(78 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fixation, with no mention of AI/ML terms or functionalities.
No
This device is for fracture fixation and realignment, not for treating or preventing diseases or conditions.
No
The device is a surgical implant intended for fixation and stabilization of bone segments or deformities. It does not perform any diagnostic functions like detecting, monitoring, or predicting diseases or conditions.
No
The device description clearly states it is a "non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fixation during the healing process of bone fractures and deformities (syndesmotic trauma, ankle fractures, hallux valgus). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is an implantable system (Suture Plate, Suture Assembly, Arrow Plate) used to physically stabilize bone segments. This is a medical device used in vivo (within the body), not in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended for fixation during the healing process for:
- . Syndesmotic trauma, such as syndesmosis disruptions in connection with Weber B and C ankle fractures.
- . Reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-201 metatarsal (IM) angle.
Product codes
HTN
Device Description
The KISSloc™ Suture System is a non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security. The suture is hooked around the Arrow Plate and passes through the two holes in the plate to form the entire assembly. This implant construct is intended to be used for fracture fixation between two bone segments and/or realignment and stabilization of an underlying skeletal (bony or soft tissue) deformity. Ancillary instruments required to aid in insertion of the KISSloc™ Suture System will be provided separately in a sterile disposable package. All implant components will also be provided in a sterile package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, 1st metatarsal, 201 metatarsal
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)
The following non-clinical testing was performed on the KISSloc™ Suture System and the comparable Biomet ToggleLoc System:
- Static tensile load to failure
The test report included demonstrates that the Arthrosurface KISSloc™ device outperformed the predicate device for the mechanical tests conducted.
No clinical data was provided in support of this substantial equivalency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2017
Arthrosurface, Inc. Ms. Dawn J. Wilson Vice President, Ouality and Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K170440
Trade/Device Name: KISSloc™ Suture 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: February 10, 2017 Received: February 14, 2017
Dear Ms. Wilson:
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 (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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/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.
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 Statement
510(k) Number (if known): K170440
Device Name: KISSloc™ Suture System
Indications for Use:
Intended for fixation during the healing process for:
- . Syndesmotic trauma, such as syndesmosis disruptions in connection with Weber B and C ankle fractures.
- . Reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-201 metatarsal (IM) angle.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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| 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
Tel: 508.520.3003
Fax: 508.528.4604 |
|----------------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Wilson
VP, Quality & Regulatory |
| Date of Preparation: | February 10, 2017 |
| Trade Name: | KISSloc™ Suture System |
| Common Name: | Plate & Suture System |
| Device: | Single/multiple component metallic bone fixation
appliances and accessories |
| Classification Regulation: | Regulation Number 888.3030 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | HTN |
Device Intended Use
Intended for fixation during the healing process for:
- Syndesmotic trauma, such as syndesmosis disruptions in connection with Weber B and C . ankle fractures.
- . Reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-200 metatarsal (IM) angle.
Device Description
The KISSloc™ Suture System is a non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security. The suture is hooked around the Arrow Plate and passes through the two holes in the plate to form the entire assembly. This implant construct is intended to be used for fracture fixation between two bone segments and/or realignment and stabilization of an underlying skeletal (bony or soft tissue) deformity. Ancillary instruments required to aid in insertion of the KISSloc™ Suture System will be provided separately in a sterile disposable package. All implant components will also be provided in a sterile package.
4
Substantial Equivalency:
The intended use, materials, and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices:
| • | Arthrosurface KISSloc™ Suture System | K133835 |
|---|---|---|
| • | Biomet ToggleLoc System (Ziptight) | K130033 |
| • | Arthrex Mini TightRope Repair Kit | K061925 |
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices:
- . Intended as adjuncts in fracture repair or for fixation of bone as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair
- . Similar indications for use
- Similar device designs
- Same Titanium and UHMWPE implant materials
The following non-clinical testing was performed on the KISSloc™ Suture System and the comparable Biomet ToggleLoc System:
- Static tensile load to failure
The test report included demonstrates that the Arthrosurface KISSloc™ device outperformed the predicate device for the mechanical tests conducted.
No clinical data was provided in support of this substantial equivalency.
The safety and effectiveness of using the KISSloc™ Suture System is adequately supported by the substantial equivalence and performance testing information provided within this Premarket Notification. Minor difference in device design and technique were determined not to be critical to the intended use of the device and do not affect the safety and effectiveness of the device when used as labeled.