K973015 · Bonutti Research · MBI · Oct 9, 1997 · Orthopedic
Device Facts
Record ID
K973015
Device Name
MULTITAK SS SUTURE SYSTEM
Applicant
Bonutti Research
Product Code
MBI · Orthopedic
Decision Date
Oct 9, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3040
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder Bankart lesion repairs S.L.A.P. lesion repairs Acromio-clavicular Repairs Capsular Shift/Capsulolabral Reconstruction Deltoid Repair Rotator cuff tear repairs Biceps tenodesis Foot and Ankle Medial/lateral repairs, reconstructions Achilles tendon repairs Midfoot and forefoot repairs Hallux Valgus reconstruction Elbow Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment Knee Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Iliotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure Hand/Wrist Collateral ligament repair (Gamekeeper's Thumb) Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
Device Story
Multitak Suture System is a soft tissue anchor for orthopedic fixation. Device consists of a cylindrical anchor preassembled with braided polyester suture. Used by surgeons in clinical settings to secure soft tissue to bone. Surgeon inserts anchor into bone; attached sutures are used to reattach or repair damaged ligaments or tendons. System facilitates fixation in various anatomical sites including shoulder, knee, elbow, foot, ankle, and hand/wrist. Provides mechanical stability to soft tissue during healing process.
Clinical Evidence
Bench testing only. Pullout testing was performed to compare the Multitak Suture System against predicate devices, demonstrating equivalent or superior performance.
Technological Characteristics
Cylindrical anchor; braided polyester suture; metallic bone fixation fastener. Designed for soft tissue to bone fixation.
Indications for Use
Indicated for soft tissue to bone suture fixation in patients requiring repair or reconstruction of ligaments and tendons in the shoulder, knee, elbow, foot, ankle, and hand/wrist.
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.
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## I RESEARCH, INC
OCT - 9 1997
## 1303 evergreen avenue, effingham, illinois 62401 tel. (217) 342-3412 fax (217) 342-6416
## Summary of Safety and Effectiveness Multitak Suture System™
## Submitted by
Bonutti Research, Inc. 1303 Evergreen Ave. Effingham, IL 62401
#### Prepared by .
Lynnette Whitaker Director Regulatory Affairs/Quality Assurance
#### Date .
August 8, 1997
#### Trade Name .
Multitak Suture System
#### Common Name .
Soft Tissue Anchor
#### Classification Name .
21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener
#### Predicate Devices .
- Multitak SS Suture System, manufactured by Bonutti Research, K934183. .
- Multitak SS Suture System, manufactured by Bonutti Research, K964532. ●
- Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., . Statur 84, cleared November 16, 1993 and K962397, cleared August 27, 1996.
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## BONUTTI RESEARCH, INC
#### 1303 evergreen avenue, effingham, illinois 62401 tel. (217) 342-3412 fax (217) 342-5416
### Device Description
.
The anchor is cylindrical in shape and is preassembled threaded with USP size 2-0 I he anchor is cynnurear in shape and if production Device holds the anchor and through 2 braided poryester suture. The mass of the sutures can then be used to secure the soft tissue to the bone.
#### Intended Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
### Shoulder
- Bankart lesion repairs -
- S.L.A.P. lesion repairs -
- Acromio-clavicular Repairs -
- Capsular Shift/Capsulolabral Reconstruction -
- Deltoid Repair -
- Rotator cuff tear repairs -
- Biceps tenodesis -
#### Foot and Ankle
- Medial/lateral repairs, reconstructions 1
- Achilles tendon repairs -
- Midfoot and forefoot repairs -
- Hallux Valgus reconstruction -
#### Elbow
- Ulnar or radial collateral ligament reconstructions -
- Tennis elbow repair -
- Biceps tendon reattachment -
#### Knee
- Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament Posterior oblique ligament
- Iliotibial band tenodesis -
- Patellar tendon repair -
- -VMO advancement
- Joint capsule closure -
### Hand/Wrist
- Collateral ligament repair (Gamekeeper's Thumb) -
- -Scapholunate ligament reconstruction
- Tendon transfers in phalanx -
- Volar plate reconstruction -
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# NUTTI RESEARCH, INC
1303 evergreen avenue, effingham, illinois 62401 tel. (217) 342-3412 fax (217) 342-6416
## Performance Data
.
The Multitak Suture System was compared in pullout testing to the predicate I he Marinak Sutare System was vellipared sequal to or better than the predicate device(s).
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that form the body and wings, and the overall design is simple and clean.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1997
Lynnette Whitaker, RAC Director, Regulatory Affairs and Quality Assurance Bonutti Research 1303 Evergreen Avenue Effingham, Illinois 62401
Re: K973015 Multitak SS Suture System™ Trade Name: Requlatory Class: II Product Code: MBI Dated: August 8, 1997 Received: August 13, 1997
Dear Ms. Whitaker:
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 The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.
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Page 2 - Lynnette Whitaker, RAC
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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Page 1 of 1
510(k) Number (if known): K973015
Device Name: MULTITAK SUTURE SySTEM
Indications For Use:
The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications: Knee Shoulder Extra-capsular repairs: Bankart lesion repairs Medial collateral ligament S.L.A.P. lesion repairs Lateral collateral ligament Acromio-clavicular repairs Posterior oblique ligament Capsular shift/capsulolabral reconstruction Iliotibial band tenodesis Deltoid repair Patellar tendon repair Rotator cuff tear repairs VMO advancement Biceps tenodesis
Foot and Ankle Medial/lateral repairs, reconstructions Achilles tendon repairs (Gamekeeper's Thumb) Midfoot and forefoot repairs Hallux valgus reconstruction
Elbow
Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment
Joint capsule closure
Hand/Wrist Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) t ﺔ، ﻓ Division of General Restorative Devices 73015 510(k) Number Prescription Use OR Over-The-Counter Use_ (Per 21 CFR 801.109)
(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.
