(110 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation and makes no mention of AI or ML capabilities.
Yes.
This device is described as a system of plates and screws used to "stabilize and aid in the fusion or repair of fractured bones and bone fragments," which directly addresses a health condition (fractures).
No
The device is described as a system of 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 "various size plates and screws" which are physical, implantable components made from titanium alloy or PEEK. This indicates it is a hardware-based medical device, not software-only.
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 description details plates and screws made of titanium alloy or PEEK, which are implantable components used for bone stabilization.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The MaxLock Extreme® System is an in vivo (inside the body) surgical implant.
N/A
Intended Use / Indications for Use
The MaxLock Extreme® System is indicated for the following:
- The 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 Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle.
- The Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients.
- The 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, 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)
Substantial equivalence was demonstrated with mechanical testing, finite element analysis and mathematical analyses. No new issues of safety and effectiveness have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K07362, K090289, K093900, K100618, K102156, K092528, K061400, K061098
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
JAN 3 0 2012
ﺔ ﺍﻟﺘ t
K 11 30 48
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: | Rebecca DiLiberto |
| Contact Person: | Derek Lewis |
| Date Prepared: | 1/19/12 |
| 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 is indicated for the following: |
| The 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 Clavicle Module is indicated for fractures, fusions and | |
| osteotomies of the clavicle and bones in the hand, wrist, foot and | |
| ankle.The Foot Module is indicated for fractures, fusions and | |
| osteotomies of bones in the hand, wrist, foot and ankle in | |
| pediatric and adult patients.The Distal Radius Module is indicated for fractures and | |
| osteotomies of the distal radius in adult patients. |
·
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Substantial Equivalence:
The MaxLock Extreme® System is substantially equivalent to previous versions of the MaxLock Extreme® System released under K-numbers: K07362, K090289, K093900, K100618, and K102156 as well as the Biomet Forerunner System (K092528), the OrthoHelix Calcaneal Trauma System (K061400) and the Biomet/E.B.I. OptiLock Periarticular Plating System (K061098). Substantial equivalence was demonstrated with mechanical testing, finite element analysis and mathematical analyses. No new issues of safety and effectiveness have been raised.
Page 2/2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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. Ohio 44256
JAN 3 0 2012
Re: K113048
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: January 3, 2012 Received: January 4, 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
3
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.
For Peter DV
N. Meller Der CC
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
4113.049 510(k) Number (if known):
Device Name: MaxLock Extreme® System
Indications for Use:
The MaxLock Extreme System is indicated for the following:
- The Universal Module is indicated for use in adult or pediatric patients as indicated for o 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 Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and o bones in the hand, wrist, foot and ankle.
- The Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, O wrist, foot and ankle in pediatric and adult patients.
- The Distal Radius Module is indicated for fractures and osteotomies of the distal radius in o adult patients.
Prescription Use X
AND/OR
Over-The-Counter-Use_
(Part 21 CFR 801 Subpart D)
(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)
Deale
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
(113048 510(k) Number