The Kentrospine PSS Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with following indications: degenerative disc disease (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 stenoss; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
Device Story
Kentrospine PSS Pedicle Screw System is a top-loading, posterior spinal fixation system; components include monoaxial/polyaxial pedicle screws, rods, locking caps, and crosslink connectors. Used by surgeons in clinical settings to build spinal implant constructs to stabilize the spine and promote fusion. Implants are made of Ti6Al4V ELI titanium alloy; specialized instruments are made of 316L stainless steel. System provides rigid fixation and stability for various spinal pathologies. Surgeons select appropriate screw/rod sizes to construct the fixation assembly based on patient anatomy and clinical needs.
Clinical Evidence
No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including static compression bending, static torsional testing, static tension bending, and fatigue compression testing per ASTM F1717-21.
Technological Characteristics
Top-loading posterior spinal fixation system. Materials: Ti6Al4V ELI titanium alloy (ASTM F136-13(2021)) for implants; 316L stainless steel (ASTM F899-20) for instruments. Components: monoaxial/polyaxial screws, rods, locking caps, crosslink connectors. Supplied non-sterile, single-use. Mechanical testing performed per ASTM F1717-21.
Indications for Use
Indicated for skeletally mature patients requiring posterior, non-cervical spinal fixation as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or 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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July 22, 2022
Rivarp Medical Private Limited Sushma N.R Manager - RA No.34, Azeez Sait Industrial Town, 6th Mile, Mysore Road,Nayandahalli. Bangalore, Karnataka 560039 India
Re: K220486
Trade/Device Name: Kentrospine PSS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 29, 2022 Received: July 6, 2022
Dear Sushma N.R:
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. Although this letter refers to your product as a device, please be aware 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 807); labeling (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K220486
Device Name Kentrospine PSS Pedicle Screw System
### Indications for Use (Describe)
The Kentrospine PSS Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with following indications: degenerative disc disease (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 stenoss; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) SUMMARY
## Premarket Notification 510(k) Summary as required by Section 21 CFR 807.92
# General Company Information as required by 807.92 (a)
| Submitter's Name /<br>Contact details: | Rivarp Medical Pvt.Ltd.,<br># 34, Azeez Sait Industrial Town, 6th Mile<br>Mysore Road, Nayandahalli,<br>Bangalore -560039, INDIA<br>+91 80 2339 1136<br>info@rivarpmedical.com<br>www.rivarpmedical.com | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Details:<br>Sushma N.R<br>Manager- Regulatory affairs<br>+91 80 2339 1136 | |
| Summary preparation<br>date: | 20th July 2022 | |
| Device name and<br>classification: | Proprietary/ trade name:<br>Common or Usual Name:<br>Classification Name:<br>Product Code(s):<br>Device Class:<br>Regulation Number:<br>Review Panel: | Kentrospine PSS Pedicle Screw System<br>Pedicle Screw System<br>Thoracolumbosacral Pedicle Screw System<br>NKB<br>Class II<br>21 CFR Section 888.3070<br>Orthopedic |
| Variants/Types: | Kentrospine PSS Pedicle Screw System consists of following<br>components.<br>• PSS Monoaxial Pedicle Screw<br>• PSS Polyaxial Pedicle Screw<br>• PSS Locking Cap<br>• PSS Crosslink Connector<br>• PSS Rod | |
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#### The identified primary predicate device within this submission is as follows: Identification of the predicate device: CD HORIZON® Spinal System (K091442) manufactured by Medtronic Sofamor Danek USA, dated July 15 2009. The design features, material and indications for use of the Kentrospine PSS Pedicle Screw System are substantially equivalent to the predicate CD HORIZON® Spinal System.
The purpose of this Traditional 510(k) submission is to obtain market clearance Device Description: for the Kentrospine PSS Pedicle Screw System. The Kentrospine PSS Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of PSS Pedicle Screws (Monoaxial, polyaxial), PSS Rods, PSS Locking Cap, and a PSS Crosslink Connectors.
> The Kentrospine PSS Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Kentrospine PSS Pedicle Screw System components are supplied non-sterile, single use and are made from medical grade. biocompatible Titanium alloy (Ti6Al4V ELI) conforming to ASTM F136-13(2021)- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. Various sizes of these implants are available.
> The PSS Pedicle Screws are available in diameters from Ø4.50mm to Ø7.00mm and in lengths of 25mm to 55mm. PSS Rods are straight, made from titanium and available in 05.50mm diameter with length from 45mm, 55mm, 65mm, 75mm, 85mm, 100mm, 125mm, 200mm, 250mm, 300mm, 350mm, 450mm and 500mm.
> Specialized instruments are available for the application and removal of the Kentrospine PSS Pedicle Screw System. The instruments are made from SAE 316L stainless steel which is complied with ASTM F899 - 20 Standard Specification for Wrought Stainless Steels for Surgical Instruments.
## Indications for use:
The Kentrospine PSS Pedicle Screw System is intended for posterior, noncervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with following indications: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed studies): Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis and/or lordosis); Tumor; Pseudarthritis; and/or failed previous fusion.
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| Comparison to<br>Technological<br>Characteristics: | The Kentrospine PSS Pedicle Screw System is equivalent to the predicate<br>device with respect to intended use, device design and material. All the<br>necessary performance test to determine the mechanical characteristics have<br>been performed on the Kentrospine PSS Pedicle Screw System |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data:<br>1.Non-clinical<br>Performance: | The following tests have been conducted on the Kentrospine PSS Pedicle<br>Screw System and the device performance has been demonstrated against<br>following applicable standards, |
| | 1. Static compression bending testing (ASTM F 1717-21)<br>2. Static Torsional Testing (ASTM F 1717-21)<br>3. Static Tension bending Testing (ASTM F 1717-21)<br>4. Fatigue Compression testing (ASTM F 1717-21) |
| | The results of this non-clinical testing shows that the strength and performance<br>of the Kentrospine PSS Pedicle Screw System is sufficient for its intended use<br>and is substantially equivalent to legally marketed predicate devices. |
| | Following are the applicable material standards considered for Kentrospine<br>PSS Pedicle Screw System:<br>1. ASTM F136-13(2021)-Standard Specification for Wrought Titanium-<br>6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI) for<br>Surgical Implant Applications.<br>2. ASTM F899 – 20 Standard Specification for Wrought Stainless Steels for<br>Surgical Instruments. |
| 2. Clinical<br>Performance<br>Data/Information: | No clinical studies were performed. |
| Conclusion: | The Kentrospine PSS Pedicle Screw System is equivalent to the identified<br>primary predicate device. From the data available we can justify that the<br>Kentrospine PSS Pedicle Screw System has the same indications for use<br>and similar technological characteristics as the legally marketed predicate<br>device. Hence Kentrospine PSS Pedicle Screw System can be considered<br>substantially equivalent to the predicate. |
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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
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.
