(76 days)
Not Found
No
The summary describes a mechanical plating system for bone stabilization and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device aids in the repair of fractures, fusions, and osteotomies for small bones and bone fragments, which is a supportive rather than a therapeutic function directly treating disease.
No
The device is a plating system used to stabilize and aid in the repair of fractures, fusions, and osteotomies. It is a surgical implant, not a device used for diagnosis.
No
The device description explicitly states that the system consists of various size plates and screws, which are physical hardware components made from titanium alloy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Mini MaxLock Extreme® Plating System is described as a system of plates and screws used to physically stabilize and repair bones. These are implantable components used directly on the body during surgery.
- Intended Use: The intended use is to "stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments." This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly indicates this is a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Mini MaxLock Extreme® Plating System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured small bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and bone fragments
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)
Static mechanical testing and calculations comparing the bending and torsional strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, materials, and superior static testing performance, fatigue testing was not required. No new issues of safety and effectiveness have been raised.
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.
K063049, K050462, K083364, K073624
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.
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510(k) SUMMARY
Submitter Information Submitter's Name: OrthoHelix Surgical Designs, Inc. -Address: 1065 Medina Rd, Suite 500 Medina, Ohio 44256 SEP 2 7 2010 Telephone Number: 330-869-9562 Fax Number: 330-247-1598 Prepared By: Brian Hockett, Elizabeth Altenau Contact Person: Derek Lewis Date Prepared: 7/12/10 Device Information Trade Name: Mini MaxLock Extreme® Plating System Common Name: Fixation Plate Classification Name: Plate, Fixation, Bone Device Classification: Single/multiple component metallic bone fixation appliances (Class II per 21 CFR 888.3030) Panel: Orthopedic, Product Code: HRS Smooth or threaded metallic bone fixation fastener (Class II per 21 CFR 888.3040) Panel: Orthopedic, Product Code: HWC Predicate Device: The Mini MaxLock Extreme® Plating System is equivalent to current legally marketed devices. Material Composition: Titanium Alloy Device Description: The Mini MaxLock Extreme® Plating System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured small bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy. The Mini MaxLock Extreme® Plating System is intended to stabilize Intended Use: and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. The Mini MaxLock Extreme® Plating System is substantially equivalent Substantial Equivalence: to the Synthes Modular Mini Fragment LCP System (K063049), the Small Bone Innovations Hand Fracture System (K050462), the DePuy Orthopedic Small Bone Locking Plate System (K083364), and the OrthoHelix Modular Foot System (K073624). Static mechanical testing and calculations comparing the bending and torsional strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, materials, and superior static testing performance, fatigue testing was not required. No new issues of safety and effectiveness have been raised.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OrthoHelix Surgical Designs, Inc. % Mr. Derek Lewis 1065 Medina Road, Suite 500 Medina, Ohio 44256
SFP 2 7 2010
Re: K101962
Trade/Device Name: Mini MaxLock Extreme® Plating 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: September 13, 2010 Received: September 15, 2010
Dear Mr. Lewis:
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.
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
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Page 2 - Mr. Derek Lewis
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 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,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K101962
SEP 27 2010
510(k) Number (if known): K101962
Device Name: Mini MaxLock Extreme® Plating System
Indications for Use:
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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
Janette for mxn
(Division Sign off)
on of Surgical, Orthopedic, Divis and Restorative Devices
510(k) Number K101962