(59 days)
Not Found
No
The document describes a system of plates and screws for bone fixation and does not mention any AI or ML components or functionalities.
Yes
The device is used for internal fixation of fractured bones, which is a therapeutic intervention aimed at treating injuries and promoting healing.
No
The device is described as an internal fixation system (plates and screws) used to stabilize and aid in the fusion or repair of fractured bones, which is a therapeutic rather than a diagnostic function.
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.
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 bones to stabilize and aid in the fusion or repair of fractures and deformities. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as consisting of plates and screws made from implant grade materials, which are surgically implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and stabilization.
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 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
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, pediatric and adult 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 comparing the strength of the subject and predicate devices was performed and the results support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K122005
SEP 6 2012
li
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: | Andy Leither |
| Contact Person: | Derek Lewis |
| Date Prepared: | 7/6/12 |
| 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 | |
| Predicate Device: | The MaxLock Extreme® System is equivalent to current legally |
| marketed devices. | |
| 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 plates and screws are 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. |
1
- The MaxLock Extreme® Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.
The new MaxLock Extreme® System is substantially equivalent to the existing OrthoHelix MaxLock Extreme® System (K113048). Finite element analysis comparing the strength of the subject and predicate devices was performed and the results support 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..
Substantial Equivalence:
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 symbol to the right and text to the left. The symbol is a stylized representation of a human figure embracing a globe. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
OrthoHelix Surgical Designs, Incorporated % Mr. Derek Lewis Vice President of Research and Development 1065 Medina Road, Suite 500 Medina, OH 44256
Re: K122005
Trade/Device Name: MaxLock Extreme® System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances Regulatory Class: Class II Product Code: HRS, HWC Dated: August 9, 2012 Received: August 15, 2012
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 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
SEP : 6 2012
3
Page 2 - Mr. Derek Lewis
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/ReportalProblem/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 vours
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): K122005
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 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
Page 1 of 1
510(k) Number K122005