(108 days)
No
The document describes a traditional plating system for bone fixation and does not mention any AI or ML components.
Yes
The device is described as a plating system intended for the stabilization and fixation of fractures and for use in procedures like joint fusion and reconstruction of small bones. These applications directly contribute to restoring function and health, which aligns with the definition of a therapeutic device.
No
This device is a plating system used for the stabilization and fixation of bones after fractures or during reconstructive procedures. It is a treatment device, not one that gathers information about a patient's condition to make a diagnosis.
No
The device description clearly states it is a "Plating System" made of Ti6Al4V, which are physical implants (plates and screws) used for bone fixation. This is a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the RIVAL™ View Plating System™ and Reduce Fracture Plating System™ are for the stabilization and fixation of bones in the hand, feet, wrist, ankles, fingers, and toes. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as plates and screws made of Ti6Al4V, which are materials used for surgical implants.
- 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 outside the body to analyze samples, while this device is an implant used inside the body for structural support.
N/A
Intended Use / Indications for Use
RIVAL™ View Plating System™ and Reduce Fracture Plating System™ are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with Rival locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
Examples of these procedures for which the RIVAL™ View Plating Systems™ may be used, but are not limited to:
- First metatarsal osteotomies for hallux valgus correction including:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
- First metatarsal fracture fixation
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux rigidus and/or hallux valgus
- Revision MTP Fusion
- Revision of failed first MTP Arthroplasty Implant
- Calcaneal-Cuboid Fusion
- Talonavicular Fusion
- Evans Osteotomy
Example of indications for which the RIVAL™ Reduce Plating Systems™ may be used, but are not limited to:
- Metatarsal or metacarpal fractures and osteotomies
- Phalanges fractures and osteotomies
- Lapidus Fusion
- Lisfranc Arthrodesis
- 1st MPJ Arthrodesis
- Forefoot osteotomies
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
RIVAL™ View Plating System™ and Reduce Fracture Plating System™ has been designed to support multiple indications within the forefoot and mid-foot. The Subject device introduces new line extension codes, in sterile and non-sterile configuration. Subject device is manufactured by the same material (Ti6Al4V) and by the same manufacturer Orthofix Srl as the predicate EDGE Orthopaedics VIEW and REDUCE Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand, feet, wrist, ankles, fingers and toes, forefoot and mid-foot
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)
Subject device has similar configuration, material, sizes and design as the predicate devices. Mechanical performance and engineering assessment with worst case of subject device and corresponding predicate devices, confirm that subject devices have equivalent or better strength and resistance. Any potential hazard have been evaluated and controlled through Risk Management activities. The review of clinical literatures on similar devices still support the clinical data of the Subject devices with no additional clinical information. Pyrogenicity testing was conducted in support of 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.
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). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 7, 2019
Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 24408
Re: K190388
Trade/Device Name: RIVAL View Plating Systems and Reduce Fracture Plating Systems 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: February 8, 2019 Received: February 19, 2019
Dear Cheryl Wagoner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190388
Device Name
RIVAL™ View Plating System™ and Reduce Fracture Plating System™
Indications for Use (Describe)
RIVAL™ View Plating System™ and Reduce Fracture Plating System™ are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with Rival locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
Examples of these procedures for which the RIVAL™ View Plating Systems™ may be used, but are not limited to:
- · First metatarsal osteotomies for hallux valgus correction including:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
- First metatarsal fracture fixation
- · Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- · Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux rigidus and/or hallux valgus
- Revision MTP Fusion
- Revision of failed first MTP Arthroplasty Implant
- · Calcaneal-Cuboid Fusion
- · Talonavicular Fusion
- · Evans Osteotomy
Example of indications for which the RIVAL™ Reduce Plating Systems™ may be used, but are not limited to:
- · Metatarsal or metacarpal fractures and osteotomies
- Phalanges fractures and osteotomies
- · Lapidus Fusion
- · Lisfranc Arthrodesis
- · 1st MPJ Arthrodesis
- · Forefoot osteotomies
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) K190388
510(k) Summary
A 510(k) Summary of the safety and effectiveness information upon which this substantial equivalence determination is based, is provided in this section.
