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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the JuggerKnot™ Mini Soft Anchors, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Mechanical Fixation	Equivalent fixation strength to predicate devices	"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."

Note: The document explicitly states "None provided as a basis for substantial equivalence" under "Clinical Testing." This indicates that biological safety and efficacy were demonstrated through non-clinical testing and comparison to predicate devices, rather than human trials.

Study Details

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The summary mentions "mechanical pullout testing" where the JuggerKnot™ Mini Soft Anchors were compared to two predicate devices. This implies a sample size of anchors for each device type subjected to the pullout test, but the exact number isn't quantified.
Data Provenance: The testing was "Non-clinical laboratory testing," indicating it was conducted in a controlled lab environment. The country of origin is not specified, but the applicant "Biomet Sports Medicine" is located in Warsaw, Indiana, USA, suggesting the testing likely occurred in the US or under US guidance. The testing is retrospective in the sense that it's performed on manufactured devices, not on living subjects over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of this device and study. The "ground truth" for non-clinical mechanical testing is typically established by engineering standards and validated testing protocols, not by expert consensus in the way clinical diagnostic image interpretation would be. The outcome (fixation strength) is objectively measured by testing equipment.

4. Adjudication Method for the Test Set

This question is not applicable. As the testing is mechanical and quantitative (fixation strength), there is no "adjudication" of expert opinions. The measurements from the mechanical tests are the primary data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases. This submission focuses on the mechanical performance of a soft tissue fixation device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is not an AI/algorithm-based diagnostic device. The "device" itself is a physical implant. The "standalone" performance here refers to the mechanical performance of the anchor itself when tested in a controlled laboratory setting. The non-clinical testing described is essentially demonstrating the "standalone" mechanical performance of the anchors.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical testing was objective mechanical measurements of fixation strength, as determined by standardized laboratory pullout tests.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a mechanical device. The device's design is based on engineering principles and similarity to predicate devices, not on machine learning from a dataset.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the reasons stated in point 8.

Summary

{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 ManagerVictor Rodgers / Director of Quality, Clinical, & Regulatory Affairs574-267-6639
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

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}------------------------------------------------

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

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

Regulation Number and Section

§ 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.