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.
Indications for Use
Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with discogenic back pain, including up to Grade 1 spondylolisthesis or retrolisthesis. Requires 6 months of prior non-operative treatment.
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
Renovis S134 Anterior Lumbar Interbody Fusion (ALIF) System (K142095)
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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
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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
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# 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)
| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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### 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<br>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<br>predicate devices | Primary predicate: Renovis S134 Anterior Lumbar Interbody Fusion (ALIF)<br>System manufactured by Renovis Surgical Technologies, Inc (K142095)<br>Additional predicates: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II,<br>MIDLINE II-Ti manufactured by Centinel Spine, Inc (K150643), VU APOD<br>Intervertebral Body Fusion Device Manufactured by Theken Spine, LLC<br>(K101310, K121211) and Juliet® Ti manufactured by Spineart (K153621) |
| Indications for use | The Scarlet® AL-T system is indicated for intervertebral body fusion procedures<br>in skeletally mature patients with degenerative disc disease (DDD) of the<br>lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as<br>discogenic back pain with degeneration of the disc confirmed by patient history<br>and radiographic studies. These DDD patients may also have up to Grade 1<br>spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants<br>are to be used with autogenous and/or allogeneic bone graft comprised of<br>cancellous and/or corticocancellous bone graft to facilitate fusion. Patients<br>should have at least six (6) months of non-operative treatment prior to<br>treatment with an intervertebral cage.<br>When used with the integrated fixation by the mean of the bone screws<br>provided, the Scarlet® AL-T is a stand-alone system and requires no additional<br>supplemental fixation system.<br>When used as a lumbar intervertebral fusion device (i.e. without the bone<br>screws provided), the Scarlet® AL-T interbody device must be used with<br>supplemental internal spinal fixation system that has been cleared by the FDA<br>for use in the lumbosacral spine. |
| Description of the device | The Scarlet® AL-T spinal system is an anterior lumbar interbody fusion device<br>with integrated fixation intended to provide mechanical support to the lumbar<br>spine and maintain adequate disc space until fusion occurs. The Scarlet® AL-T<br>system comprises a range of intervertebral spacers implanted via an anterior<br>approach, and having various sizes, heights, footprints and lordosis so as to<br>adapt individual pathology and different patient's anatomical conditions. The<br>interbody device is a box-shaped spacer with a large central cavity that can<br>receive bone graft intended to promote intervertebral fusion. The Scarlet® AL-<br>T spacers are all made from medical grade titanium alloy conforming to ASTM<br>F136 standard and are produced by additive manufacturing (SLM) according to<br>ASTM F3001. Subsequently the spacer is machined (thread tapping) and<br>polished.<br>The Scarlet® AL-T interbody spacer has a monolithic design that incorporates<br>solid, lattice and porous structures along with superior and inferior rough<br>surfaces intended to increase implant stability into the intervertebral space and<br>bony integration throughout the implant.<br>When used as a stand-alone system with its integrated fixation, the spacer is<br>crossed by three (3) bone screws protruding into the vertebral endplates. The<br>bone screws are secured by the mean of two (2) cam locks that prevent backing<br>out.<br>The Scarlet® AL-T spinal implants are delivered sterile (gamma sterilization) and<br>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<br>technology, i.e. additive manufacturing (SLM) as predicate device Juliet® Ti<br>(K153621). The characterization of the chemical, physical and mechanical<br>properties of the material was performed in accordance with ASTM F3001 and<br>the ASTM E8/E8M. The porous structure featured on titanium alloy implants<br>additively manufactured was validated based on the FDA's Guidance for<br>industry on the testing of metallic plasma sprayed coatings on orthopedic<br>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<br>dynamic axial compression (per ASTM F2077-17), Static and dynamic Shear<br>compression (per ASTM F2077-17) expulsion (per ASTM Draft F-04.25.02.02)<br>and subsidence (per ASTM F2267-04). Results demonstrate comparable<br>mechanical properties to the predicate devices.<br>Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity<br>testing to achieve the Endotoxin limit of 20 EU / device. |
| Conclusion | Based on the design features, technological characteristics, feature<br>comparisons, indications for use, and non-clinical performance testing, the<br>Scarlet® AL-T has demonstrated substantial equivalence to the identified<br>predicate devices. |
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
