The Arthrex Tenodesis Family of screws, made of various metals and polymers which are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
Device Story
Arthrex Tenodesis Screw Family consists of threaded, fully cannulated anchors with rounded heads; manufactured from various polymers or titanium metal. Used for soft tissue reattachment; fixation of ligament and tendon graft tissue. Surgical application in shoulder, elbow, foot/ankle, knee, and hand/wrist. Implantation performed by surgeons using specific instrumentation provided with the device. Device functions as a mechanical fastener to secure soft tissue to bone. Benefits include stable fixation of grafts and tissues during healing process. No electronic, software, or algorithmic components.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on design, material characterization, and comparison to predicate devices.
Technological Characteristics
Threaded, fully cannulated anchors with rounded heads. Materials: various polymers and titanium metal. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. Software: None.
Indications for Use
Indicated for soft tissue reattachment and fixation of ligament and tendon graft tissue in shoulder, elbow, foot/ankle, knee, and hand/wrist surgeries. Applicable to patients requiring reconstruction or repair of ligaments and tendons in these anatomical regions.
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.
Submission Summary (Full Text)
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K05-1726 pg192
SEP 2 7 2005
## 510(k) Summary
| 510(k) Number: | | Arthrex, Inc. |
|-----------------|--|---------------------------------------------|
| Company: | | |
| Address: | | 1370 Creekside Blvd., Naples, FL 34108-1945 |
| Telephone: | | (239) 643-5553 |
| Facsimile: | | (239) 598-5508 |
| Contact: | | Ann Waterhouse |
| Trade Name: | | Arthrex Tenodesis Screw Family |
| Common Name: | | Suture Anchor |
| Classification: | | Fastener, Fixation |
| Product Code: | | HWC, MAI, MBI |
## Description:
The Arthrex Tenodesis Family of screws are manufactured using a variety of polymers or titanium metal. They are threaded, fully cannulated anchors with a rounded head. The Tenodesis Screws are available with specific instrumentation to aide implantation.
## Indications for Use:
The Arthrex Tenodesis Family of screws, made of various metals and polymers which are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
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page 242
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The difference between the Arthrex Bio-Tenodesis Screw, Arthrex Titanium Tenodesis Screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a sans-serif font. The text is arranged around the circle, with "DEPARTMENT OF HEALTH AND HUMAN SERVICES" at the bottom and "USA" at the top.
SEP 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager Arthrex, Incorporated 1370 Creekside Boulevard Naples, Florida 34108
Re: K051726
Trade/Device Name: Arthrex Tenodesis Family Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI, MBI Dated: September 15, 2005 Received: September 19, 2005
Dear Ms. Waterhouse:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premated is substantially equivalent (for the indications
referenced above and have determined the device is subsets marketed in intersta referenced above and have decemblicate devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manated provice Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1970, the chactinent and other of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval provinces of the Act . The and Cosmetic Act (Act) that do not require upproval controls provisions of the Act. The Act. The Act. The You may, merelore, market the device, sayed to use include registration, listing of
general controls provisions of the Act include requirements michscanding and general controls provisions of the Frec merator required in the manage inst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo existing major regulations affecting your device can
may be subject to such additional controls. Tixis A. R. A. A. addition FDA may be subject to such additional controlis: Extrems, be found in the Code of Peacharts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substance or substition of the Act
that FDA has made a determination that your device complies with onemaiss. You must that FDA has made a delemination that your ac-ries by other Federal agencies. You must or any Federal statutes and regulations administers or registration and listing (21 l
comply with all the Act's requirements, including, but not his requirements as set comply with an the Act s requirements, more and manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing and if caplicable, th CFR Part 807); labeling (21 CFR 1 at 601); good market 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 form in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1
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Page 2- Ms. Ann Waterhouse, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manet.ing of substantial equivalence of your device to a legally prematicate 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 spochie advision at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Compination" (21CFR Part 807.97). You may obtain. Nusofanding of Terefores to presessibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html
Sincerely yours,
Mark A. Milikan
Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Arthrex Tenodesis Family
## Indications for Use:
Indications Tor USC.
The Arthrex Tenodesis Screws are constructed of various polymers and metals The Antirex Tenodols Ooft tissue reatachment, i.e. fixation of lighthis and and intended to provide ook toous foomlooder, elbow, knee, footlankle, and hand/wrist. Specifically;
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Kotator Out Ropaire, Bavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Eatchar Otablization, Midfoot Reconstruction, Metatarsal Hallax Valgair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Antonol - Graciato - Graciato - Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Radial Collateral Ligament Reconstruction, Reconstruction, (coonstracarpal joint arthroplasty (basal thumb joint arthroplasty), Carpornotations Reconstructions and repairs, tendon transfer in the hand/ wrist
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
Subpart C)
Concurrence of CDRH, Office of Device Evalyation (ODE)
Mark Millican
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
**510(k) Number** K051726
page 1 of
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.
