The Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and ostetotomies. Examples include, but are not limited to scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Device Story
Synthes 3.0 mm Headless Compression Screws are metallic bone fixation fasteners used by surgeons for small bone fracture fixation and arthrodesis. The device is a cannulated, self-drilling, self-tapping screw featuring a stardrive mechanism and a threaded head designed to be countersunk into bone. Available in stainless steel or titanium alloy, with thread lengths from 10 mm to 40 mm. The device provides mechanical compression across fracture sites or joints to facilitate healing. It is intended for clinical use by orthopedic or hand surgeons in an operating room setting.
Clinical Evidence
No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to the predicate device.
Technological Characteristics
Materials: Stainless Steel and Titanium Alloy. Design: Cannulated, self-drilling, self-tapping, headless screw with stardrive mechanism. Dimensions: 3.0 mm diameter, 10-40 mm thread lengths. Energy source: None (manual surgical instrument). Sterilization: Not specified.
Indications for Use
Indicated for fixation of intra-articular and extra-articular fractures, non-unions, arthrodeses, bunionectomies, and osteotomies of small bones and fragments (e.g., scaphoid, carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head, radial styloid).
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.
Predicate Devices
Synthes 3.0 mm Sterile 3.0 mm Cannulated Screw and Threaded Washer
Submission Summary (Full Text)
{0}------------------------------------------------
KOSD636
Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line runs underneath the word and logo. There is a registered trademark symbol to the right of the word.
APR 2 1 2005
| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>(610) 719-5000 | |
| Device Name: | Synthes 3.0mm Headless Compression Screws | |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener. | |
| Predicate Devices: | Synthes 3.0 mm Sterile 3.0 mm Cannulated Screw and Threaded<br>Washer | |
| Device Description: | The Synthes 3.0 mm Headless Compression Screws are cannulated<br>and are self-drilling / self-tapping with a stardrive mechanism, and<br>have a threaded head which can be countersunk into the bone. The<br>screws are available in short and long thread lengths ranging from<br>10 mm to 40 mm. The screws are available in Stainless Steel and a<br>Titanium Alloy. | |
| Intended Use: | The Synthes 3.0 mm Headless Compression Screws are intended<br>for fixation of intra-articular and extra-articular fractures and non-<br>unions of small bones and small bone fragments; arthrodeses of<br>small joints; bunionectomies and ostetotomies. Examples include,<br>but are not limited to scaphoid and other carpal bones, metacarpals,<br>tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head<br>and radial styloid. | |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. | |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2005
Ms. Sheri L. Musgnung Senior Regulatory Specialist Synthes (USA) 1302 Wrights Lane West Chester, Pennsylvania 19380
Re: K050636
Trade/Device Name: Synthes (USA) 3.0 mm Headless Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 10, 2005 Received: March 11, 2005
Dear Ms. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocures in 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 encrosule) to regally manation in the Medical Device Amendments, or to Conniered price to May 20, 1978, in eccordance with the provisions of the Federal Food, Drug, devices that have been rochasined in avere approval of a premarket approval application (PMA). and Cosmetic 71ct (11ct) that do not request in the general controls provisions of the Act. The Tou may, uteretore, market are as act include requirements for annual registration, listing of gencial controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is eassified (dee ass ( ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Peachards concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I DA 3 issuates or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally it cochal statutes and regarations ancluding, but not limited to: registration and listing (21 comply with an the Act 31equirements, nieteams, and manufacturing practice requirements as set CTN in the quality systems (QS) certer an 800); and If applicable, the electronic a form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
Page 2- Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Section 5 0(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the s premarket notification: "The PDF Imaning sification 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 do not to read to car and the regulation entitled, the regulation Contact the Office of Comphalled at (210) = 16 = 16 = 1 = 1 807.97). You may obtain "Misbranding by reletence to premarket noultied.com the Act from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or and findex bird Manufacturers, Internet and Consailer risolors of the cov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present below the word, adding a sense of completion to the design. The registered trademark symbol is located to the right of the word.
of Page 1
Indications for Use
510(k) Number (if known):
Synthes (USA) 3.0 mm Headless Compression Screws
Indications for Use:
Device Name:
2.0
The Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular
1.0 mm Headless Compression of world hones and small bones fragments: The Synthes 3.0 mm Headless Compression of small bones and small bones fragments;
and extra-articular fractures and non-unions of small bones include, hul a and extra-articular fractures and noll-miss and osteologies. Examples include, but are not
arthrodeses of small joints; bunionectomies and osterolo materas; patella, ulpar arthrodeses of small joints; outlouccomes and corocolorized = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = minted to soapitellum, radial head and radial styloid.
Prescription Use _ X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Styd Clurlo
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-( Diff (Division Division of Seneral, Restorative and Nourological Devices
510(K) Number: K050636
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.
