(53 days)
Not Found
No
The summary describes a mechanical implant system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments, as well as fractures and osteotomies of the distal radius. These are therapeutic interventions.
No
Explanation: The device is a surgical implant (plating system) used to stabilize and aid in the repair of fractures, fusions, and osteotomies. It does not perform any diagnostic function.
No
The device description clearly states it is a modification to existing plating systems and describes physical components (polymer ring, locking screw) used in surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for stabilizing and aiding in the repair of fractures, fusions, and osteotomies of bones. This is a surgical/implantable device used directly on the patient's body.
- Device Description: The description details a system of plates, screws, and a polymer ring designed for bone fixation. This is consistent with a surgical implant.
- 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 for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not implanted within the body for structural support.
N/A
Intended Use / Indications for Use
The Mini Variable System, when used with 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.
The Mini Variable System, when used with the MaxLock Extreme® Distal Radius Plates and Screws, is intended for fractures and osteotomies of the distal radius in adult patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The submission is a modification to the Mini MaxLock Extreme® Plating System and MaxLock Extreme® Distal Radius Plates and Screws to add Mini Variable components. No modifications were made to the existing plates or screws - this addition will be compatible with all plates in the current systems. The OrthoHelix Mini Variable construct consists of a polymer ring which mates with the locking holes in a 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 and bone fragments, distal radius
Indicated Patient Age Range
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)
Calculations and mechanical testing comparing the bending and torsional strength of the subject and predicate devices were performed and the results support 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.
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
K III 041 (II)
JUN - 6 2011
510(k) SUMMARY
Submitter Information
Submitter's Name: Address:
Telephone Number: Fax Number: Prepared By: Contact Person: Date Prepared:
Device Information
Trade Name:
Common Name:
Classification Name:
Device Classification:
Material Composition:
Device Description:
Intended Use:
Substantial Equivalence:
OrthoHelix Surgical Designs, Inc. 1065 Medina Rd, Suite 500 Medina, Ohio 44256 330-869-9562 330-247-1598 Brian Hockett, Liz Altenau Derek Lewis 4/12/11
Mini Variable System
Fixation Plates and Screws
Plate, Fixation, Bone
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
Titanium Alloy, PEEK
The submission is a modification to the Mini MaxLock Extreme® Plating System and MaxLock Extreme® Distal Radius Plates and Screws to add Mini Variable components. No modifications were made to the existing plates or screws - this addition will be compatible with all plates in the current systems. The OrthoHelix Mini Variable construct consists of a polymer ring which mates with the locking holes in a plate and allows for a specially designed locking screw to be inserted at angles up to 15° in any direction while maintaining angular stability.
The Mini Variable System, when used with 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.
The Mini Variable System, when used with the MaxLock Extreme® Distal Radius Plates and Screws, is intended for fractures and osteotomies of the distal radius in adult patients.
The Mini Variable System is substantially equivalent to the OrthoHelix Mini MaxLock Extreme® Plating System Screws (K101962), the OrthoHelix MaxLock Extreme® Distal Radius Screws (K102156), The OrthoHelix MaxLock Extreme® System with Variable Angle Technology (K100618), and the Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System. Calculations and mechanical testing 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, and materials, no other testing was required. No new issues of safety and effectiveness have been raised.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized emblem featuring three curved lines that resemble an abstract representation of a human figure or a bird.
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
JUN - 6 2011
Re: K111041 Trade/Device Name: Mini Variable System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: May 20, 2011 Received: May 23, 2011
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
2
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/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.
Einc Keith
Jor Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Mini Variable System
Indications for Use:
The Mini Variable System, when used with 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.
The Mini Variable System, when used with the MaxLock Extreme® Distal Radius Plates and Screws, is intended for fractures and osteotomies of the distal radius in adult patients.
Prescription Use × 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)
Eric N. Keith
Page 1 of _1
Surgical, Orthopedic, and Restorative Devices
510(k) Number K111041