← Product Code [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD) · K181818 # Scarlet AL-T (K181818) _Spineart · OVD · Oct 9, 2018 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K181818 ## Device Facts - **Applicant:** Spineart - **Product Code:** [OVD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD.md) - **Decision Date:** Oct 9, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Scarlet® AL-T 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. 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 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. When used with the integrated fixation by the mean of the bone screws provided, the Scarlet® AL-T is a stand-alone system and requires no additional supplemental fixation system. When used as a lumbar intervertebral fusion device (i.e. without the bone screws provided), the Scarlet® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine. ## Device Story Scarlet® AL-T is an anterior lumbar interbody fusion (ALIF) device providing mechanical support to the lumbar spine to facilitate fusion. The system consists of box-shaped titanium alloy spacers with a central cavity for bone graft, implanted via an anterior approach. The device features a monolithic design with solid, lattice, and porous structures to promote bony integration. When used as a stand-alone system, three bone screws are inserted through the spacer into vertebral endplates and secured with two cam locks to prevent back-out. The device is used in a surgical setting by a surgeon. It provides immediate mechanical stability and maintains disc space height, potentially benefiting patients by alleviating discogenic pain through successful spinal fusion. ## Clinical Evidence Bench testing only. No clinical data provided. Mechanical testing included static and dynamic axial compression (ASTM F2077-17), static and dynamic shear compression (ASTM F2077-17), expulsion (ASTM Draft F-04.25.02.02), and subsidence (ASTM F2267-04). Bacterial endotoxin testing performed per USP standards. ## Technological Characteristics Material: Medical grade titanium alloy (ASTM F136). Manufacturing: Additive manufacturing (SLM) per ASTM F3001, followed by machining and polishing. Design: Monolithic, box-shaped spacer with solid, lattice, and porous structures. Fixation: Integrated bone screws with cam locks. Sterilization: Gamma radiation. Connectivity: None. ## 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 S134 Anterior Lumbar Interbody Fusion (ALIF) System ([K142095](/device/K142095.md)) - Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti ([K150643](/device/K150643.md)) - VU APOD Intervertebral Body Fusion Device ([K101310](/device/K101310.md), [K121211](/device/K121211.md)) - Juliet® Ti ([K153621](/device/K153621.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}------------------------------------------------ October 9, 2018 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Spineart Franck Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 Plan Les Ouates Geneva. Switzerland Re: K181818 Trade/Device Name: Scarlet® AL-T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: September 12, 2018 Received: September 13, 2018 Dear Franck Pennesi: 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 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. Brent Showalter -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) K181818 Device Name Scarlet® AL-T #### Indications for Use (Describe) The Scarlet® AL-T 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. 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 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. When used with the integrated fixation by the mean of the bone screws provided, the Scarlet® AL-T is a stand-alone system and requires no additional supplemental fixation system. When used as a lumbar intervertebral fi.e. without the bone screws provided), the Scarlet® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral 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}------------------------------------------------ ### Traditional 510k SCARLET® AL-T ## 510(k) SUMMARY | 510k | TRADITIONAL | |-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Basis for submission | NEW DEVICES | | Submitted by | SPINEART | | | 3 Chemin du Pré Fleuri | | | 1228 PLAN LES OUATES
GENEVA SWITZERLAND | | Contacts | Franck PENNESI Chief Technical Officer | | | Phone : +41 22 570 1200 Fax : +41 22 594 8306 | | | Mail: fpennesi@spineart.com | | | Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr | | Date Prepared | July 2, 2018 | | Common Name | Intervertebral body fusion device | | Trade Name | Scarlet® AL-T | | | Intervertebral Fusion Device with Integrated Fixation Lumbar / Intervertebral | | Classification Name | Fusion Device Lumbar | | Class | II | | Product Code | OVD / MAX | | CFR section | 888.3080 | | Device panel | ORTHOPEDIC | | Legally marketed
predicate devices | Primary predicate: Renovis S134 Anterior Lumbar Interbody Fusion (ALIF)
System manufactured by Renovis Surgical Technologies, Inc (K142095)
Additional predicates: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II,
MIDLINE II-Ti manufactured by Centinel Spine, Inc (K150643), VU APOD
Intervertebral Body Fusion Device Manufactured by Theken Spine, LLC
(K101310, K121211) and Juliet® Ti manufactured by Spineart (K153621) | | Indications for use | The Scarlet® AL-T 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. 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 1
spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants
are to be used with autogenous and/or allogeneic bone graft comprised of
cancellous and/or corticocancellous bone graft to facilitate fusion. Patients
should have at least six (6) months of non-operative treatment prior to
treatment with an intervertebral cage.
When used with the integrated fixation by the mean of the bone screws
provided, the Scarlet® AL-T is a stand-alone system and requires no additional
supplemental fixation system.
When used as a lumbar intervertebral fusion device (i.e. without the bone
screws provided), the Scarlet® AL-T interbody device must be used with
supplemental internal spinal fixation system that has been cleared by the FDA
for use in the lumbosacral spine. | | Description of the device | The Scarlet® AL-T spinal system is an anterior lumbar interbody fusion device
with integrated fixation intended to provide mechanical support to the lumbar
spine and maintain adequate disc space until fusion occurs. The Scarlet® AL-T
system comprises a range of intervertebral spacers implanted via an anterior
approach, and having various sizes, heights, footprints and lordosis so as to
adapt individual pathology and different patient's anatomical conditions. The
interbody device is a box-shaped spacer with a large central cavity that can
receive bone graft intended to promote intervertebral fusion. The Scarlet® AL-
T spacers are all made from medical grade titanium alloy conforming to ASTM
F136 standard and are produced by additive manufacturing (SLM) according to
ASTM F3001. Subsequently the spacer is machined (thread tapping) and
polished.
The Scarlet® AL-T interbody spacer has a monolithic design that incorporates
solid, lattice and porous structures along with superior and inferior rough
surfaces intended to increase implant stability into the intervertebral space and
bony integration throughout the implant.
When used as a stand-alone system with its integrated fixation, the spacer is
crossed by three (3) bone screws protruding into the vertebral endplates. The
bone screws are secured by the mean of two (2) cam locks that prevent backing
out.
The Scarlet® AL-T spinal implants are delivered sterile (gamma sterilization) and
supplied with dedicated surgical instruments (reusable - provided non-sterile). | | Technological characteristics compared to predicate devices | The Scarlet® AL-T implants are manufactured using the same manufacturing
technology, i.e. additive manufacturing (SLM) as predicate device Juliet® Ti
(K153621). The characterization of the chemical, physical and mechanical
properties of the material was performed in accordance with ASTM F3001 and
the ASTM E8/E8M. The porous structure featured on titanium alloy implants
additively manufactured was validated based on the FDA's Guidance for
industry on the testing of metallic plasma sprayed coatings on orthopedic
implants to support reconsideration of postmarket surveillance requirements. | | Discussion of Testing | The following non-clinical tests were conducted on the Scarlet® AL-T: Static and
dynamic axial compression (per ASTM F2077-17), Static and dynamic Shear
compression (per ASTM F2077-17) expulsion (per ASTM Draft F-04.25.02.02)
and subsidence (per ASTM F2267-04). Results demonstrate comparable
mechanical properties to the predicate devices.
Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity
testing to achieve the Endotoxin limit of 20 EU / device. | | Conclusion | Based on the design features, technological characteristics, feature
comparisons, indications for use, and non-clinical performance testing, the
Scarlet® AL-T has demonstrated substantial equivalence to the identified
predicate devices. | {4}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K181818](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OVD/K181818) **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