JuggerKnot Soft Anchors
Device Facts
| Record ID | K150768 |
|---|---|
| Device Name | JuggerKnot Soft Anchors |
| Applicant | Biomet Manufacturing Corp |
| Product Code | MBI · Orthopedic |
| Decision Date | Sep 4, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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
Device Story
JuggerKnot Soft Anchors consist of coreless sleeve structure and suture; designed for soft tissue-to-bone fixation. Device functions by bunching against bone upon deployment. Used by orthopedic surgeons in clinical settings for various ligament and tendon repairs. Output is mechanical fixation of soft tissue to bone; aids in surgical reconstruction and repair. Benefits include secure tissue attachment to bone to facilitate healing. No electronic or software components.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by non-clinical bench testing (mechanical pullout strength) comparing subject device to predicate.
Technological Characteristics
Coreless sleeve structure with suture. Materials identical to predicate. Sterilization via Ethylene Oxide.
Indications for Use
Indicated for patients requiring soft tissue to bone fixation in orthopedic surgical procedures of the shoulder, foot, ankle, elbow, knee, hand, wrist, and hip.
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.
Predicate Devices
Submission Summary (Full Text)
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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
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## 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
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# Indications for Use
510(k) Number (if known)
K150768
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)
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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### *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:
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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."
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# Indications for Use
510(k) Number (if known)
K150768
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."
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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.<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Office: 574-267-6639<br>Main Fax: 574-267-8137<br>Establishment Registration Number: 1825034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Adam Cargill<br>Regulatory Affairs Specialist, Sports Medicine |
| Date: | September 17, 2015 |
| Subject Device: | Trade Name: JuggerKnot Soft Anchors<br>JuggerKnot Self-Punching Soft Anchor<br>Common Name: Soft Tissue Fixation Device<br>Classification Name:<br>• MBI- Fastener, Fixation, Non-degradable, Soft Tissue<br>(21 CFR 888.3040) |
### Legally marketed devices to which substantial equivalence is claimed:
- Biomet JuggerKnot Soft Anchors (K110145)
- Arthrex Pec Button (K123341)
### 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
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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)
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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.
