(300 days)
No
The summary describes a bone plate system for fracture fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a surgical implant designed for internal fixation of bone fractures, not a therapeutic device that delivers therapy or treatment.
No
The device is a surgical plate system used for internal fixation of bone tissue, specifically for fixing fractures of the distal radius. It is a treatment device, not a diagnostic one.
No
The device description clearly indicates it is a "Radius Plate System" used for "internal fixation by implants" and "stabilizing bone tissue," which are physical hardware components. The performance studies also describe testing of the "IXOS Radius Plate System" and "IXOS screws," further confirming it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for fixing bone fractures and performing osteotomies. This is a therapeutic and structural function within the body.
- Device Description: The description reinforces that it's a system for aligning, reconstructing, and stabilizing bone tissue, used in surgical procedures.
- 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 samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The IXOS Radius Plate System is intended for surgical procedures in which internal fixation by implants is required for aligning, reconstruction and stabilizing bone tissue.
It is used in particular for fixing intra- and extra articular acute fractures of the distal radius, in particularly
- · Type A2 Colles fractures
- · Type A3 fractures
- · Type B1 fractures
- · Type B2 Barton fractures
- · Type B3 Smith or reversed Barton fractures
- · Type C1 fractures
- · Type C2 fractures
- · Type C3 fractures
and in osteotomies of the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The IXOS Radius Plate System is used for aligning, reconstructing and stabilizing bone tissue. It is used in the field of hand, accident and reconstructive surgery and orthopedics especially for the fixation of acute distal intra- and extra-articular fractures of the radius.
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
surgical procedures / hand, accident and reconstructive surgery and orthopedics
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)
A static 4-point bending test as well as a dynamic 4-point bending test has been conducted with the IXOS Radius Plate System. IXOS screws have been tested according to ASTM F543-13. To compare the new device with the predicate device, the same tests were conducted for the predicate device. The comparison of the results shows that the new device IXOS Radius Plate System is substantially equivalent to the predicate device.
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.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 29, 2018
Stuckenbrock Medizintechnik GmbH Fabian Stuckenbrock President of Stuckenbrock Medizintechnik Lessingstraße 50 Tuttlingen, Baden-Wurttemberg, Germany 78532
Re: K171624
Trade/Device Name: IXOS Radius Plate 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: February 19, 2018 Received: February 22, 2018
Dear Fabian Stuckenbrock:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
IXOS Radius Plate System
Indications for Use (Describe)
The IXOS Radius Plate System is intended for surgical procedures in which internal fixation by implants is required for aligning, reconstruction and stabilizing bone tissue.
It is used in particular for fixing intra- and extra articular acute fractures of the distal radius, in particularly
- · Type A2 Colles fractures
- · Type A3 fractures
- · Type B1 fractures
- · Type B2 Barton fractures
- · Type B3 Smith or reversed Barton fractures
- · Type C1 fractures
- · Type C2 fractures
- · Type C3 fractures
and in osteotomies of the distal radius.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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DATE OF APPLICATION: 22.05.2017
APPLICANT:
Stuckenbrock Medizintechnik GmbH: Lessingstraße 50 78532 Tuttlingen Germany Tel: + 49 (0)7461/165880 Fax: +49 (0)7461/4194 E-Mail: verwaltung@stuckenbrock.de Internet: www.stuckenbrock.de
| CONTACT PERSON: | Fabian Stuckenbrock
President of Stuckenbrock Medizintechnik GmbH
Tel.: +49 (0)7461 165880
E-Mail: f.Stuckenbrock@stuckenbrock.de |
| ----------------- | -------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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Stuckenbrock Medizintechnik ein Unternehmen der KLS MOI CIN Group
1. Device Name
| Trade Name: | IXOS Radius Plate System |
|---|---|
| Common Name: | Bone fixation plate |
| Device Classification Name: | Single/multiple component metallic bone |
| fixation appliances and accessories |
2. Classification / Product Code
Stuckenbrock IXOS Radius Plate System can be classified according to following device name and product code:
| Device | Regulation
Description | Regulation
Medical
Specialty | Review
Panel | Product
Code | Regulation
Number | Device
Classificatio
n |
|--------------------------|-----------------------------------------------------------------------------------------|------------------------------------|-----------------|-----------------|----------------------|------------------------------|
| Plate, Fixation,
Bone | Single/multiple
component metallic
bone fixation
appliances and
accessories | Orthopedic | Orthopedic | HRS | 888.3030 | 2 |
3. Predicate Device / Reference Device
| Device | Predicate Device | Reference Device | 510(k)
Number | 510(k) Holder |
|-----------------------------|------------------------------------|----------------------------------------|------------------|----------------|
| IXOS Radius Plate
System | APTUS® Titanium
Fixation System | - | K051567 | Medartis, Inc. |
| | - | Zimmer Distal Radius
Plating System | K133246 | Zimmer, Inc. |
4. Device Description
The IXOS Radius Plate System is used for aligning, reconstructing and stabilizing bone tissue. It is used in the field of hand, accident and reconstructive surgery and orthopedics especially for the fixation of acute distal intra- and extra-articular fractures of the radius.
5. Indication for Use
The IXOS Radius Plate System is intended for surgical procedures in which internal fixation by implants is required for aligning, reconstructing and stabilizing bone tissue.
It is used in particular for fixing intra- and extra-articular acute fractures of the distal radius, particularly
- . Type A2 Colles fractures
- Type A3 fractures ●
- Type B1 fractures
- Type B2 Barton fractures
- Type B3 Smith or reversed Barton fractures ●
- Type C1 fractures .
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Stuckenbrock Medizintechnik ein Unternehmen der KLS MOITEIN Group
- Type C2 fractures ●
- Type C3 fractures ●
and in osteotomies of the distal radius
6. Equivalence to Marketed Product
The IXOS Radius Plate System is substantially equivalent to the already marketed predicate devices APTUS Titanium Fixation System (K051567) and Zimmer Distal Radius Plating System (K133246). The IXOS Radius Plate System is substantially equivalent in intended use, material, size and design.
7. Testing
Testing in order to proof safety and effectiveness of IXOS Radius Plate System has been performed according to recognized consensus standards and results are conforming to the respective requirements.
A static 4-point bending test as well as a dynamic 4-point bending test has been conducted with the IXOS Radius Plate System. IXOS screws have been tested according to ASTM F543-13. To compare the new device with the predicate device, the same tests were conducted for the predicate device. The comparison of the results shows that the new device IXOS Radius Plate System is substantially equivalent to the predicate device.
8. Biocompatibility
The IXOS Radius Plate System has been evaluated for its biological safety. Tests have been performed to proof the biocompatibility of the device.
9. Substantial Equivalence Summary / Conclusion
Based on available 510(k) information provided herein, Stuckenbrock IXOS Radius Plate System is considered to be substantially equivalent to the predicate device in terms if indication for use, material, technology, design and performance specifications. There are no differences between the devices which would raise new issues of safety or effectiveness.