When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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, and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint b) who are receiving fusions with autogenous graft only c) who are having the device fixed or attached to the lumbar or sacral spine d) who are having the device removed after the development of a solid fusion mass. When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette Spinal Fixation System are intended for sacral iliac attachment only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
Device Story
Temporary spinal implant system; provides immobilization/stabilization to facilitate biological spinal fusion. Components include polyaxial/fixed screws, rods, hooks, and transverse connectors. Used in thoracic, lumbar, and sacral spine. Implants are top-loading/top-tightening. Intended for removal after solid fusion. Surgeon-operated in clinical/surgical settings. Benefits patient by correcting spinal deformity and restoring stability. Mechanical performance validated via ASTM F1717-96 testing.
Clinical Evidence
Bench testing only. Mechanical testing performed according to ASTM F1717-96 to validate the mechanical properties of the Variable Angle Screw, connector, and Axial Connector compared to the predicate system.
Indicated for skeletally mature patients requiring spinal immobilization and stabilization as an adjunct to fusion. Conditions include degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, degenerative disc disease, and spinal stenosis. Levels of use: T1 to sacrum. Contraindications include patients not requiring fusion or those without skeletal maturity.
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.
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(020196
## FEB 1 5 2002
### 510(k) Summary
| Submitter: | Sulzer Spine-Tech<br>7375 Bush Lake Road<br>Minneapolis, Minnesota 55439 |
|------------------------------------------|--------------------------------------------------------------------------|
| Date Prepared: | January 18, 2001 |
| Contact: | Kristyn M. Benson<br>Regulatory Affairs Specialist |
| Proprietary Name: | Silhouette™ Spinal Fixation System |
| Common Name: | Rod, hook, and screw spinal instrumentation |
| Device Product Code<br>& Classification: | Class II; MNI, MNH, and KWP |
| Predicate Device: | Silhouette™ Spinal Fixation System<br>(K980288 & K992276) |
#### Device Description:
The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws arous of the epino. and are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths; fixed screws of varying diameters and lengths; rods in varying lengths; hooks in varying designs; and transverse connectors in the various noofigurations of fixed, adjustable, variable angle offset and axial. All implant components are either top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.
#### Intended Use:
Used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients:
- a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
- b) who are receiving fusions with autogenous graft only
- c) who are having the device fixed or attached to the lumbar or sacral spine
- d) who are having the device removed after the development of a solid fusion mass
Used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due
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to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and to turnors, opinal fusion. When used for this indication, screws of the provious Tallou "Spinal Fixation System are intended for sacral illiac attachment only. Olinouctic - Opinal Pixation System are intended for posterior thoracic Hook and transverse only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
## Statement of Technological Comparison:
Otatement of rooming carried out according to ASTM 1717-96 to validate the Mechaniour couling was camnector and the Axial Connector. The testing Vanable Anglo Show e mechanical properties to the previously cleared Silhouette™ Spinal Fixation System components.
84/2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes above two wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# FEB 1 5 2002
Ms. Kristyn M. Benson Regulatory Affairs Specialist Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K020196
Trade Name: Silhouette™ Spinal Fixation System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spondylolisthesis Spinal Fixation Device System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: January 18, 2002 Received: January 22, 2002
Dear Ms. Benson:
We have reviewed your Section 510(k) notification of intent to market the device we nave love and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce mineations for assosuled in actment date of the Medical Device Amendments, or to provision have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the Drug, and Controls provisions of the Act. The general controls provisions of the Act include general controls provisions of ration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major (I chiarket Approvar), wirder can be found in the Code of Federal Regulations, Title 11, Parts 800 to 895. A substantially equivalent determination assumes compliance with 21, Furth 600 to 090 Manufacturing Practice requirement, as set forth in the Quality System the current Sood Manazion Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory Such assumptions. FDA may publish further announcements concerning your device in action: 'In addition, I Dr. as note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
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### Page 2 - Ms. Kristyn M. Benson
for devices 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) I his letter will anow you to begin maineting your alence of your device to a
premarket notification. The FDA finding of substantial equivalence and thus premarket notification: "The I Dri mailing of cassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 II you desire specific advice 107 youdiagnostic devices), please contact the Office of and additionally 607.10 for in this exting are at the promotions on the promotion and Compliance at (301) 594-4657. Practionally, Office of Compliance at (301) 594-4639.
advertising of your device, please contact the Office of Compliance at (301) 994-4639. advertising of your device, prease titled, "Misbranding by reference to premarket Also, please note the regulation entition, "Misoniation on your responsibilities under nothication (21 CH 807.97): Other general Manufacturers Assistance at its tollthe Act may be obtains 2011 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Miriam C. Provost
for 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
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# INDICATIONS FOR USE STATEMENT
(Pending) KO20196 510(k) Number:
Silhouette™ Spinal Fixation System Device Name:
Indications for Use:
When used as a pedicle screw fixation system in skeletally mature patients, the When used as a pedicie screw in is intended to provide immobilization and Silhouette™ Spinal segments as an adjuct to fusion in the treatment of the following
stabilization of spinal segments as an adjunct to fusion in the teacher stabilization of spinal segments as an adjance to he thoracic, umbar, and sacral spine.
acute and chronic instabilities or deformities of the thoracy, pourcelogic, imagirment degenerative spondylolisthesis with objective evidence of neurologic impairment, degenerative spondylolistiesis with objective of nearly of the arguing fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation i System is indicated for use in patients:
- a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
- a) having over receiving fusions with autogenous graft only
- b) who are having the device fixed or attached to the lumbar or accral spine
- c) who are having the device fixed or underfou to and open of a solid fusion mass
When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is When used as a nook and Sacraf Sciew System, the Use disease (as defined by chronic intended for use in the treathern of degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolistics, kyphotic or lordobro frecture radiographic 'studies), "Idiopanic" societic," opens, spinal stenosis, vertebral fracture deformly of the spire, loss of stablity ado failed spinal fusion. When used for this or dislocation, pseudoannosis, and previous failor System are intended for sacal liliac
indication, screws of the Silhouette Spinal Fixation System are intended for indication, screws of the Silhodette Opthat Pixation System are intended for attachment only. Thook and transverov of the evels of use for hook and posterior thoracian of this system are T1 to the sacrum.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use రు (Per 21 CFR 801.109)
OR
Over-the-Counter-Use _________________________________________________________________________________________________________________________________________________________
Silhouette™ Spinal Fixation System Special 510(k) Notification
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Part 1 — Search, results, and everyday workflows 16 min
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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.
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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?
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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.
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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.
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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.
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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.
