(125 days)
Not Found
No
The description focuses on the mechanical design and function of a soft tissue anchor, with no mention of AI or ML capabilities.
Yes
The device is described as an implantable Soft Anchor intended for soft tissue reattachment procedures to treat various orthopedic conditions, which is consistent with the definition of a therapeutic device.
No
Explanation: The device is described as soft anchors for soft tissue reattachment and fixation procedures, not for diagnosing conditions or diseases.
No
The device description clearly states it consists of a "coreless sleeve structure and a knotless construct incorporating ZipLoop™ Technology," 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 that the device is for "soft tissue reattachment procedures" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device ("coreless sleeve structure and a knotless construct") used for "soft tissue fixation by bunching against bone when deployed." This is a mechanical function within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health, diagnosis, or condition.
IVD devices are used in vitro (in glass, or outside the body) to analyze biological samples. This device is used in vivo (in the living body) for surgical repair.
N/A
Intended Use / Indications for Use
The JuggerKnotless™ Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:
Shoulder
Acromio-clavicular Separation, Anterior Shoulder Instability Repair, Bankart lesion repair, Biceps tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle
Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs
Elbow
Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collament Reconstruction
Knee
Iliotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist
Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Volar Plate Reconstruction
- Hip
Labral
Product codes
MBI, JDR
Device Description
The JuggerKnotless™ Soft Anchors consist of a coreless sleeve structure and a knotless construct incorporating ZipLoop™ Technology. 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, and 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
Non-clinical laboratory testing was performed to verify the fixation strength of the JuqgerKnotless™ Soft Anchors in mechanical pullout testing as compared to the predicate devices for specific indications for use. The efficacy of the JuggerKnotless™ Soft Anchors was compared to that of the Biomet Sports Medicine 2.4mm PEEK Hitch Anchor. The test results indicate that the Biomet Sports Medicine JuggerKnotless™ Soft Anchors provide equivalent fixation strength to the predicate devices and would be functional within their intended use.
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
K123485 (1/2)
Image /page/0/Picture/1 description: The image shows the logo for Biomet Sports Medicine. The word "BIOMET" is in a bold, outlined font on the top line. Below that, the words "SPORTS MEDICINE" are in a smaller, regular font.
510(k) Summary
MAR 1 8 2013
October 31, 2012 Preparation Date:
Applicant/Sponsor: Biomet Sports Medicine
Contact Person: Elizabeth Wray / Global RA Project Manager (574)-267-6673
JuggerKnotless™ Soft Anchors Proprietary Name:
Common Name: Soft Tissue Fixation Device
Classification Name: Fastener, fixation, nondegradable, soft tissue (21CFR &88.3040) MBI Staple, fixation, bone (21CFR §888.3030) JDR
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
K080088 Biomet Sports Medicine Anchor Devices and ZipLoop™ Constructs K110145 JuggerKnot™ Soft Anchors
Device Description:
The JuggerKnotless™ Soft Anchors consist of a coreless sleeve structure and a knotless construct incorporating ZipLoop™ Technology. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
Intended Use / Indications for Use:
The JuggerKnotless™ Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:
Shoulder
Acromio-clavicular Separation, Anterior Shoulder Instability Repair, Bankart lesion repair, Biceps tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle
Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs
Elbow
Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Mailing Address
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
1
Knee
Iliotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist
Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Volar Plate Reconstruction
- Hip
Labral
Summary of Technologies:
The technological characteristics (materials, design, sizing and indications) of the JuggerKnotless™ 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 JuqgerKnotless™ Soft Anchors in mechanical pullout testing as compared to the predicate devices for specific indications for use. The efficacy of the JuggerKnotless™ Soft Anchors was compared to that of the Biomet Sports Medicine 2.4mm PEEK Hitch Anchor. The test results indicate that the Biomet Sports Medicine JuggerKnotless™ 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
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
Biomet Sports Medicine % Ms. Elizabeth Wray Senior Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581
Re: K123485
Trade/Device Name: JuggerKnotless™ Soft Anchors Regulation Number: 21 CFR 888.3040, 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener, Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MBI, JDR Dated: February 25, 2013 Received: February 26, 2013
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.
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
3
Page 2 - Ms. Elizabeth Wray
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 vours.
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): __K123485
Device Name: JuggerKnotless™ Soft Anchors
Indications For Use:
The JuqqerKnotless™ Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:
Shoulder
Acromio-clavicular Separation, Anterior Shoulder Instability Repair, Bankart lesion repair, Biceps tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle
Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs
Elbow
Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondy/itis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee
Iliotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Liqament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist
Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Volar Plate Reconstruction
Hip
Labral
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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)
| Casey L. Hanley Ph.D. |
|---|
| Division of Orthopaedic Devices |
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