(47 days)
Not Found
No
The 510(k) summary describes a mechanical device (plates and screws) with a variable angle locking mechanism. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device, consisting of plates and screws for fractures, fusions, and osteotomies, is used to treat medical conditions (injuries and skeletal deformities), classifying it as a therapeutic device.
No
The device, a variable angle locking screw construct for orthopedic plates, is intended for treating fractures, fusions, and osteotomies. It is an implant used in treatment, not for diagnosing conditions.
No
The device description clearly describes physical implants (plates and screws) and mechanical testing, indicating it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment of fractures, fusions, and osteotomies in bones. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a surgical implant (plates and screws) designed to provide stability to bones. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.
Product codes
HRS
Device Description
This special 510(K) submission is a modification to the previously cleared Modular Foot and Clavicle systems to add a variable angle locking screw construct. No changes have been made to the current locking plates; this addition will be compatible with all plates currently in the system. The OrthoHelix variable angle construct consists of a polymer ring which mates with the locking plate and allows for a specially designed locking screw to be inserted at angles up to 15° in any direction while maintaining angular stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones in the hand, wrist, foot and ankle, clavicle
Indicated Patient Age Range
pediatric and adult patients.
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)
Dynamic and static mechanical testing confirm that the MaxLock Extreme® implants with Variable Angle Technology are substantially equivalent to their predicate and meet the specified requirements for their intended use. No new issues of safety and efficacy have been raised during the development of this system.
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
APR 2 0 2010
KI00618 (1)2)
510(K) Summary of Safety and Effectiveness MaxLock Extreme® Extremity Plating System with Variable AngleTechnology
Class II
Proprietary Name:
MaxLock Extreme Extremity Plating System with Variable Angle Technology
888.3030 - Single/multiple component metallic
HRS - Single/multiple component metallic bone
bone fixation appliances and accessories
fixation appliances and accessories
Common Name:
Bone Fixation Screws
Classification Name and Reference:
Regulatory Class:
Device Product Code:
Contact Information:
Derek Lewis Vice-President of Research and Development OrthoHelix Surgical Designs Inc. 1065 Medina Rd., Suite 500 Medina. OH 44256 Phone: 330 869-9562 Fax: 330 247-1598 E-Mail: dlewis@orthohelix.com
Summary Date:
April 15, 2010
Device Description
This special 510(K) submission is a modification to the previously cleared Modular Foot and Clavicle systems to add a variable angle locking screw construct. No changes have been made to the current locking plates; this addition will be compatible with all plates currently in the system. The OrthoHelix variable angle construct consists of a polymer ring which mates with the locking plate and allows for a specially designed locking screw to be inserted at angles up to 15° in any direction while maintaining angular stability.
1
Intended Use
Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.
Substantial Equivalence
The MaxLock Extreme® Extremity Plating System with Variable Angle Technology is substantially equivalent to currently marketed devices, the OrthoHelix Modular Foot System (K073624) and Clavicle Plating System (K090289) and the Stryker VariAx System (K060613). The new technology is a modification to the OrthoHelix Modular Foot System, K073624 and Clavicle Plating System, K090289. The new technology only differs from the predicate devices with inclusion of a polymer locking ring and a specially designed locking screw to facilitate a variable angle locking mechanism.
Dynamic and static mechanical testing confirm that the MaxLock Extreme® implants with Variable Angle Technology are substantially equivalent to their predicate and meet the specified requirements for their intended use. No new issues of safety and efficacy have been raised during the development of this system.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
APR 2 0 2010
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 Vice President of Research and Development 1065 Medina Road, Suite 500 Medina, Ohio 44256
Re: K100618
Trade/Device Name: MaxLock Extreme® Extremity Plating System with Variable Angle Technology Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II Product Code: HRS Dated: April 5, 2010 Received: April 6, 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. 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
3
Page 2 - Mr. Derek Lewis
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 (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/CDRH0ffices/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.
Barbara buchner
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
510(k) Number (if known): ID KIOO6 18
Device Name: MaxLock Extreme Extremity Plating System with Variable Angle Technology
Indications for Use:
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Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.
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)
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(Division Sign-off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number _