(118 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical hardware, with no mention of AI or ML.
No
The device is a surgical fixation system used to treat fractures and deformities, not to provide therapy.
No
The device is described as a surgical system for fracture fixation and reconstruction of small bones, which involves physically treating rather than diagnosing conditions.
No
The device description explicitly states it consists of bone plates and screws made from stainless steel, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- CheckMate™ System Function: The CheckMate™ Small Bone Fusion System is a surgical implant used for physically fixing and stabilizing bones during fracture repair, osteotomies, and other procedures. It is a mechanical device that is implanted directly into the body.
- Lack of Specimen Analysis: The description of the CheckMate™ system does not mention any analysis of biological specimens. Its function is entirely mechanical and structural.
Therefore, based on the provided information, the CheckMate™ Small Bone Fusion System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CheckMate™ Small Bone Fusion System is intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The CheckMate™ Small Bone Fusion System consists of 2-hole bone plates made available in three length options, and 2.0 mm and 2.7 mm diameter bone screws having lengths varying from 8 mm to 24 mm. The bone plate is pre-assembled with a suture . loop intended to provide a traction force required to achieve compression between bone segments. The bone screws have a snap-off feature designed to work with the plates and/or as standalone bone fixation fasteners. The bone plates and screws are manufactured from implant grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones in the upper and lower extremities.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative static and dynamic four-point bending test results, along with comparative dimensional and geometric 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.
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.
K111253, K090675, K071264, K063049, K051908
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
| 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: | July 30, 2012 |
| Trade Name: | CheckMate™ Small Bone Fusion System |
| Common Name: | Bone Plates and Screws |
| Device: | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Regulation Description: | Single/multiple component metallic bone fixation |
| appliances and accessories. | |
| Smooth or threaded metallic bone fixation fastener | |
| Regulation Number: | 888.3030 |
| 888.3040 | |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | HRS |
| HWC |
Intended Use
The CheckMate™ Small Bone Fusion System is intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.
1
Device Description
The CheckMate™ Small Bone Fusion System consists of 2-hole bone plates made available in three length options, and 2.0 mm and 2.7 mm diameter bone screws having lengths varying from 8 mm to 24 mm. The bone plate is pre-assembled with a suture . loop intended to provide a traction force required to achieve compression between bone segments. The bone screws have a snap-off feature designed to work with the plates and/or as standalone bone fixation fasteners. The bone plates and screws are manufactured from implant grade stainless steel.
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:
| • Arthrex, Inc.
| Distal Extremity Plate System | K111253 |
|---|---|
| • Smith & Nephew | |
| VLP Foot Plating, Screw System and Accessories | K090675 |
| • Synthes(USA) | K071264 |
| Synthes (USA) 2.4/2.7 mm Locking Foot Module | |
| Synthes (USA) Modular Mini Fragment LCP System | K063049 |
| • Wright Medical Technology, Inc. | |
| Charlotte™ Compression Plate | K051908 |
Comparative static and dynamic four-point bending test results, along with comparative dimensional and geometric 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 28, 2012
Arthrosurface, Incorporated % Ms. Dawn Wilson Vice President, Quality and Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K122334
Trade/Device Name: Checkmate Small Bone Fusion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 9, 2012 Received: November 13, 2012
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Dawn Wilson
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,
Ronald P. Jean for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 Indications for Use Statement
510(k) Number (if known): K122334
CheckMate™ Small Bone Fusion System Device Name: ·
Indications for Use:
The CheckMate™ Small Bone Fusion System is intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.
Prescription Use V (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)
Ronald P. Jean
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122334
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