The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior. noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Device Story
Posterior spinal fixation system comprising cannulated pedicle screws, rods, set screws, and transverse linking mechanisms. Used in clinical settings by surgeons for spinal stabilization. Screws allow sagittal and coronal plane adjustment for optimal anatomical placement. Housing component secures rod and screw head via set screw tightening. Input: surgical site anatomy; Output: rigid spinal construct. Benefits: provides unilateral/bilateral fixation to facilitate fusion in patients with degenerative or traumatic spinal conditions.
Clinical Evidence
Bench testing only. No clinical data presented. Testing included static compression, static torsion, static tension, and dynamic compression per ASTM F1717-04.
Technological Characteristics
Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 for screws; Co-Cr-Mo for rods; surgical grade stainless steel for instruments. Design: Top-loading posterior spinal fixation system with cannulated screws. Connectivity: N/A. Sterilization: Not specified.
Indications for Use
Indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft/allograft. Conditions: degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, failed previous 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.
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JAN 2 5 2013
## 510(k) Summary
Company:
Medyssey Co. Ltd. 722-3, 4F, Science Tower 4F Donaducheon City Gyeonggido, Korea Tel: 82-31-879-0414 FAX: 82-31-879-0415
Contact:
Michael Kvitnitsky Chief Operating Officer Medyssey Co. Ltd 8001 N. Lincoln Ave. Suite 401 Skokie, IL 60077 Tel: 847-982-0100 FAX: 888-518-9070
Date Prepared: August 9, 2010
Proprietary Name: Iliad Pedicle Screws (formerly Novel) Kora Pedicle Screws (formerly Novel Standard Buttress Thread Screw) Zenius Pedicle Screws Cobalt Chrome Rods
Device Class: Class III
Product Codes: MNI, MNH, NKB
Classification Name: Noncervical, Pedicle Screw System
21 CFR 888.3070 Regulation Number:
Medyssey Co. Ltd, Zenius TM Spinal System K103272 and K110283; the Predicate Device: Medyssey Novel Spinal System K081153, K103147, and K110284; the Synthes Matrix Spine System K092929, K100634 and K100952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K100788; and the Aesculap S MIS Cannulated Pedicle Screw System (K100623, K090657, K071945, K062085 and K032219)
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Product Description:
The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with their respective (e.g. Zenius) top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Cannulated Pedicle Screw implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The Medyssey Co. Ltd., Cannulated Pedicle Screws can be used in the posterior plane providing unilateral and bilateral modes of fixation.
The Medyssey Co. Ltd., Cannulated Pedicle Screw Spinal design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a mobile and non-mobile housing component which
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houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod.
The Cobalt Chrome Rods are for use with the Zenius or Iliad System.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd. Cannulated Pedicle Screw implants.
### Indications for Use:
The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior. noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
#### Summary of Technological Characteristics Illiad System:
The Medyssey Illiad (formerly Novel) Cannulated Pedicle Screws consists of titaninum pedicie screws and rods. These screws are used with locking screws and instruments from the Illiad (formerly Novel System). Both the predicate and proposed pedicle screws are made from titanium. The proposed screw designs are the same as the current screw designs the only difference is the cannulation of the screws. The proposed rods are manufactured from Co-Cr-Mo; whereas, the predicate rods are manufactured from titanium allov. There are no other differences between the proposed and predicate rods.
Medyssey has determined that the minor differences between proposed screws and rods to the predicate devices will not impact the safety or effectiveness of the pedicle screw systems for their intended use. Analysis has shown that the proposed screws and rods are equivalent to the predicate devices.
#### Summary of Technological Characteristics Zenius System:
The Medyssev Zenuis Cannulated Pedicle Screws consists of a series of titanium pedicle screws and rods. These screws are used with locking screws and instruments from the Zenius System. Both the predicate and proposed pedicle screws are made from titanium. The proposed screw designs are the same as the current screw designs the only difference is the cannulation of the screws. The proposed rods are manufactured from Co-Cr-Mo; whereas, the predicate rods are manufactured from titanium alloy. There are no other differences between the proposed and predicate rods.
Medyssey has determined that the minor differences between proposed screws and rods to the predicate devices will not impact the safety or effectiveness of the pedicle screw systems for their intended use. Analysis has shown that the proposed screws and rods are equivalent to the predicate devices.
#### Summary of Technological Characteristics Kora System:
The Medyssev Kora (formerly Novel Standard Buttress Screw) Cannulated Pedicle Screws consists of a series of titaninum pedicle screws and rods. These screws are used with locking screws and instruments from the Kora System (formerly Novel Standard Buttress Screw. Both the predicate and proposed pedicle screws are made from titanium. The proposed screw designs are the current screw designs the only difference is the cannulation of the screws. The proposed rods are manufactured from Co-Cr-Mo: whereas, the predicate rods are manufactured from titanium alloy. There are no other differences between the proposed and predicate rods.
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Medyssey has determined that the minor differences between proposed screws to the predicate devices will not impact the safety or effectiveness of the pedicle screw systems for their intended use. Analysis has shown that the proposed screws are equivalent to the predicate devices.
#### ldentification of Legally Marketed Predicate Device:
Documentation was provided, which demonstrates that the subject Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods are substantially equivalent to the predicate devices the Novel and Zenius Spinal System. The proposed Medyssey device has the same indications for use and is manufactured from the same material. The minor differences in the design were evaluated through testing and do not affect the safety and efficacy of the screws for their intended use.
## Brief Discussion of Non-Clinical Tests Submitted:
Numerous tests were performed on the Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods. The tests performed are recommended by the FDA guidance document on spinal system 510(k) submissions and include ASTM F1717-04. List of Tests is below:
- Static Compression .
- Static Torsion .
- Static Tension .
- Dynamic Compression .
## Conclusions from Non-Clinical Tests:
Based on the testing and comparison analysis to the predicate devices provided in this premarket notification submission, Medyssey believes that the subject Cannulated Pedicle Screws and Co-Cr-Mo rods are substantially equivalent to the Novel and Zenius Screws.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 a stylized image of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 25, 2013
Medyssey Company Limited % Mr. Michael Kvitnitsky Chief Operating Officer 8001 North Lincoln Avenue, Suite 401 Skokie, Illinois 60077
Re: K121670
Trade/Device Name: Zenius, Iliad and Kora Spinal Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: January 16, 2013 Received: January 22, 2013
# Dear Mr. Kvitnitsky:
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 may, therefore, market the device, subject to the general controls provisions of the Act. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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# Page 2 - Mr. Michael Kvitnitsky
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
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 Form
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Medyssey Zenius, Iliad and Kora Systems
Indications for Use:
,
The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
# RonaldiPhylean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121670
Page 1 of 1
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.
