperlordotic versions (≥ 16°) include integrated lateral plate and bone screws with locking cover to prevent screw back-out. Implants placed by surgeons in clinical settings; used with supplemental posterior internal fixation. Device provides structural support and facilitates fusion via bone ingrowth through internal windows. Benefits include stabilization of disc space and promotion of long-term fusion in DDD patients. ## Clinical Evidence Bench testing only. Performed static and dynamic testing per ASTM F2077-18 and ASTM F2267-04(R18). Bone screw configurations tested per ASTM F543-17. Particulate and wear analysis conducted per ASTM F1877-16. Bacterial endotoxin testing (LAL) performed. ## Technological Characteristics Materials: ASTM F136 or ASTM F3001 Ti6Al4V ELI titanium alloy. Surface: nanoLOCK® or Chemtex® microscopic roughened surface. Form factor: Interbody spacers with hollow centers and windows; hyperlordotic models include integrated lateral plate and bone screws with locking cover. Sterilization: Provided sterile. ## Regulatory 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 - Titan Spine Endoskeleton® TAS / TASH ([K163269](/device/K163269.md)) - Endoskeleton® TL Interbody Fusion Device ([K140055](/device/K140055.md)) - Endoskeleton® TO Interbody Fusion Device ([K170399](/device/K170399.md)) - Endoskeleton® TA Interbody Fusion Device ([K080615](/device/K080615.md)) - Surgicraft STAFLIF TT ([K073109](/device/K073109.md)) - Endoskeleton® Interbody Fusion Devices ([K192018](/device/K192018.md)) ## Reference Devices - Titan Spine Allograft indications update ([K183557](/device/K183557.md)) - Titan Spine Sterile TAS / TCS screws ([K173535](/device/K173535.md)) - Titan Spine sterile only ([K142589](/device/K142589.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 8, 2020 Titan Spine, Inc. % Christine Scifert Exec VP MRC/X, LLC 6075 Poplar Avenue Memphis. Tennessee 38119 Re: K191581 Trade/Device Name: Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TL Hyperlordotic Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: December 6, 2019 Received: December 11, 2019 Dear Christine Scifert: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Brent L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191581 ## Device Name Endoskeleton® TL Interbody Fusion Device Endoskeleton® TL Hyperlordotic Interbody Fusion Device #### Indications for Use (Describe) The ENDOSKELETON® TL Interbody Fusion Device is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate. The ENDOSKELETON® TL Hyperlordotic Interbody Fusion Device (≥ 16°) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the ENDOSKELETON® TL Hyperlordotic Interbody Fusion Device. Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. The Interbody Device is indicated to be used with autograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft bone marrow aspirate, or a combination thereof. The ENDOSKELETON® TL Hyperlordotic Interbody Fusion Devicemust be used with an integrated Lateral Plate and Bone Screw and additionally must be used with posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------|-------------------------------------------------------------------------------| |
Prescription Use (Part 21 CFR 801 Subpart D)
|
Over-The-Counter Use (21 CFR 801 Subpart C)
| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ # 510(k) Summary # Endoskeleton® TL Interbody Fusion Device Endoskeleton® TL Hyperlordotic Interbody Fusion Device January 7, 2020 | Company: | Titan Spine, Inc.
