(77 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, instruments) for fracture fixation and makes no mention of AI or ML.
Yes
The device is described as "intended to be used for the fixation of fractures and osteotomies," which directly addresses a medical condition (fractures) and provides a treatment (fixation). This aligns with the definition of a therapeutic device.
No
The device is described as an implantable system for the fixation of fractures and osteotomies, not for diagnosis.
No
The device description explicitly details physical components such as titanium plates, screws, and surgical instruments, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures and osteotomies involving the distal radius." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details plates, screws, and surgical instruments used for internal fixation. These are all physical implants and tools used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological or pathological state. This device does not interact with or analyze such specimens.
Therefore, based on the provided information, the Mondeal® DISTAL RADIUS System is a surgical implant system, not an IVD.
N/A
Intended Use / Indications for Use
The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.
Product codes
HRS
Device Description
The Mondeal® Distal Radius System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and configurations. Manual reusable surgical instruments may be supplied to facilitate implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
Indicated Patient Age Range
Not Found
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)
Not Found
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
Mondeal® Distal Radius System 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is Kon1798 . This Summary was prepared on August 27, 2007
GENERAL INFORMATION
Manufacturer and Applicant Information:
Mondeal Medical Systems GmbH Moltkestr. 39 Tuttlingen, GERMANY 78532 Contact: Jay Evans Telephone: 858-901-4123 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: 858-225-0311
Trade Name:
Device Name: Mondeal® Distal Radius System Common Name: Screw, Fixation, Bone and Plate, Fixation, Bone Classification Name: Plate, Fixation, Bone, Class II and Regulation: 21 CFR 888.3030, 87HRS
Substantial Equivalence:
Mondeal Medical Systems GmbH, claims substantial equivalence to the Mondeal® Radius HO System, K050655.
Indications for Use:
The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.
Description of the Device
The Mondeal® Distal Radius System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and configurations. Manual reusable surgical instruments may be supplied to facilitate implantation.
SEP 17 2007
1
ATTACHMENT III - 510(k) SUMMARY, REVISED
| Characteristic | Mondeal® Distal Radius System | Mondeal® Radius HO System |
|---|---|---|
| Names | Mondeal® Distal Radius System | Mondeal® Radius HO System |
| 510(k) number | TBD | K050655 |
| Indications for use | The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect. | The Mondeal® RADIUS HO System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect. |
| Design and Device Characteristics | ||
| Technology | Titanium plates and screws | Titanium plates and screws |
| Application | Internal Fixation of small bones of hand and foot | Internal Fixation of small bones of hand and foot |
| Design / Components | CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws | Ti-6Al-4V ELI Anodized Type II plates and screws |
| Performance Specifications | ||
| Corrosion resistance | Identical | Identical |
| Mechanical properties | Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content | Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content |
| Sterilisation Method | Steam Autoclave | Steam Autoclave |
| Packaging | Tempered plastic and or stainless steel trays suitable for steam sterilization including plate, screw, and hand tools (Class I) assortment, plates and screws also packaged individually, all non-sterils, intended for sterilization by purchaser | Tempered plastic and or stainless steel trays suitable for steam sterilization including plate, screw, and hand tools (Class I) assortment, plates and screws also packaged individually, all non-sterils, intended for sterilization by purchaser |
Device Comparison
Conclusions
Mondeal Medical Systems GmbH considers the Mondeal® DISTAL RADIUS System to be substantially equivalent to the aforementioned predicate devices with regard to intended use, materials, biocompatibility, and overall performance characteristics in accordance with the above comparison summary.
2
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 stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the left side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mondeal Medical Systems, GmbH % Mr. Jay Evans Mondeal North America, Inc. 13566 Freeport Road San Diego, California 92133
SEP 1 7 2007
Re: K071798
Trade/Device Name: Mondeal® Distal Radius 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: August 28, 2007 Received: September 4, 2007
Dear Mr. Evans:
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, RDA over 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
3
Page 2 - Mr. Jay Evans
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara buelin
for
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: _______________________________________________________________________________________________________________________________________________________________
Device Name: Mondeal® Distal Radius System
Indications For Use:
The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dalvara Buchen
(Division Sign-Off)
Division of Ge eral, Restorative. and Neurological Devices
510(k) Number K07196
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