(45 days)
Not Found
No
The summary describes a mechanical soft tissue anchor and does not mention any AI or ML components or functions.
Yes
The device is used for soft tissue to bone fixation, which is a therapeutic purpose.
No
Explanation: The device is intended for soft tissue to bone fixation, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it consists of a "coreless sleeve structure and suture," which are physical components, not software. The performance studies also focus on mechanical testing of fixation strength.
Based on the provided information, the JuggerKnot™ Soft Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The JuggerKnot™ Soft Anchor is a surgical implant intended for soft tissue to bone fixation within the body. It is a physical device used during surgery, not a tool for analyzing biological samples.
The description clearly states its purpose is for "soft tissue to bone fixation" in various anatomical locations. This is a therapeutic or reconstructive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The JuggerKnot™ Soft Anchor is intended to be used for soft tissue to bone fixation with indications for use in:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The JuggerKnot™ 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, Ankle, Elbow, Knee, Hand, Wrist, Hip
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory testing was performed to verify the fixation strength of the JuggerKnot™ Soft Anchors in mechanical pullout testing as compared to the predicate devices for specific indications for use. The efficacy of the JuggerKnot™ Soft Anchors was compared to that of the Biomet Sports Medicine Sleeve and Button Soft Tissue Fixation Devices. The test results indicate that the Biomet Sports Medicine JuggerKnot™ Soft Anchors provide equivalent fixation strength to the predicate devices and would be functional within their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text starts with "K110145" on the first line, followed by "p1/2" on the second line. The handwriting is somewhat uneven, and the characters are spaced irregularly.
Image /page/0/Picture/1 description: The image shows the logo for Biomet Sports Medicine. The logo is in black and white and features the word "BIOMET" in a stylized font. Below the word "BIOMET" is the phrase "SPORTS MEDICINE" in a smaller, sans-serif font. The logo is simple and professional, and it is likely used to represent the company's brand.
MAR - 4 2011
510(k) Summary
| Preparation Date: | January 17, 2011 |
|---|---|
| Applicant/Sponsor: | Biomet Sports Medicine |
| Contact Person: | Elizabeth Wray / Regulatory Project Manager |
| Victor Rodgers / Director of Quality, Clinical, & Regulatory Affairs | |
| Proprietary Name: | JuggerKnot™ 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:
K071704 Sleeve and Button Soft Tissue Fixation Devices / Biomet Sports Medicine
Device Description:
The JuggerKnot™ 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™ Soft Anchor is intended to be used for soft tissue to bone fixation with indications for use in:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: 574.267.8137
www.biomet.com
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
1
K110145
pH2
Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Summary of Technologies:
The technological characteristics (materials, design, sizing and indications) of the JuggerKnot™ Soft Anchors are similar or identical to the predicate devices or other previously cleared devices.
Non-Clinical Testing:
Non-clinical laboratory testing was performed to verify the fixation strength of the JuggerKnot™ Soft Anchors in mechanical pullout testing as compared to the predicate devices for specific indications for use. The efficacy of the JuggerKnot™ Soft Anchors was compared to that of the Biomet Sports Medicine Sleeve and Button Soft Tissue Fixation Devices. The test results indicate that the Biomet Sports Medicine JuggerKnot™ 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.
2
Image /page/2/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 perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet, Inc. % Ms. Elizabeth Wray Regulatory Project Manager 56 East Bell Drive - P.O. Box 587 Warsaw, Indiana 46581-0587
MAR - 4 2011
Re: K110145
Trade/Device Name: JuggerKnot" Soft Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 11, 2011 Received: February 14, 2011
Dear Ms. Wray:
We have reviewed your Section 510(k) premarket notification of-intent to-market the device referenced above ând 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, listing 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
3
Page 2 - Ms. Elizabeth Wray
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 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/Resourcesfor You/Industry/default.htm.
/www.fda.gov/MedicalDevices/ResourcesforYouIndustry/ucm.htm
Sincerely yours,
Aliz B. nute
for
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
KI10145 510(k) Number (if known):
Device Name: JuggerKnot™ Soft Anchors
Indications For Use:
The JuggerKnot™ Soft Anchors are intended for soft tissue to bone fixation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
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)
for M. Melkerson
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K110145
510(k) Number