← Product Code [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX) · K181655 # Renovis S180 Lateral Lumbar Interbody Fusion System (K181655) _Renovis Surgical Technologies · MAX · Sep 11, 2018 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K181655 ## Device Facts - **Applicant:** Renovis Surgical Technologies - **Product Code:** [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX.md) - **Decision Date:** Sep 11, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Renovis S180 Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have at least six months of non-operative treatment prior to treatment with the devices. The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis S180 System implants are to be used with autogenous bone graft. ## Device Story Renovis S180 Lateral Lumbar Interbody Fusion System consists of interbody fusion cages designed for lateral surgical approach. Implants are additively manufactured from Ti-6Al-4V using powder bed fusion. System includes various lengths, widths, heights, and lordotic configurations to match patient anatomy. Used by orthopedic surgeons in clinical settings for lumbar fusion procedures. Implants provide structural support to intervertebral space during fusion; must be used with supplemental fixation and autogenous bone graft. Device benefits patients by stabilizing spinal segments affected by degenerative disc disease, potentially reducing discogenic back pain. Performance verified through mechanical testing including dynamic axial compression, expulsion, static push-out, and tensile testing. ## Clinical Evidence Bench testing only. No clinical data provided. Mechanical testing included dynamic axial compression (ASTM F2077), expulsion/static push-out testing, and tensile testing (ASTM E8/E8M-15a). Sterilization and packaging validation performed per ISO and ASTM standards. ## Technological Characteristics Implants: Ti-6Al-4V (ASTM F2924) via additive manufacturing (powder bed fusion). Instruments: Stainless steel (ASTM F564) and Ti-6Al-4V (ASTM F136, ASTM F1472). Features porous surface structure. Gamma sterilized. Dimensions vary by patient anatomy. No software or electronic components. ## 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 - Renovis S141 Lumbar Interbody Fusion System ([K170888](/device/K170888.md)) - Renovis S128 Anterior Lumbar Interbody Fusion System ([K131122](/device/K131122.md)) - Renovis S128 Anterior Lumbar Interbody Fusion System ([K140106](/device/K140106.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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 11, 2018 Renovis Surgical Technologies % Ms. Sharyn Orton Senior Consultant MEDIcept, Inc. 200 Homer Ave Ashland. Massachusetts 01721 Re: K181655 Trade/Device Name: Renovis S180 Lateral Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 9, 2018 Received: July 10, 2018 Dear Dr. Orton: 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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Melissa Hall -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) K181655 #### Device Name Renovis S180 Lateral Lumbar Interbody Fusion System Indications for Use (Describe) The Renovis S180 Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have at least six months of non-operative treatment with the devices. The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis S180 System implants are to be used with autogenous bone graft. | 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) ### 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "RENOVIS" in red font. To the left of the word is a gray symbol that looks like three curved ribbons intertwined. The ribbons are shaded to give them a three-dimensional appearance. The word "RENOVIS" is in all capital letters. ### Traditional 510(k) Summary as required by 21 CFR 807.92(a) K181655 A ) Submitted by: Renovis Surgical Technologies 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374 Phone: 909-557-2360 Fax: 909-307-8571 Official Contact: Anthony DeBenedictis Vice President of Quality Assurance - Consultant: Sharyn Orton, Ph.D. MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721 - B) Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar Common Name: Intervertebral body fusion device Proprietary Name: Renovis S180 Lateral Lumbar Interbody Fusion System Device Class: Class II Regulations 21 CFR 888.3080 and Product Code: MAX Classification panel: Orthopedic - C) Predicates: - Primary: K170888 Renovis S141 Lumbar Interbody Fusion System ● - K131122 Renovis S128 Anterior Lumbar Interbody Fusion System ● - K140106 Renovis S128 Anterior Lumbar Interbody Fusion System ● D) Date Prepared: September 10, 2018 E) Device Description: The Renovis S180 Lateral Lumbar Interbody System is an additional offering to the Renovis system of interbody fusion devices. {4}------------------------------------------------ This application describes changes in lengths, widths, heights and lordosis configurations; material standard; packaging; and additive manufacturing device. The S180 LLIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for a lateral surgical approach for insertion. The S180 LLIF System cages are manufactured from Ti6A14V compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion. The system also includes instruments which are manufactured from: - Stainless steel in compliance with: ● - 0 ASTM F564/A564M 13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes - Ti-6Al-4V in compliance with: ● - O ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications - ASTM F1472-14 Standard Specification for Wrought Titanium-6Aluminumo 4 Vanadium Alloy for Surgical Implant Applications F) Intended Use/Indications For Use: The Renovis S180 Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have at least six months of non-operative treatment prior to treatment with the devices. The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis S180 System implants are to be used with autogenous bone graft. G) Substantial Equivalence Comparison and Discussion The S180 cages have the same clinical Indications for Use, are functionally the same, have a porous structure applied to the superior and inferior surface area, are additively manufactured from Ti-6Al-4V, and are gamma sterilized like the predicate devices. The S180 cages include different heights, widths, lengths and lordosis; and a change to the additive manufacturing machine. The manufacturing change was validated. {5}------------------------------------------------ The S180 LLIF System cages are substantially equivalent to the predicate devices. H) Performance Testing - Bench Successful mechanical/functional testing of the new worst-case S180 LLIF cages was conducted as follows: - Dynamic axial compression testing in accordance with ASTM F2077 . - . Expulsion, static push-out, testing - Mechanical Tensile Testing per ASTM E8/E8M-15a methods ● Sterilization validation was conducted. I) Compliance with Standards or FDA Guidance The Renovis S180 LLIF System cages comply with the following: - · ISO 11607-2:2006 Packaging for Terminally Sterilized Medical Devices Part 2: Validation requirements for forming, sealing and assembly processes - · ISTA 2A:2011 Packaged-products weighing 150 lbs. (68kg) or less - · ASTM D4169:2016 Standard Practice for Performance Testing of Shipping Containers and Systems - · ASTM E8/E8M-15a Standard Test Methods for Tension Testing of Metallic Materials - · ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion - ASTM F1044-05 (R)2017e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings - ASTM F1147-05 (R)2017e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings - · ASTM F1160-14 (R)2017e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings - · ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants - · ASTM F1978-17 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser - · ASTM F2077-17 Test methods for intervertebral body fusion devices - · AAMI/ANSI ST72:2011 Bacterial endotoxins test methods, routine monitoring, and alternatives to batch testing o Same as AAMI/ANSI ST72:2011(R)2016 - · AAMI/ANSI/ISO 10993-1:2009(R)2013 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process - AAMI/ANSI/ISO 10993-5:2009(R)2014 Biologic Evaluation Of Medical Devices Part 5: Tests For In Vitro Cytotoxicity - · AAMI/ANSI/ISO 11137-2:2013 Sterilization of health care products radiation part 2: establishing the sterilization dose {6}------------------------------------------------ - · AAMI/ANSI/ISO 11737-1:2006 R(2011)Sterilization of health care products microbiological methods - part 1: determination of the population of microorganisms on product - · ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of Orthopedic Implants and Instruments - ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components - · Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 2007 - · Guidance for Industry and FDA Staff Technical Considerations for Additive Manufactured Medical Devices, December 2017 - · Guidance for Industry and FDA Staff Reporting of Computational Modeling Studies in Medical Device Submissions, September 2016 ## Conclusion There are no different issues of safety or effectiveness associated with the S180 LLIF System cages. Testing, where applicable, was conducted found to be acceptable. The S180 LLIF System cages are substantially equivalent to the predicate devices and are expected to perform per their intended use. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K181655](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K181655) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com