510(k) Summary
(21 CFR 807.92)
Submitter information
| Submitter Name | Orthofix Srl |
|---|---|
| Address | Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| Contact Person | Gianluca Ricadona
Sr. Quality & Regulatory Affairs Manager |
|----------------|---------------------------------------------------------------|
| Address | Via delle Nazioni, 9
37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719 000 |
| Fax | + 39 045 6719 380 |
| email | GianlucaRicadona@orthofix.it |
| Date Prepared | June 7, 2019 |
Trade Name, Common Name, Classification
| Trade Name | RIVAL™ View Plating System™ and Reduce Fracture Plating
System™ |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name | Plating System |
| Panel Code | Orthopedic |
| Class | Class II |
| Classification Name and
Product code | Plate, Fixation, Bone (21 CFR 888.3030, Product Code HRS)
Screw, Fixation, Bone (21 CFR 888.3040, Product Code HWC) |
Predicate device
| Predicate Device | 510(k) Number | Manufacturer |
|---|---|---|
| Primary Predicate | ||
| EDGE Orthopaedics VIEW and | ||
| REDUCE Plating Systems | K140876 | ORTHOFIX SRL |
| Reference device | ||
| Orthopaedics REDUCE Fracture | ||
| Plating System Line Extension | K142135 | ORTHOFIX SRL |
| Device description | RIVAL™ View Plating System™ and Reduce Fracture Plating
System™ has been designed to support multiple indications within
the forefoot and mid-foot. The Subject device introduces new line
extension codes, in sterile and non-sterile configuration.
Subject device is manufactured by the same material (Ti6Al4V) and
by the same manufacturer Orthofix Srl as the predicate EDGE
Orthopaedics VIEW and REDUCE Plating System. |
| -------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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Additional Information (AI) to the 510(k) K190388
| Indications for use | As the predicate EDGE Orthopaedics VIEW and REDUCE Plating
System, the Subject device are intended for use in stabilization and
fixation of fresh fractures, revision procedures, joint fusion, and
reconstruction of small bones of the hand, feet, wrist, ankles, fingers
and toes. The plates are available for use with Orthofix locking and
non-locking bone screws.
Plates and screws are intended for single use only. Screws are not
intended for use in the spine.
Examples of these procedures for which the Rival View Plating
System may be used, but are not limited to:
• First metatarsal osteotomies for hallux valgus correction including:
- Opening base wedge osteotomy
-Closing base wedge osteotomy - Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
• First metatarsal fracture fixation
• Arthrodesis of the first metatarsal-cuneiform joint (Lapidus Fusion)
• Arthrodesis of the first metatarsophalangeal joint (MTP) including:
Primary MTP Fusion due to hallux ridgidus and/or hallux valgus |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Revision MTP Fusion - Revision of failed first MTP Arthroplasty Implant
• Calcaneal-Cuboid Fusion
• Talonavicular Fusion
• Evans Osteotomy
Example of indications for which the Rival Reduce Fracture Plating
System may be used, but are not limited to: |
| | • Metatarsal or metacarpal fractures and osteotomies
• Phalanges fractures and osteotomies
• Lapidus Fusion
• Lisfranc Arthrodesis
• 1st MPJ Arthrodesis
• Forefoot osteotomies |
| Technological
Characteristics and
Intended Use | The fundamental scientific principles and technological characteristic,
including the intended use, material and general design are the same
as, or similar to, the predicate devices. Summary of the technological
characteristics:
✓ Plate thickness, geometry and width(s) are identical to the
predicates.
✓ Range of plate angles are identical to predicates.
✓ Identical material (Titanium Alloy) to the cited predicates
✓ Locking and non-locking screws same as the predicates,
✓ Sterile method, same as the predicates
✓ Indications for Use and anatomical site, , operating principles,
conditions of use are substantially equivalent to predicates.
The technological characteristics of the subject device and the
predicates are substantially equivalent to the predicates. |
| Performance
Analysis | Subject device has similar configuration, material, sizes and design
as the predicate devices. Mechanical performance and engineering
assessment with worst case of subject device and corresponding
predicate devices, confirm that subject devices have equivalent or
better strength and resistance.
Any potential hazard have been evaluated and controlled through
Risk Management activities.
The review of clinical literatures on similar devices still support the
clinical data of the Subject devices with no additional clinical
information.
Pyrogenicity testing was conducted in support of substantial
equivalence. |
| Conclusion | Based upon equivalences in: intended use, site of application, ,
conditions of use, performance data, operating principles, and
according to the results of nonclinical testing, the subject devices
belonging to RIVAL™ VIEW Plating System™ and REDUCE
Fracture Plating System™ have been shown to be safe, as effective,
and performs as well as or better than the legally marketed predicate
device.
Therefore, the Subject device is expected to be substantially
equivalent to the legally marketed predicate devices. |
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