The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications : Shoulder 1. Bankart lesion repairs 2. SLAP lesion repairs 3. Acromio-clavicular separation repairs 4. Rotator cuff tear repairs 5. Capsular shift or capsulolabral reconstructions 6. Biceps tenodesis 7. Altoid repairs Foot and Ankle 1. Hallux Valgus repairs 2. Medial or lateral instability repairs/reconstructions 3. Achilles tendon repairs/reconstructions 4. Midfoot reconstructions Elbow, Wrist and Hand 1. Scapholunate ligament reconstructions 2. Ulnar or radial collateral ligament reconstructions 3. Tennis elbow repair 4. Biceps tendon reattachment Knee 1. Extracapsular repairs and reattachments of: a. medial collateral ligament b. lateral collateral ligament c. posterior oblique ligament or joint capsule to tibia d. joint capsule closure to anterior proximal tibia 2. Extracapsular reconstruction, Iliotibial band tenodesis 3. Patellar realignment and tendon repairs Bladder Neck Suspension 1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.
Device Story
Pre-loaded Bio-Anchor is an injection-molded poly(L-lactic) acid suture anchor with attached nonabsorbable braided polyester suture (USP size #2). Device features circular ribs with three cylindrical holes perpendicular to long axis. Suture passes through anchor eyelet and attaches to wire via shrink tubing. Used in arthroscopic or open surgical procedures by surgeons to reattach soft tissue to bone. Device provides mechanical fixation for various orthopedic and urological repairs. Single-use, sterile, ETO-sterilized.
Clinical Evidence
No clinical data provided; substantial equivalence supported by bench testing.
Technological Characteristics
Anchor material: Poly(L-lactic) acid. Suture: Non-absorbable braided polyester (USP #2). Suture sleeve: FEP Teflon. Shrink tube: MIL-1023053/11B or polyester. Wire: 316 stainless steel. Dimensions: 3.5mm x 10.5mm. Single-use. ETO sterilization.
Indications for Use
Indicated for patients requiring soft tissue-to-bone fixation in shoulder, knee, foot, ankle, elbow, wrist, hand, and bladder neck suspension procedures (including female urinary incontinence due to urethral hypermobility).
Regulatory Classification
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
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# OCT 21 1998
October 15,1998
### SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is the 510(k) Summary of Safety and submitting hereby Effectiveness for the Pre-loaded Bio-Anchor Absorbable Suture Anchor, 510(k) Number K983186.
#### A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
K983186
#### Company Contact B.
Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs
:
#### c. Device Name
Trade Name:
| | | Bioabsorbable Suture Anchor |
|-----------------------|---|-----------------------------------------|
| Common Name | : | Suture Anchor |
| Classification Names | : | None Assigned |
| Proposed Class/Device | : | Class II, 87 MAI, Fastener |
| Product Code | : | Fixation, Biodegradable,<br>Soft Tissue |
Bio-Anchor, Pre-loaded
#### Predicate/Legally Marketed Devices D.
Bio-Anchor Linvatec Corporation
Pre-loaded Soft Tissue Anchors Revo/Mini Revo Linvatec Corporation
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Summary of Safety and Effectiveness Pre-loaded Bio-Anchor Absorbable Suture Anchor 510 (k) # K983186 October 15, 1998 Page 2 of 4
### E. Device Description
The Pre-loaded Bio-Anchor is an injection molded Poly (Llactic) acid suture anchoring device with an attached nonabsorbable braided polyester surure USP size #2. The device circular ribs in shape with three cylindrical i s perpendicular to the long axis. The suture is passed through the eyelet of the anchor and attached to a wire by shrink tubing.
#### F. Intended Use
The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications :
#### Shoulder
- 1. Bankart lesion repairs
- 2. SLAP lesion repairs
- 3. Acromio-clavicular separation repairs
- 4. Rotator cuff tear repairs
- 5. Capsular shift or capsulolabral reconstructions
- 6. Biceps tenodesis
- 7. Altoid repairs
#### Foot and Ankle
- 1. Hallux Valgus repairs
- 2. Medial or lateral instability repairs/reconstructions
- 3. Achilles tendon repairs/reconstructions
- 4. Midfoot reconstructions
#### Elbow, Wrist and Hand
- 1. Scapholunate ligament reconstructions
- 2. Ulnar or radial collateral ligament reconstructions
- 3. Tennis elbow repair
- 4. Biceps tendon reattachment
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Summary of Safety and Effectiveness Pre-loaded Bio-Anchor Absorbable Suture Anchor 510 (k) # K983186 October 15, 1998 Page 3 of 4
### F. Intended Use (con't)
#### Knee
- l. Extracapsular repairs and reattachments of:
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament or joint capsule to tibia
- d. joint capsule closure to anterior proximal tibia
- 2. Extracapsular reconstruction, Iliotibial band tenodesis
- 3. Patellar realignment and tendon repairs
#### Bladder Neck Suspension
- 1. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.
