(164 days)
No
The device description and performance studies focus on the mechanical properties and fixation strength of the anchors, with no mention of AI or ML.
No
The device is described as "soft tissue to bone fixation" for various repairs and reconstructions, which are surgical interventions, not therapeutic treatments.
No
The device is described as an implantable anchor for soft tissue to bone fixation, used in repair and reconstruction procedures. It is a therapy device, not a diagnostic one.
No
The device description clearly states it consists of a "coreless sleeve structure and suture," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "soft tissue to bone fixation" for various anatomical sites. This describes a surgical implant used to physically attach tissues, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a "coreless sleeve structure and suture" intended for "soft tissue fixation by bunching against bone when deployed." This is consistent with a surgical anchor, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
The device is a surgical implant used in orthopedic procedures.
N/A
Intended Use / 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, Pectoralis major repair
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, Medial Patellofemoral Ligament (MPFL) repair or reconstruction, Quadriceps tendon repair
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip: Acetabular labral repair, Proximal hamstring repair
The JuggerKnot Self-Punching Soft Anchors are intended for soft tissue to bone fixation for the following indications:
Shoulder: Rotator cuff tear repair
Foot and Ankle: Achilles tendon repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The JuggerKnot Soft Anchors consists 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, Elbow, Knee, Hand and Wrist, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 JuggerKnot Soft Anchors (K110145) for specific indications for use. The efficacy of the proposed JuggerKnot Soft Anchors was compared to that of the JuggerKnot Soft Anchors. The test results indicate that the JuggerKnot Soft Anchors achieved statistically equivalent or greater pullout strength to the predicate device and would be functional within their intended use.
Clinical Tests: None provided as a basis for substantial equivalence.
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.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corporation Adam Cargill Regulatory Affairs Specialist 56 East Bell Drive PO Box 587
September 22, 2015
Re: K150768
Warsaw, Indiana 46581
Trade/Device Name: JuggerKnot Soft Anchors, JuggerKnot Self-Punching Soft Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 28, 2015 Received: August 7, 2015
Dear Adam Cargill:
This letter corrects our substantially equivalent letter of September 4, 2015.
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, 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 comply with all the Act's requirements, including, but not limited to: registration and listing
1
Page 2 - Adam Cargill
(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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name JuggerKnot Soft Anchors
Indications for Use (Describe)
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, Pectoralis major repair
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, Medial Patellofemoral Ligament (MPFL) repair or reconstruction, Quadriceps tendon repair
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip: Acetabular labral repair, Proximal hamstring repair
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
K 150768 *An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
Device Name
JuggerKnot Self-Punching Soft Anchors
Indications for Use (Describe)
The JuggerKnot Self-Punching Soft Anchors are intended for soft tissue to bone fixation for the following indications:
Shoulder: Rotator cuff tear repair
Foot and Ankle: Achilles tendon repair
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image shows the word "BIOMET" in a simple, sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is a dark gray, and the background is white. The overall impression is clean and modern.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the JuggerKnot Soft Anchors 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Office: 574-267-6639
Main Fax: 574-267-8137
Establishment Registration Number: 1825034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Adam Cargill
Regulatory Affairs Specialist, Sports Medicine |
| Date: | September 17, 2015 |
| Subject Device: | Trade Name: JuggerKnot Soft Anchors
JuggerKnot Self-Punching Soft Anchor
Common Name: Soft Tissue Fixation Device
Classification Name:
• MBI- Fastener, Fixation, Non-degradable, Soft Tissue
(21 CFR 888.3040) |
Legally marketed devices to which substantial equivalence is claimed:
Device Description
The JuggerKnot Soft Anchors consists 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 and 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, Pectoralis major repair
5
Image /page/5/Picture/1 description: The image shows the word "BIOMET" in a simple, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. The word is presented in a straightforward, unadorned manner, with no additional design elements or embellishments.
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, Medial Patellofemoral Ligament (MPFL) repair or reconstruction, Quadriceps tendon repair
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip: Acetabular labral repair, Proximal hamstring repair
The JuggerKnot Self-Punching Soft Anchors are intended for soft tissue to bone fixation for the following indications:
Shoulder: Rotator cuff tear repair
Foot and Ankle: Achilles tendon repair
Summary of Technological Characteristics
The technological characteristics (materials, design, sizing, and indications) of the JuggerKnot Soft Anchors are similar or identical to the JuggerKnot Soft Anchors.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The JuggerKnot Soft Anchors are intended to reattached soft tissue to bone in orthopedic surgical procedures.
- . Indications for Use: The JuggerKnot Soft Anchors has the same indications for use as the predicate device, JuggerKnot Soft Anchors (K110145) for soft tissue to bone fixation with the addition of pectoralis major repair, medial patellofemoral ligament repair or reconstruction, proximal hamstring repair, and quadriceps tendon repair.
- Materials: The JuggerKnot Soft Anchors utilize the same materials as the predicate device.
- . Design Features: The JuggerKnot Soft Anchors incorporate the similar design features as the predicate device.
- . Sterilization: The JuggerKnot Soft Anchors are provided sterile via Ethylene Oxide, the same sterilization method used for the predicate device.
Summary of Performance Data (Nonclinical and/or Clinical)
6
BIOMET
- Non-Clinical Tests ●
- Non-clinical laboratory testing was performed to verify the fixation strength of o the JuggerKnot Soft Anchors in mechanical pullout testing as compared to the predicate JuggerKnot Soft Anchors (K110145) for specific indications for use. The efficacy of the proposed JuggerKnot Soft Anchors was compared to that of the JuggerKnot Soft Anchors. The test results indicate that the JuggerKnot Soft Anchors achieved statistically equivalent or greater pullout strength to the predicate device and would be functional within their intended use.
- . Clinical Tests
- None provided as a basis for substantial equivalence. o
Substantial Equivalence Conclusion
The proposed JuggerKnot Soft Anchors has similar intended use, technology characteristics, and mechanical performance as the predicate devices. The performance testing data identified no new risks and substantial equivalence to the legally marketed predicate device.