(85 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of bone fixation plates and screws, with no mention of AI or ML.
No
The device is described as a set of implantable bone fixation plates and screws used to treat fractures, fusions, and osteotomies. While it aids in healing and improving function, its primary role is structural fixation, not direct therapeutic action like drug delivery or energy modulation. It's a surgical implant rather than a therapeutic device in the sense of actively treating a condition through a specific mechanism like stimulating tissue growth or reducing pain.
No
The device is described as a set of implantable bone fixation plates and screws used for fractures, fusions, and osteotomies. Its intended use is for treatment and repair, not for diagnosing a condition or disease.
No
The device description explicitly states it is a set of metallic, implantable bone fixation plates and screws, along with surgical instruments. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Modular Foot System is a set of "metallic, implantable, bone fixation plates and screws" used for "fractures, fusions and osteotomies for small bones." These are surgical implants and instruments used directly on the patient's body during a procedure.
- Intended Use: The intended use is to fix bones, not to analyze samples from the body.
Therefore, based on the provided information, the Modular Foot System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Modular Foot System is indicated for fractures, fusions and osteotomies of the hand, wrist, foot and ankle in pediatric and adult patients.
Product codes
HRS
Device Description
The OrthoHelix Modular Foot System is a set of metallic, implantable, bone fixation plates and screws. The System includes 26 fixation plates and 66 screws, which include all different sizes. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti-6Al-4V ELI per ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, foot and ankle
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
Finite Element Analysis, mechanical testing and hand calculations all confirm that the implants within the Modular Foot System are substantially equivalent to its predicate devices, and that it meets the specified requirements for its intended use.
Key Metrics
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
K073624 * 1/2
OrthoHelix Surgical Designs, Inc.
Modular Foot System
510(k) Premarket Notification
MAR 2 0 2008
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
OrthoHelix Surgical Designs, Inc. 1815 W. Market Akron, Ohio 44313 Phone: (330) 869-9582 Fax: (330) 869-9583
Contact Person: Derek Lewis Director of Engineering
Date Prepared: 12/17/07
Name of Device
Modular Foot System
Common or Usual Name
Fixation Plates and Screws
Classification Name
Plate, Fixation, Bone
Predicate Devices
Darco Locking Bone Plate System (K061808) OrthoHelix MaxLock Small Bone System (K050868)
Intended Use
The Modular Foot System is indicated for fractures, fusions and osteotomies of the hand, wrist, foot and ankle in pediatric and adult patients.
1
X073604 = 0/0
OrthoHelix Surgical Designs, Inc.
510(k) Premarket Notification
Modular Foot System
Device Description
The OrthoHelix Modular Foot System is a set of metallic, implantable, bone fixation plates and screws. The System includes 26 fixation plates and 66 screws, which include all different sizes. It also includes various surgical instruments such as drill guides, drill bits and drivers. All screws and plates are made from implant grade titanium, Ti-6Al-4V ELI per ASTM F-136.
Performance Data
Finite Element Analysis, mechanical testing and hand calculations all confirm that the implants within the Modular Foot System are substantially equivalent to its predicate devices, and that it meets the specified requirements for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and a ribbon flowing from its beak. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Orthohelix Surgical Designs, Inc. % Mr. Derek Lewis 1815 W. Market Akron, OH 44313
MAR 2 0 2008
K073624 Re: Trade/Device Name: Modular Foot 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 Dated: March 6, 2008 Received: March 6, 2008
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 such 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); 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.
3
Page 2 - Mr. Lewis
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Marti M Millen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): TBD
Device Name: Modular Foot System
Indications for Use:
The Modular Foot System is indicated for the fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
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)
Page _ of
Division of General, Restorative, and Neurological Devices
K073624 510(k) Number_