When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis). When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis). When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass. Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).
Device Story
SCS Claris Spinal Screws are orthopedic implants designed for spinal stabilization and immobilization. Screws are implanted by surgeons during spinal fusion procedures to provide structural support to the thoracic, lumbar, and sacral spine. The device acts as an adjunct to fusion, stabilizing spinal segments to facilitate bone healing. The screws are available in various diameters and lengths to accommodate patient anatomy. By providing rigid fixation, the device helps correct instabilities or deformities, potentially reducing pain and improving patient outcomes in cases of degenerative disease, trauma, or tumor-related instability. The device is intended for removal after solid fusion is achieved.
Clinical Evidence
No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons.
Technological Characteristics
Manufactured from stainless steel (ASTM F136 / ISO 5832-1) and titanium alloy (ASTM F138 / ISO 5832-3). Available in outer diameters 5.5-9.5mm and cancellous lengths 25-55mm.
Indications for Use
Indicated for patients with degenerative disc disease, spondylolisthesis, fractures, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumors, or pseudarthrosis. Posterior pedicle use restricted to skeletally mature patients (L3 and below) with severe spondylolisthesis (Grades 3-4 at L5-S1) requiring autogenous bone graft fusion.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
Predicate Devices
SCS Claris Spinal Screws Types V, L and R
Submission Summary (Full Text)
{0}------------------------------------------------
# AUG - 7 2001
## 510(k) SUMMARY of Safety and Effectiveness
| Sponsor: | OrthoTec, LLC<br>9595 Wilshire Blvd. Suite 502<br>Beverly Hills, CA 90212<br>Phone: (310) 557-2000 & (310) 273-1500<br>Fax: (310) 843-9500 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Bertranou, MD |
| Proprietary Trade Name: | SCS Claris Spinal Screws Types V, G and E |
| Device Description: | The SCS Claris Spinal Screws Types V, G and E are available in outer (major) diameters ranging from 5.5 to 9.5mm in 1mm increments and cancellous lengths ranging from 25 to 55mm in 5mm increments. |
| Intended Use: | When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis). |
| | When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis) |
| | When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass. |
| | Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis). |
| Materials: | The SCS Claris Spinal Screws are manufactured from stainless steel (ASTM F136 / ISO 5832-1) and titanium alloy (ASTM F138 / ISO 5832-3). |
| Substantial Equivalence: | Documentation was provided which demonstrated the SCS Claris Spinal Screws Types V, G and E to be substantially equivalent to the previously cleared SCS Claris Spinal Screws Types V, L and R. the substantial equivalence is based upon equivalence in indications/intended use, manufacturing methods, interconnection (attachment) mechanism, basic design and materials. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized bird-like symbol with three curved lines representing wings or feathers. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
AUG - 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Patrick Bertranou President OrthoTec, LLC 9595 Wilshire Boulevard, Suite 502 Beverly Hills, California 90212
Re: K011807 Trade Name: SCS Claris Spinal Screws Types V, G and E Regulatory Class: II Regulatory Class: 11
Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050, 21 CFR 888.3060 Product Code: MNI, MNH, KWP, KWQ Dated: July 23, 2001 Received: July 25, 2001
Dear Mr. Bertranou:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Security from total is substantially equivalent (for the indications for uses and above and we have determined the devices marketed in interstate commerce prior to May 28, 1976, the stated in the encrossure) to device Amendments, or to devices that have been reclassified in enactment date of the Medical Device Trinendments, or and Cosmetic Act (Act). You may,
accordance with the provisions of the Federal Food, Drug, and Cosment of the Asst. The accordance will the provisions of the reachar root controls provisions of the Act. The general therefore, market the device, subject to the generats for annual registration, listing of devices, controls provisions of the Act mende requirentibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into such additional controls. Existing major regulations
(Premarket Approval), it may be subject to such additional controls. Title (Premarket Approval), it may of subject to case of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good 895. A substainanty cquirement, as set forth in the Quality System Regulation (OS) for Manufacturing I ractice requirements as a 3 cc 820) and that, through periodic (QS) Medical Devices. General regulation (FDA) will verify such assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify such assumplia inspections, the Food and Drug Administration (1 Disy Internation . In addition, FDA may publish Comply with the GMT Tegalation may researce in the Federal Register. Please note: this further alliouncements concerning your consission does not affect any obligation you might response to your premarker nonnoution such success under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to begin marketing your device of your device to a legally marketed notheation. The I Dri miding of basianter open device and thus, permits your device to proceed to the market.
{2}------------------------------------------------
Page 2 - Mr. Patrick Bertranou
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Molluscuton
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
### Indications for Use Statement
510(k) Number (if known):
#### Device Name: SCS Claris Spinal Sustem Screws
Indications for Use:
#### When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudarthrosis)
#### When used as an anterolateral/anterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudarthrosis)
#### When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are:
having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint
receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine
having the device removed after the development of a solid fusion mass.
Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)
#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
,
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Bmithelenko than
and Neurological De
510(k) Number K011807
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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.
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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.
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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
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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.
