(67 days)
Not Found
No
The summary describes a mechanical suture-based system for fracture stabilization and does not mention any AI/ML components or functions.
No
The device is a suture-based construct intended to stabilize fractures in the foot and ankle, which falls under surgical repair rather than providing a therapeutic effect like pain relief or functional restoration through non-interventional means.
No
The device is described as a 'suture based construct intended to stabilize fractures,' and its intended use is for 'repair in the foot and ankle.' It is a therapeutic device used for treatment, not for identifying or diagnosing a condition.
No
The device description clearly states it is a "suture based construct" consisting of "suture and metal button fixation," indicating it is a physical medical device, not software.
Based on the provided information, the Biomet JuggerLoc™ Bone system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "repair in the foot and ankle including indications for: Midfoot repair... ankle syndesmosis fixation... and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures." This describes a surgical implant used to stabilize fractures and repairs within the body.
- Device Description: The description details a "suture based construct intended to stabilize fractures" consisting of a "JuggerKnot Soft Anchor with ZipLoop Technology, featuring combinations of suture and metal button fixation." This is a physical device implanted during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Performing tests outside of the body (in vitro)
IVDs are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The Biomet JuggerLoc™ Bone system is a therapeutic device used to physically repair and stabilize bone structures within the body.
N/A
Intended Use / Indications for Use
The JuggerLoc Bone to Bone System is intended for repair in the foot and ankle including indications for: Midfoot repair including but not limited to Lisfranc repair, ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The new JuggerLoc Bone to Bone system is a suture based construct intended to stabilize fractures. The construct consists of a JuggerKnot Soft Anchor with ZipLoop Technology, featuring combinations of suture and metal button fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle
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)
Performance Test Summary - New Device The JuggerLoc Bone to Bone System components have the same basic technological and material characteristics as the predicate devices except for slight modifications to the general design as described in this 510(k) notification. Preclinical performance tests are provided to address the subject construct's strength. A biocompatibility rationale was also provided. Results indicate that the subject construct is substantially equivalent to legally marketed devices.
Clinical Performance Data/Information: 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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JUL 1 8 2014
Section 5 - 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell Drive |
| P.O. Box 587 | |
| Warsaw, IN 46581 | |
| Phone number | (574) 372-1941 |
| Fax number | (574) 371-1027 |
| Establishment | 1825034 |
| Registration Number | |
| Name of contact person | Jared Cooper |
| Regulatory Affairs Specialist | |
| Date prepared | 29 April 2014 |
| Name of device | |
| Trade or proprietary name | JuggerLoc Bone to Bone System |
| Common or usual name | Bone Fixation Anchor |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories. |
| Classification panel | Orthopedics |
| Regulation | 21 CFR § 888.3030 |
| Product Code(s) | HTN - washer, bolt nut |
| Legally marketed device(s) to which equivalence is claimed | K130033 - Biomet ToggleLoc System |
| K110145 - Biomet JuggerKnot Soft Anchors | |
| K133275 - Arthrex Mini-Tightrope | |
| Reason for 510(k) submission | New Device Construct |
| Device description | The new JuggerLoc Bone to Bone system is a suture based construct intended to stabilize fractures. The construct consists of a JuggerKnot Soft Anchor with ZipLoop Technology, featuring combinations of suture and metal button fixation. |
| Indications for use | The JuggerLoc Bone to Bone System is intended for repair in the foot and ankle including indications for: |
| Midfoot repair including but not limited to Lisfranc repair, ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures. | |
| Summary of the Technologies |
The technological characteristics of the JuggerLoc Bone to Bone System are similar to the predicate devices including design, dimensions, function, and materials. The JuggerLoc design differs from the predicate devices by having one soft anchor and one metal button to achieve fixation rather than two metal buttons.
1
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Performance Test Summary - New Device
The JuggerLoc Bone to Bone System components have the same basic technological and material characteristics as the predicate devices except for slight modifications to the general design as described in this 510(k) notification. Preclinical performance tests are provided to address the subject construct's strength. A biocompatibility rationale was also provided. Results indicate that the subject construct is substantially equivalent to legally marketed devices.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of preclinical tests and the similarities with legally marketed devices indicate the JuggerLoc Bone to Bone System is substantially equivalent to currently marketed devices. No new concerns of safety or efficacy have been raised.
2
Public Health Service
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2014
Biomet Manufacturing Corp. Dr. Jared Cooper Regulatory Affairs Specialist 56 East Bell Drive. PO Box 587 Warsaw, Indiana 46581
Re: K141219
Trade/Device Name: JuggerLoc TM Bone to Bone System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: May 23, 2014 Received: May 27, 2014
Dear Dr. Cooper:
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 docs 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 cither 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
3
Page 2 - Dr. Jared Cooper
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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" (21 CFR 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/ReportalProblem/default.hun 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiaqins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use Statement
K141219 510(k) Number:
JuggerLoc™ Bone to Bone System Device Name:
Indications For Use:
The Biomet JuggerLoc™ Bone system is intended for repair in the foot and ankle including indications for:
Midfoot repair including but not limited to Lisfranc repair, ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.
× Prescription Use_ (Per 21 CFR 801 Subpart D) AND/OR Over-the-Counter_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth 臨歐ank -S
Division of Orthopedic Devices