#### Substantial Equivalence ઉં.
The Pre-loaded Bio-Anchor is substantially equivalent in design, function and intended use to the Bio-Anchor (Linvatec Corporation), and the Revo/Mini Revo Preloaded Suture Anchors, (Linvatec Corporation) .
Testing has been done to prove safety and effectiveness of the devices.
The similarities/dissimilarities to the predicates are shown in the attached table.
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Summary of Safety and Effectiveness Pre-loaded Bio-Anchor Absorbable Suture Anchor 510(k) # K983186 October 15, 1998 Page 4of 4
## CHART OF SIMILARITIES AND DISSIMILARITIES
| CHART OF SIMILARITIES AND DISSIMILARITIES | | | | | |
|----------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------|
| Company | Device Name | Intended Use | Material | Single-Use<br>Reusable | Sizes |
| NEW PRODUCT<br>Linvatec | Pre-loaded Bio-<br>Anchor<br>Absorbable<br>Suture Anchor | Soft tissue to bone<br>fixation for shoulder,<br>knee, foot, ankle,<br>elbow, wrist, hand, and<br>bladder neck suspension<br>procedures. | Anchor: Poly (L-lactic)acid<br>Suture: Non-absorbable<br>braided polyester<br>Suture Sleeve: FEP Teflon<br>Shrink Tube, MIL-<br>1023053/11B or Polyester<br>Shrink Tube<br>Wire: 316 Stainless Steel | Single-Use<br>ETO Sterilization<br>Shipped Sterile | Anchor: 3.5mm x 10.5mm<br>Suture: USP Size #2 |
| PREDICATE<br>Linvatec<br>Bio-Anchor<br>510(k)<br>#K964805<br>#K963369 | Bio-Anchor | Soft tissue to bone<br>fixation for shoulder,<br>knee, foot, ankle,<br>elbow, wrist, hand, and<br>bladder neck suspension<br>procedures. | Poly (L-lactic)acid | Single-Use<br>ETO Sterilization<br>Shipped Sterile | 3.5mm x 10.5mm |
| PREDICATE<br>Linvatec<br>Pre-loaded Soft<br>Tissue Anchors<br>510(k)<br>#K953954 | Revo/Mini Revo | Soft tissue to bone<br>fixation. | Anchor: Titanium Alloy<br>Suture: Non-absorbable<br>braided polyester<br>Suture Sleeve: FEP Teflon<br>Shrink Tube, MIL-<br>1023053/11B or Polyester<br>Shrink Tube<br>Wire: 316 Stainless Steel | Single-Use<br>Gamma Sterilization<br>Shipped Sterile | Anchors: 2.5mm - 5.2mm<br>Suture: USP Sizes #0<br>to #2 |
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Image /page/4/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. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773
K983186 Re: Trade Name: Pre-loaded Bio-Anchor Absorbable Suture Anchor Requlatory Class: II Product Codes: MAI, HWC, and GAT September 10, 1998 Dated: Received: September 11, 1998
Dear Dr. Weideman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. તે substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Carol A. Weideman, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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September 10, 1998
510(k) Number (if known): K983186
Device Name: Pre-loaded Bio-Anchor Absorbable Suture Anchor
Indications for Use:
The Pre-loaded Bio-Anchor is a bioabsorbable device with attached suture used to attach soft tissue to bone in arthroscopic or open procedures for the following indications:
### Shoulder
- Bankart lesion repairs 1.
- 2. SLAP lesion repairs
- Acromio-clavicular separation repairs 3.
- Rotator cuff tear repairs বা বা বা বা বা করে আর করে আর করে আর করে আর করে আর করে আর করে আর করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার করে আমার
- Capsular shift or capsulolabral reconstructions 5.
- Biceps tenodesis 6.
- Altoid repairs 7.
### Foot and Ankle
- Hallux Valgus repairs 1.
- Medial or lateral instability repairs/reconstructions 2.
- Achilles tendon repairs/reconstructions 3.
- 4 . . Midfoot reconstructions
### Elbow, Wrist and Hand
- 1. Scapholunate ligament reconstructions
- Ulnar or radial collateral ligament reconstructions 2.
- ကိုးက Tennis elbow repair
- Biceps tendon reattachment 4 . .
#### Knee
- 1. Extracapsular repairs and reattachments of:
a. medial collateral ligament b. lateral collateral ligament c. posterior oblique ligament or joint capsule to tibia d. joint capsule closure to anterior proximal tibia
- Extracapsular reconstruction, Iliotibial band tenodesis 2.
- 3. Patellar realignment and tendon repairs
Pcodefe
**(Division Sign-Off)**
Division of General Restorative Devices
510(k) Number
Kg983182
**Prescription Use**
(Per 21 CFR 801.109)
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Indications for Use (con't):
### Bladder Neck Suspension
- l. Soft tissue fixation of the pubic bone for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) |
|-------------------------------------------------------|
|-------------------------------------------------------|
| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K983186 |
Prescription Use X OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
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(Optional Format 1-2-96)
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.
