The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures.
Device Story
Intramedullary fixation system for proximal femoral fractures; components include intramedullary nail, lag screw, end cap, and optional anti-rotation screw. Lag screw provides dynamic fracture compression; anti-rotation screw provides rotational stability; end cap prevents bone ingrowth. Used by orthopedic surgeons in clinical/surgical settings. Device stabilizes bone segments to facilitate healing in stable/unstable fractures, including osteoporotic and complex diaphyseal cases.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.
Technological Characteristics
Material: Titanium alloy (Ti-6Al-4V ELI). Components: Intramedullary nail, lag screw, end cap, anti-rotation screw. Function: Intramedullary fixation rod for bone fracture stabilization. Design: Dynamic compression via lag screw; rotational stability via optional anti-rotation screw.
Indications for Use
Indicated for patients with stable/unstable proximal femoral fractures, including pertrochanteric, intertrochanteric, high subtrochanteric, and combinations thereof. Long nail version indicated for pertrochanteric fractures with shaft fractures, pathologic fractures in osteoporotic bone, long subtrochanteric fractures, ipsilateral femoral fractures, non-unions, malunions, and revision procedures.
Regulatory Classification
Identification
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
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| 510(k) Summary | | K042325<br>page 1 of 2 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No. 1818910 | |
| 510(K) CONTACT: | Steve Kahn<br>RA Director, Trauma and Extremities<br>Telephone: (574) 372-7180<br>Fax: (574) 371-4987 | |
| DATE PREPARED: | July 30, 2004 | |
| TRADE NAME: | Trochanteric Nail System | |
| COMMON NAME: | Bone fixation device | |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3020:<br>Intramedullary fixation rod<br>Description: Rod, Fixation, Intramedullary and<br>Accessories, Metallic and Non-collapsible | |
| DEVICE PRODUCT CODE: | HSB<br>No performance standards have been established<br>under section 514 of the Federal Food, Drug, and<br>Cosmetic Act for intramedullary nails | |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | DePuy Trochanteric Nail (K010780)<br>DePuy Trochanteric Nail (K013563) | |
## DEVICE DESCRIPTION:
The Trochanteric Nail System consists of an intramedullary nail, lag screw, end cap, and optional anti-rotation screw, all manufactured from titanium alloy (Ti-6Al-4V ELI), which are used to treat fractures in the proximal portion of the femur.
## INTENDED USE AND INDICATIONS:
The lag screw provides dynamic compression of the fracture; the anti-rotation screw can be used to prevent the rotation of the bone fracture segments, and the end cap prevents bone ingrowth. It is estimated that the AR screw is required in only five to ten percent of the cases where additional rotational stability of the fracture is required.
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures,
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K042325
page 2 of 2
ipsilateral femoral fractures, proximal or distal non-unions and malunic procedures.
# BASIS OF SUBSTANTIAL EQUIVALENCE:
Based on the same Intended Use, Indications for Use, materials, sterilization processes and Dascu on the same intended 050, mercanone for of the rest that the subject Trochanteric Sillifiantes of technological and goother. In the previously cleared DePuy predicate devices.
00000006
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design resembling an abstract human figure or a symbol representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP = 8 2004
Mr. Steve A. Kahn Regulatory Affairs Director, Trauma and Extremities DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K042325
Trade/Device Name: Trochanteric Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 12, 2004 Received: August 27, 2004
Dear Mr. Kahn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated) is the enactment date of the Medical Device Amendments, or to conimered prior to that 20, 2017 , 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 I ou may, thereforminens of the Act include requirements for annual registration, listing of general octurely profisevring 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 rr your device is elasellion (tional controls. Existing major regulations affecting your device can may be subject to back as a sublema, 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 i lease of actived that I Drivination that your device complies with other requirements of the Act that I Dri has Intact a statutes and regulations administered by other Federal agencies. You must or any I 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 forth in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Steve A. Kahn
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wifi anon. The FDA finding of substantial equivalence of your device to a legally prematicated predicated on "The 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 in you desire specific as noliance at (301) 594-4659. Also, please note the regulation entitled, Connact the Office of Coach to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international 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 vours,
Mark A. Milkersen
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 Ko4d3d5 510(k) Number (if known) Device Name: Trochanteric Nail System
## Indications for Use
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femures and I he Trochanteric Nan System is intention to tractures, high subtrochanteric fractures and including perfrochlanteric nactures, interactions is additionally indicated to treat combinations of these fractures. The Trochanterio Bong Fractures in osteoporotic bone of
pertrochanteric fractures associated with shaft fractures, pathologic fractures in os pertrochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, the dochanterio and chaptif son and malunions and revision procedures.
Prescription Use X (Part 21 CFR 801, Subpart D)
and/or
Over-the-Counter Use (21 CFR 807, Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED. Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millican
Division Sign-G Division of General, Restorative, and Neurological Devices
510(19 Number K092325
0000004
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.
