(142 days)
Not Found
No
The 510(k) summary describes a mechanical soft tissue anchor and does not mention any AI or ML components or functionalities.
Yes.
The device is used for soft tissue to bone fixation, which treats a medical condition by restoring anatomical structure.
No
The device, JuggerKnot™ Mini Soft Anchors, is described as intended for soft tissue to bone fixation and is used in surgical procedures like Bankart repair or ligament reconstruction. It is a therapy device, not a diagnostic one.
No
The device description clearly states that the device consists of a "coreless sleeve structure and suture," which are physical components, not software. The performance studies also focus on mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- JuggerKnot™ Mini Soft Anchors Function: The description clearly states that the JuggerKnot™ Mini Soft Anchors are intended for soft tissue to bone fixation during surgical procedures. They are implanted into the body to hold tissues in place.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:
Shoulder Bankart repair
Foot and Ankle Midfoot Reconstruction, Hallux valgus reconstruction
Hand and Wrist Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal, DIP (distal interphalangeal), and MCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.
Product codes
MBI
Device Description
The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Hand and Wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Testing: Non-clinical laboratory testing was performed to verify the fixation strength of the JuggerKnot™ Mini Soft Anchors in mechanical pullout testing as compared to the predicate devices. The efficacy of the JuggerKnot™ Mini Soft Anchors was compared to that of the Mitek® Mini QUICKANCHOR® Plus and the Mitek® Microfix QUICKANCHOR® Plus. The test results indicate that the Biomet Sports Medicine JuggerKnot™ Mini Soft Anchors provide equivalent fixation strength to the predicate devices and would be functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
K110879(1/2)
Image /page/0/Picture/1 description: The image shows the logo for Biomet Sports Medicine. The word "BIOMET" is in a bold, sans-serif font with a unique design, and the words "SPORTS MEDICINE" are printed in a smaller, sans-serif font below the main logo. The logo is black and white.
AUG 1 9 2011
510(k) Summary
| Preparation Date: | June 6, 2011 |
|---|---|
| Applicant/Sponsor: | Biomet Sports Medicine |
| Contact Person: | Elizabeth Wray / Regulatory Project Manager |
| Victor Rodgers / Director of Quality, Clinical, & Regulatory Affairs | |
| 574-267-6639 | |
| Proprietary Name: | JuggerKnot™ Mini Soft Anchors |
| Common Name: | Soft Tissue Fixation Device |
| Classification Name: | Fastener, fixation, nondegradable, soft tissue |
| (21CFR §888.3040) MBI |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| K992487 | Mitek® Mini QA+ Anchor |
|---|---|
| K080352 | Mitek® Micro QA+ with #3-0, #4-0 Orthocord Anchor/ Mitek Microfix QA+ |
| with #3-0, #4-0 Orthocord Anchor |
Device Description:
The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
Intended Use / Indications for Use:
The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:
Shoulder
Bankart repair
Foot and Ankle
Midfoot Reconstruction, Hallux valgus reconstruction
Hand and Wrist
Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal, DIP (distal interphalangeal), and MCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: 574.267.8137
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
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Summary of Technologies:
The technological characteristics (materials, design, sizing and indications) of the JuggerKnot™ Mini Soft Anchors are similar or identical to the predicate devices and other soft tissue fixation devices.
Non-Clinical Testing:
Non-clinical laboratory testing was performed to verify the fixation strength of the JuggerKnot™ Mini Soft Anchors in mechanical pullout testing as compared to the predicate devices. The efficacy of the JuggerKnot™ Mini Soft Anchors was compared to that of the Mitek® Mini QUICKANCHOR® Plus and the Mitek® Microfix QUICKANCHOR® Plus. The test results indicate that the Biomet Sports Medicine JuggerKnot™ Mini Soft Anchors provide equivalent fixation strength to the predicate devices and would be functional within their intended use.
Clinical Testing:
None provided as a basis for substantial equivalence.
All trademarks are the property of Biomet, Inc., except for Mich are the property of DePuy Mich are the property of DePury Mick / Miek Products.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Sports Medicine % Ms. Elizabeth Wray Senior Regulatory Specialist 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581-0587
Aug 1 9 2011
Re: K110879
Trade/Device Name: JuggerKnot™ Mini Soft Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bond fixation fastener Regulatory Class: II Product Code: MBI Dated: July 22, 2011 Received: July 25, 2011
Dear Ms. Wray:
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.
ff 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
3
Page 2 - Ms. Elizabeth Wrav
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/ucm 1 1 5809.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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Eunice Keith
Ja-Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _
Device Name: JuggerKnot™ Mini Soft Anchors
Indications For Use:
The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:
Shoulder Bankart repair
Foot and Ankle Midfoot Reconstruction, Hallux valgus reconstruction
Hand and Wrist
Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal, DIP (distal interphalangeal), and MCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.
AND/OR
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
for M. Melkerm
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110879