ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
K122059 · Smith & Nephew, Inc. · MBI · Mar 18, 2013 · Orthopedic
Device Facts
Record ID
K122059
Device Name
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
Applicant
Smith & Nephew, Inc.
Product Code
MBI · Orthopedic
Decision Date
Mar 18, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3040
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications: Hip Hip capsule repair (Acetabular labrum repair/reconstruction) Shoulder Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis Foot and Ankle Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy Elbow, Wrist, and Hand Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair Knee Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis
Device Story
SUTUREFIX Ultra Suture Anchor; soft tissue-to-bone fixation device. Consists of soft suture anchor with pre-attached non-absorbable suture(s) pre-loaded on insertion device. Used by orthopedic surgeons in clinical/OR settings. Device provides mechanical securement of soft tissue to bone during reconstructive or repair surgeries. Surgeon uses insertion device to place anchor; provides immediate fixation strength. Benefits patient by enabling stable tissue reattachment, facilitating healing in orthopedic repairs.
Clinical Evidence
Bench testing only. Performance data confirms device meets specifications for insertion strength and pull-out strength.
Technological Characteristics
Soft suture anchor with non-absorbable suture(s). Pre-loaded on insertion device. Single-use, sterile. Mechanical fixation principle.
Indications for Use
Indicated for patients requiring soft tissue-to-bone fixation in orthopedic procedures including hip capsule repair, shoulder capsular stabilization, rotator cuff repair, biceps tenodesis, foot/ankle ligament/tendon reconstruction, bunionectomy, elbow/wrist/hand ligament/tendon repair, and knee extra-capsular/patellar repairs.
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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Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA T 978-749-1000 F 978-749-1443 www.smith-nephew.com
- We are **smith&nephew**
# K122059
# page 1 of 2
MAR 1 8 2013
| Submitter Information | Contact Information |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Smith & Nephew, Inc.<br>150 Minuteman Road<br>Andover, MA 01810 | Anne-Marie Keefe<br>Senior Regulatory Affairs Specialist<br>Phone: (508) 261-3713<br>Fax: (978) 749-1443 |
| Device Name & Classification | |
|------------------------------|------------------------------------------------|
| Proprietary Name | SUTUREFIX Ultra Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | Fastener, fixation, nondegradable, soft tissue |
| Classification Regulation | 21 CFR 888.3040 |
| Class | II |
| Product Code(s) | MBI |
| Panel | Orthopedic |
#### Device Description
The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended to provide secure . fixation of soft tissue to bone. The device consists of a soft suture anchor with an attached non-absorbable suture(s) preassembled onto an insertion device. The SUTUREFIX Ultra Suture Anchors are available pre-loaded with either one #2 suture or with two #1 sutures. This device is provided sterile, for single use only.
## Predicate Devices ·
| Manufacturer | Description | Submission Number | Clearance Date |
|----------------------|--------------------------------|-------------------|----------------|
| Smith & Nephew, Inc. | BIORAPTOR 2.3 PK Suture Anchor | K121018 | June 22, 2012 |
| Biomet, Inc. | JuggerKnot® Soft Anchors | K110145 | March 4, 2011 |
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T 978-749-1000 F 978-749-1443 www.smith-nephew.com
#### K122059 page 2 of 2
#### Intended Use
The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:
#### Hip
Hip capsule repair (Acetabular labrum repair/reconstruction)
#### Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
#### Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy
#### Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
#### Knee
Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis
#### Technological Characteristics
The Smith & Nephew SUTUREFIX Ultra Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the legally marked predicate devices in commercial distribution and raises no new issues of safety and efficacy.
#### Summary Performance Data
Performance data demonstrates that the SUTUREFIX Ultra Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2013
Smith & Nephew, Incorporated % Ms. Anne-Marie Keefe Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K122059
Trade/Device Name: SUTUREFIX Ultra Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 7, 2013 Received: February 12, 2013
Dear Ms. Keefe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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#### Page 2 - Ms. Anne-Marie Keefe
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Premarket Notification Indications for Use Statement
510(k) Number (if known):K122059
SUTUREFIX Ultra Suture Anchor Device Name:
Indications for Use:
The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:
#### Hip
Hip capsule repair (Acetabular labrum repair/reconstruction)
#### Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
#### Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy
#### Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
#### Knee
Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis
Prescription Use X __ (Part 21 CFR 801.109)
AND/OR
Over-the-Counter Use (Optional Format 1-2-96)
#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
# Elizabet际圈Ærank -S
Division of Orthopedic Devices
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.
