(53 days)
Not Found
No
The description focuses on mechanical components (plates and screws) and their use in fracture fixation. There is no mention of AI, ML, image processing, or data-driven analysis. The performance studies are based on finite element analysis and benchtop mechanical testing.
Yes.
The device is indicated for the fixation, fusion, and stabilization of fractured bones and bone fragments, which are therapeutic actions.
No
This device is a surgical fixation system (plates and screws) used to stabilize fractured bones, not to diagnose medical conditions. Its intended use is for internal fixation and repair, not for diagnostic purposes.
No
The device description explicitly states that the system consists of physical components (plates and screws) made from titanium alloy or PEEK, which are hardware implants.
Based on the provided information, 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 internal fixation of bone fractures and osteotomies. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as plates and screws made of titanium alloy or PEEK, which are materials used for surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used to physically stabilize bones.
N/A
Intended Use / Indications for Use
The MaxLock Extreme™ System is indicated for the following:
The MaxLock Extreme™ Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. The MaxLock Extreme™ Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. The MaxLock Extreme™ Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients. The MaxLock Extreme™ Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The MaxLock Extreme™ System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured 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 or PEEK.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic, small and long bone, tibia, fibula, femur, humerus, ulna, radius, hand, wrist, foot, ankle, clavicle, distal radius
Indicated Patient Age Range
Adult or pediatric patients, 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)
Finite element analysis was performed on the subject plating device and the predicate device to determine the worst case implant. Benchtop mechanical testing was performed to validate the results of the finite element analysis and to facilitate a comparison of the strength of the subject and predicate devices. The results support a determination of substantial equivalence. Further benchtop testing and calculations were performed on the subject screws to arrive at a determination of substantial equivalence.
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.
K123203, K073527, K092433, K101056, K082300, K012655
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
510(k) SUMMARY
| Submitter Information | |
|---|---|
| Submitter's Name: | OrthoHelix Surgical Designs, Inc. |
| Address: | 1065 Medina Rd, Suite 500 |
| Medina, Ohio 44256 | |
| Telephone Number: | 330-869-9562 |
| Fax Number: | 330-247-1598 |
| Prepared By: | Jackson Heavener |
| Contact Person: | Brian Hockett |
| Date Prepared: | 05/05/2014 |
| JUL 11 2014 | |
| Device Information | |
| Trade Name: | MaxLock Extreme™ System |
| Common Name: | Plates/Screws |
| Classification Name: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Device Classification: | Single/multiple component metallic bone fixation appliances |
| Class II per 21 CFR 888.3030 and 888.3040 | |
| Panel: Orthopedic, Product Code: HRS/HWC | |
| Material Composition: | Titanium Alloy, PEEK |
| Device Description: | The MaxLock Extreme™ System consists of various size plates and screws |
| used to stabilize and aid in the fusion or repair of fractured 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 or PEEK. | |
| Indications for Use: | The MaxLock Extreme™ System is indicated for the following: |
| The MaxLock Extreme™ Universal Module is indicated for use in adult | |
| or pediatric patients as indicated for pelvic, small and long bone | |
| fracture fixation and fixation of bones that have been surgically | |
| prepared (osteotomy) for correction of deformity or arthrodesis. | |
| Indications for use include internal fixation of the tibia, fibula, femur, | |
| humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. The MaxLock Extreme™ Clavicle Module is indicated for fractures, | |
| fusions and osteotomies of the clavicle and bones in the hand, wrist, | |
| foot and ankle. The MaxLock Extreme™ Foot Module is indicated for fractures, fusions | |
| and osteotomies of bones in the hand, wrist, foot and ankle in pediatric | |
| and adult patients. The MaxLock Extreme™ Distal Radius Module is indicated for fractures | |
| and osteotomies of the distal radius in adult patients. | |
| Substantial Equivalence: | The new MaxLock Extreme™ System is substantially equivalent to the |
| existing OrthoHelix MaxLock Extreme™ System, Universal Module | |
| (K123203) as well as Stryker VariAx Elbow System (K073527, K092433 & |
.
:
1
K101056) the Depuy Orthopaedics, Anatomic Locking Plating System (K082300) and the Acumed Congruent Bone Plating System (K012655). Finite element analysis was performed on the subject plating device and the predicate device to determine the worst case implant. Benchtop mechanical testing was performed to validate the results of the finite element analysis and to facilitate a comparison of the strength of the subject and predicate devices. The results support a determination of substantial equivalence. Further benchtop testing and calculations were performed on the subject screws to arrive at a determination of substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002
July 11, 2014
OrthoHelix Surgical Designs, Incorporated Mr. Brian Hockett Director of Research and Development 1065 Medina Road, Suite 500 Medina, Ohio 44256
Re: K141301
Trade/Device Name: MaxLock Extreme™ 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: May 2, 2014 Received: May 19, 2014
Dear Mr. Hockett:
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 - Mr. Brian Hockett
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
hup://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 yours,
Ronald P. Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K141301
Device Name: MaxLock Extreme™ System
Indications for Use:
The MaxLock Extreme System™ is indicated for the following:
•The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
• The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.
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)
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Division of Orthopedic Devices
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