(47 days)
Not Found
No
The description focuses on mechanical components (plates and screws) for surgical fixation and mentions only mechanical performance testing. There is no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is intended for "stabilization and fixation of the 1st MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery," which describes a therapeutic purpose.
No
The device is described as an arthrodesis system consisting of bone plates and screws intended for surgical fusion of the 1st MTP joint, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of "anatomically contoured bone plates and screws," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is a system of bone plates and screws intended for surgical implantation to stabilize and fix the 1st MTP joint in the foot. This is a surgical implant used within the body.
- Intended Use: The intended use is for surgical procedures (fusion, osteotomy, etc.) on the 1st MTP joint. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a surgical implant system, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is intended for use in stabilization and fixation of the 1st MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System consists of anatomically contoured bone plates and screws which are intended to be used for surgical fusion (arthrodesis) of the 1st MTP joint. The plate is available in both left and right configurations. Locking, non-locking and interfragmentary screws are included as part of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
1st MTP joint in the foot
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)
Comparative static and dynamic four point bending test results, along with comparative dimensional analyses were used to support equivalence to predicate devices.
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
12 K113762 .
Section 5 510(k) Summary
| 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: | December 16, 2011 |
| Trade Name: | CheckMate™ Metatarso-Phalangeal (MTP)
Arthrodesis System |
| Common Name: | Arthrosurface Toe Plate System |
| Device: | Plate, fixation, bone |
| Classification Regulation: | Regulation Number 888.3030 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | HRS |
Device Intended Use
The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is intended for use in stabilization and fixation of the 155 MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery.
Device Description
The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System consists of anatomically contoured bone plates and screws which are intended to be used for surgical fusion (arthrodesis) of the 1st MTP joint. The plate is available in both left and right configurations. Locking, non-locking and interfragmentary screws are included as part of the system.
1
Image /page/1/Picture/0 description: The image contains a combination of alphanumeric characters. The string "K113762" is present, followed by a fraction-like expression, "2/2". The characters are handwritten and have a slightly rough, uneven appearance.
Substantial Equivalency:
The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices:
- DePuy ALPS Small Bone Locked Plating System K101240 t
- Arthrex Low Profile Plate and Screw System K052614 .
- Synthes 2.4 mm/2.7 mm Variable Angle (VA)-LCP K100776 . Forefoot/Midfoot System
Comparative static and dynamic four point bending test results, along with comparative dimensional analyses were used to support equivalence to predicate devices.
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
FEB - 6 2012
Arthrosurface, Inc. % Ms. Dawn Wilson 28 Forge Parkway Franklin, MA 02038
Re: K113762
Trade/Device Name: CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: December 16, 2011 Received: December 21, 2011
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 – Ms. Dawn Wilson
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for D.T.A.
Deplies
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 Statement Section 4
510(k) Number (if known): K113762
Device Name:
CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System
Indications for Use:
The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is intended for use in stabilization and fixation of the 1st MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery.
Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
(Part 21 CFR 801 Subpart D) AND/OR (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)
ਿੰਡ
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K113762