6140 West Executive Drive, Suite A
Mequon, WI 53092, USA | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration: | 3006340236 | | Primary Contact: | Christine Scifert
Phone: 901-831-8053 | | Company Contact: | Kelly McDonnell
Phone: 866-822-7800
Fax: 262-242-7802 | | Trade Name: | Endoskeleton® TL Interbody Fusion Device
Endoskeleton® TL Hyperlordotic Interbody Fusion Device | | Common Name: | Intervertebral Body Fusion Device with Bone Graft, Lumbar
Intervertebral Fusion Device With Integrated Fixation, Lumbar | | Classification: | Class II | | Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) | | Panel: | 87- Orthopedic | | Product Code: | MAX, OVD | | Predicate Devices: | Primary Predicate:
Titan Spine Endoskeleton® TAS / TASH – K163269

Secondary Predicates:
Endoskeleton® TL Interbody Fusion Device – K140055
Endoskeleton® TO Interbody Fusion Device – K170399
Endoskeleton® TA Interbody Fusion Device – K080615
Surgicraft STAFLIF TT – K073109
Endoskeleton® Interbody Fusion Devices - K192018

Reference Predicates:
Titan Spine Allograft Indications update - K183557
Titan Spine Sterile TAS / TCS screws – K173535 | {4}------------------------------------------------ #### Device Description: The ENDOSKELETON® TL Interbody Fusion Device implants are available in a variety of lengths, widths, and heights for treatment in Lateral Lumbar Interbody Fusion and are designed with a large hollow region in the center to house autograft bone or allograft bone comprised of cancellous and/ or corticocancellous bone, demineralized allograft bone marrow aspirate, or a combination thereof. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of device placement and over time formation of new bone. The superior and inferior surfaces include either the Chemtex® surface treatment or nanoLOCK® surface treatment (MMN™) designed to improve fixation to the adjacent bone. The nanoLOCK® surface technology (MMN™) provides a microscopic roughened surface with nano-scale features. The implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and provided either sterile. An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant inserter and to facilitate placement of the implant into the interbody space. The subject submission introduces the ENDOSKELETON® TL Hyperlordotic Interbody Fusion Devices are available in a variety of lengths, widths, and heights for treatment in Lateral Lumbar Interbody Fusion and are designed with a large hollow region in the center to house autograft bone comprised of cancellous and/or corticocancellous bone. The design incorporates "windows" through the Interbody Device to permit visualization of the Interbody Device placement and over time formation of new bone. The new bone formation through the Interbody Device is intended to provide long-term structural support and fusion at the implanted disc space. The Interbody Device is treated with nanoLOCK® Surface Technology (MMN™) designed to improve fixation to the adjacent bone. The nanoLOCK® Surface Technology (MMN™) provides a microscopic roughened surface with nano-scale features. The subject submission also includes Lateral Plate and Bone Screws which are available in a variety of sizes for stabilizing the Interbody Device. The Lateral Plate has one or two hole(s) for receiving integrated Bone Screws and a feature for attachment to the Interbody Device. The Lateral Plate incorporates a lock cover to resist the integrated Bone Screws from backing out. Holding features have been incorporated into the Interbody Device and associated device components to facilitate placement of the system into the interbody space. The Interbody Device and associated device components are composed of ASTM F136 or ASTM F3001 Ti6Al4V ELI titanium alloy and provided sterile. #### Indication for Use: The ENDOSKELETON® TL Interbody Fusion Device is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft {5}------------------------------------------------ bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. The ENDOSKELETON® TL Hyperlordotic Interbody Fusion Device (≥ 16") is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the ENDOSKELETON® TL Hyperlordotic Interbody Fusion Device. Patients with previous non-fusion spinal surgery at the involved level(s) may be treated with the device. The Interbody Device is indicated to be used with autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft bone marrow aspirate, or a combination thereof. The ENDOSKELETON® TL Hyperlordotic Interbody Fusion Devicemust be used with an integrated Lateral Plate and Bone Screw and additionally must be used with posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine. ### Substantial Equivalence: Primary predicate Endoskeleton TAS / TAS Hyperlordotic (K163269), Secondary predicates including Endoskeleton TL (K140055), Endoskeleton TO (K170399), Endoskeleton TA (K080615), Endoskeleton® Interbody Fusion Devices (K192018) and Centinel Spine / Surgicraft STAFLIF TT (K073109) and Reference predicates include Titan Spine Allograft indications update (K183557), Titan Spine sterile TAS/ TCS screws (K173535), and Titan Spine sterile only (K142589). The subject devices share similar indications for use, geometry, material, manufacturing processes and construction with the predicate devices. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness. ### Performance Testing: The subject Endoskeleton® TL and TL Hyperlordotic device constructs underwent static and dynamic testing in accordance with ASTM F2077-18 and ASTM F2267-04(R18), where testing was performed on the worst-case construct. The worst-case bone screw configurations were additionally tested per ASTM F543-17. Particulate and wear analysis on dynamically loaded specimens was conducted per ASTM F1877-16. Bacterial endotoxin testing (LAL) was conducted for these devices. ### Conclusion: Based upon the information contained in this submission and the similarities of the subject and predicate devices, the subject Endoskeleton® TL Interbody Fusion Device and Endoskeleton® TL Hyperlordotic Fusion Devices are substantially equivalent to the predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K191581](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K191581) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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