These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
Device Story
Inion OTPS™ Biodegradable Mini Plating System consists of resorbable screws used for bone fixation. Screws are manufactured from polylactic acid/trimethylenecarbonate and poly(L-lactide-co-trimethylenecarbonate). Device provides temporary mechanical support for bone healing; strength is maintained for 18-36 weeks in vivo, with complete resorption occurring within two to four years. Intended for use by surgeons in clinical settings to stabilize fractures, osteotomies, or grafts. Requires supplemental immobilization via rigid fixation, casts, or braces. Benefits include biocompatible material degradation, eliminating need for secondary removal surgery.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing demonstrating mechanical performance and biocompatibility of the resorbable material.
Technological Characteristics
Resorbable screws composed of polylactic acid/trimethylenecarbonate and poly(L-lactide-co-trimethylenecarbonate). Mechanical strength profile: 18-36 weeks in vivo; complete resorption: 2-4 years. Dimensions vary by application. Mechanical fixation principle.
Indications for Use
Indicated for alignment and fixation of bone fractures, osteotomies, arthrodeses, or bone grafts in patients requiring additional immobilization. Contraindicated for high-load bearing applications (e.g., long bone diaphyseal fractures) without rigid fixation, spine indications, active/potential infection, limited blood supply, insufficient bone quantity, or patients unable to cooperate (e.g., alcoholism, drug abuse).
Regulatory Classification
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
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K043142 pg. 172
FEB 1 8 2005
Image /page/0/Picture/2 description: The image shows the word "INION" in large, bold, white letters against a black background. Below the word "INION" is the phrase "Intelligent Solution" in a smaller, italicized font, also in white. The overall design is simple and clean, with a focus on the company name and its tagline.
### 510(k) SUMMARY
for the Inion OTPS™ 2.5/2.8/3.1 Biodegradable Screws
# MANUFACTURER
Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere
Contact Person: Hanna Marttila Regulatory Affairs Director Lääkärinkatu 2 FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 601 Hanna. Marttila@Inion.fi
### DEVICE NAME
Trade name: Inion OTPS™ Biodegradable Mini Plating System Common/Usual Name: Screw Classification Name: Fixation Fastener
## ESTABLISHMENT REGISTRATION NUMBER 9710629
# DEVICE CLASSIFICATION AND PRODUCT CODE Classification panel: Orthopedic
Regulatory Class: Class II 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87-HWC (Screw)
### PREDICATE DEVICES
Biomet Inc.; ReUnite Bone Screw (K992301) Linvatec Smart Screw (K003077)
Inion OTPS Screws extension
Date: Nov 12,2004 Status: Final
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Page of 2
# DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
Screws are generally intended for alignment and fixation of bone The Inion OTPS™ fractures, osteotomies, arthrodeses and bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast or prosence or appropriate fered in several dimensions and lengths typical for this application.
The Inion OTPS™ Screws are made of resorbable polylactic acid / trimethylenecarbonate The Imon OTI & - Leactide-co-D,L-lactide) and poly (L-lactide-co-trimethylenecarbonate)]. The Inion OTPS™ Screw gradually loses its strength during 18-36 weeks in vivo with complete strength loss and resorption within two to four years.
# EQUIVALENCE TO MARKETED PRODUCTS
Based on the performance data presented in section I of this premarket notification it is stated Dasod on the perfectionery are substantially equivalent to similar marketed devices, such as that the ReUnite Screw 2.0/2.5 (K992301) and Linvatec SmartScrew (K003077).
The data demonstrates, that
1) Inion OTPS™ Screws retain sufficient mechanical characteristics to fulfil their intended function during bone healing according to their indications, and
2) the material and degradation by-products of the Inion OTPS™ Screws are biocompatible, with no short- or long-term safety concerns. Furthermore, there are no new risks associated with use of the Inion OTPS™ Screws as compared to the predicate biodegradable implants listed above.
Inion OTPS™ Screws are substantially equivalent to predicate Class II devices used for alignment and fixation of fractures, osteotomies, arthrodeses and bone grafts (i.e., autografts anginnents) in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast or brace), because the differences between the Inion OTPS™ Screws and these predicate devices do not raise new questions of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 symbol featuring three curved lines that resemble a human figure.
Public Health Service
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Hanna Marttila Director, Regulatory Affairs Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere, Finland
Re: K043142
:
Trade/Device Name: Inion OTPSTM 2.5/2.8/3.1 Screws Inion OTPS™ Biodegradable Mini Plating System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 1, 2005 Received: February 3, 2005
Dear Ms. Marttila:
We have reviewed your Section 510(k) premarket notification of intent to market the device w for hove and have 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 arior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that provision in the provision 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 - Ms. Marttila
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and in yourse organizatial equivalence of your device to a legally premaince notification: "Thesalts in a classification 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), please ir you at the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of general miormation on Journational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html
Sincerely yours,
Mark A. Milken
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
510(k) Number (if known): K043142
Inion OTPS™ 2.5/2.8/3.1 Screws Device Name:
Inion OTPS™ Biodegradable Mini Plating System
#### INDICATIONS:
These INION OTPSTM BIODEGRADABLE FIXATION SYSTEM implants are intended for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
#### CONTRAINDICATIONS:
These INION OTPS™ BIODEGRADABLE FIXATION SYSTEM implants are not intended for use in and are contraindicated for:
- High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in . conjunction with traditional rigid fixation.
- . Spine indications.
- I Active or potential infection.
- Patient conditions including limited blood supply, insufficient quantity of bone; . and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse).
Prescription Use 2 4 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use No
(21 CFR 801 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marti A. Melleen
(Division Sign-OLL)
Division of General, Restorative,
and Neurological Devices
Page 1 of /
*510(k) Number* K043142
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.
