K033717 · Bonutti Research, Inc. · HTY · Feb 25, 2004 · Orthopedic
Device Facts
Record ID
K033717
Device Name
TRANSET FRACTURE FIXATION SYSTEM
Applicant
Bonutti Research, Inc.
Product Code
HTY · Orthopedic
Decision Date
Feb 25, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3040
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The TranSet™ Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. The system consists of both absorbable and titanium fixation buttons used with up to USP Size No. 5-braided suture and are not intended for reuse. The system may also be used with the Unity Ultrasonic Fixation seat for tissue approximation and ligation when using USP Size No. 2-0 through 2-braided suture. Custom manual surgical instrumentation for button insertion and a sterilization tray complete the TranSet™ Fracture Fixation System. The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.
Device Story
TranSet™ Fracture Fixation System consists of cylindrical buttons (poly-L-lactic acid or titanium alloy) and manual surgical instrumentation. Buttons are applied to outer bone cortex or soft tissue repair sites; suture runs across fracture site to provide stabilization, linear fixation, and compression to promote healing. Buttons act as fixation posts, distributing suture tension to prevent tearing. Absorbable buttons degrade over time; titanium buttons may be removed per surgeon preference. Used in orthopedic procedures by surgeons. System includes sterilization tray for autoclaving. Benefits include stabilization of bone/tissue fragments and elimination of suture tearing.
Clinical Evidence
Bench testing only. Performance testing compared mechanical strengths and failure modes of absorbable and titanium buttons against stainless steel Steinmann Pins, demonstrating statistical equivalence.
Technological Characteristics
Materials: Poly-L-lactic acid (absorbable) and titanium alloy. Form factor: Cylindrical buttons. Energy source: None (manual instrumentation). Connectivity: None. Sterilization: Provided sterile (buttons); manual instrumentation requires autoclaving.
Indications for Use
Indicated for fracture repair of metaphyseal and periarticular small bone fragments where screws are not indicated; adjunct to external/intramedullary fixation, fracture braces, casting, and bone graft substitutes; ligament/tendon repair and reconstruction associated with fractures; soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. Contraindicated for intra-articular sites.
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.
Multitak Splinter 3.0 mm Resorbable Anchors (K012456)
Submission Summary (Full Text)
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Ko 337/7 pge 142
### FEB 2 5 2004
#### Bonutti Research, Inc., - TranSet™ Fracture Fixation System 510(k) Premarket Notification February 24, 2004
#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Patrick G. Balsmann, MS, RAC Director RA/QA & Clinical Bonutti Research, Inc. P.O. Box 1367, Effingham, Illinois 62401 Phone: (217) 342-3412, ext. 321
Date Prepared: November 25, 2003
Proprietary Name: TranSet™ Fracture Fixation System.
Common Name: Trauma Fracture Fixation System.
· Classification Name: 21 CFR 888.3040 Smooth or threaded mctallic bone fixation fastener and 21 CFR 878.4930 Suture retention device.
Device Deseription :- The TranSet ... Frantyre Fixation System intended use is in the stabilization and linear fixation of bone or tissue fragments in orthopedic fractures and in ligament and tendon repair and reconstruction. The system consists of both absorbable and titanium cylindrical huttons manufactured from poly-L-lactic acid or titanium alloy. The buttons are provided sterile packaged with or without braided suture and are intended for single-patient use. Buttons are applied to the outer bone cortex and with suture ruming across the fracture site allows for stabilization and linear fixation of the bone or tissue fragments. This allows the bone or tissue fragments to be compressed and held together to promote healing. The cylindrical design of the buttons also allows them to be used as fixation devices in orthopedic ligament and tendon repair and reconstruction. The buttons are placed outside the cortical bone or though a soft tissue repair site and act as fixation posts by distributing suture tension over larger areas to promote healing and eliminate any suture tearing or pulling through the tissue. The absorbable buttons degrade over time and eliminate the need for any surgical removal. Removal of the titanium buttons is based upon surgeon preference. Reusable manual surgical instrumentation for insertion of the buttons and a sterilization tray for autoclaving complete the system.
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K033717 page 1 of 1
Indications for Use: The TranSct"™ Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. The system consists of both absorbable and titanium fixation buttons used with up to USP Size No. 5-braided suture and are not intended for reuse. The system may also be used with the Unity Ultrasonic Fixation seat for tissue approximation and ligation when using USP Size No. 2-0 through 2-braided suture. Custom manual surgical instrumentation for button insertion and a sterilization tray complete the TranSctTM Fracture Fixation System.
The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.
Predicate Device (s): The TranSet " Fracture Fixation System is similar in intended use and materials to the Multitak SS Buttons (K990156), Linvatec, Corp., BioButton™ (K990194) and Inion, Ltd., OTPS 10 Biodegradable pins (K031712). The TranSet 1 Fracture Fixation System buttons are also similar in design and materials to the Multitak SS Buttons and the Multitak Splinter 3.0 mm Resorbable Anchors (K012456).
Predicate Comparison: Performance testing comparing the mechanical strengths and failure modes of the TranSet™ Fracture Fixation System absorbable and titanium buttons to stainless steel Steinmann Pins commonly used in fracture fixation procedures demonstrated the buttons are statistically equivalent.
**Submitted by:**
[signature]
Patrick G. Balsmann, MS, RAC Director, Regulatory/Clinical Affairs & OA
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# FEB 2 5 2004
Mr. Patrick G. Balsmann, MS, RAC Director, Regulatory/Clinical Affairs and Quality Assurance Bonutti Research, Inc. P.O. Box 1367 Effingham, Illinois 62401
Re: K033717
Trade/Device Name: TranSet™ Fracture Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: November 25, 2003 Received: November 28, 2003
Dear Mr. Balsmann:
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.
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 I·DA'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 - Mr. Patrick G. Balsmann, MS, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maing of substantial equivalence of your device to a legally prematicated predicate device results 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 If you desire specific advice for your ac (301) 594-4639. Also, please note the regulation entitled, contact the Ories of Come to premarket notification" (21CFR Part 807.97) you may obtain. . Misorunation on your responsibilities under the Act may be obtained from the Other general information on your respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millikum
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
Koss 717 510(k) Number (if known):
TranSet™ Fracture Fixation System. Device Name:
Indications For Use:
Indications for Use: The TranSet™ Franction System is indicated as an adjunct in
there serest Indications for Use: The Transcl fracture repair involving melapliysed as an adjunct to external and intramedullary fixation are not indicated. It may also be last as an allunces and casting, and with bone
systems involving fixation plates and roline to ligners and rendon repair and systems involving fixation plates and rous, with ligament and tendon repair and graft substitutes. The system is also manages and soft tissue realtachment including reconstruction avulsions and meniscal repairs. The system consists of both absorbable and ligament/tendon avulsions and member 10 USP Size No. 5-braided sutture and are not intended
titanium fixation buttons used with up to USP Size No. 5-bration seat for tissue titanium fixation buttons used with the Unity Uitrasonic Fixation seat for tissue
for reuse. The system may also be used with the Unity 2-D through 3-baided sulure. Clust for reuse. The system may also be used with the Unity Onlines of Straided sulure. Custom
approximation and ligation when issues and as sterligation trav complete the approximation and ligation when using UST 3120 No. I 6 all 05
manual surgical instrumentation for button insertion and a sterilization tray complete the TranSet IM Fracture Fixation System.
The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.
Prescription Use _ A (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ No (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
> Braluation (ODE) H. Office of Device Concurrence of CDF
Mark N. Milliken
Division of General, Restorative, and Neurological Devices
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
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.
