(40 days)
Not Found
No
The document describes a standard bone plating system and does not mention any AI or ML components or functionalities.
No.
The device is an implantable metallic bone plate system used for the fixation of fractures or osteotomies, revision procedures, and joint fusion, which are structural interventions rather than therapeutic treatments in themselves.
No
The device description and intended use indicate it is an implantable plating system for fixation of fractures and bone reconstruction, not for diagnosing medical conditions.
No
The device description explicitly states it is a set of implantable metallic bone plates, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The Volition Plating System is described as a set of implantable metallic bone plates used for the fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones.
- Intended Use: The intended use clearly states the device is for surgical procedures involving bone repair and reconstruction.
The device is a surgical implant, not a device used to test biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Volition Plating System is indication and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.
In addition, the non-locking screws and washers are in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The Volition Plating System is a set of implantable metallic (Titanium Alloy) bone plates consisting of a series of tubular plates of varying lengths as well as anatomically contoured plates. The Volition Plating System plates are provided with locking and non-locking in Ø2.7mm, Ø3.5mm, & Ø4.0mm previously cleared under K202764. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis of the subject device was employed to demonstrate the Volition System bone plates are substantially equivalent to the predicate(s) with respect to bending strength performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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April 13, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Ortho Solutions UK Ltd Andy Leither US Technical and Development Director West Station Business Park, Spital Road Maldon, CMF 6FF GBR
Re: K210658
Trade/Device Name: Volition Plating 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, HWC, HTN Dated: March 4. 2021 Received: March 4, 2021
Dear Andy Leither:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (08) 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 mediation-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 -S
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Volition Plating System
Indications for Use (Describe)
The Volition Plating System is indication and fixation of fractures or osteotomies, revision procedures, joint fusion, and reconstruction of small bones of the feet and ankles, including the toes, talus, and calcaneus; the distal fibula and tibia; as well as the fingers, hands, and wrists.
In addition, the non-locking screws and washers are in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
| Type of Use (Select one or both, as applicable) | For Direct Use/Application (i.e. consumption of water) For Re-Circulation/Re-Use (i.e. cooling water) | For Direct Use/Application (i.e. consumption of water) | For Re-Circulation/Re-Use (i.e. cooling water) |
|---|---|---|---|
| For Direct Use/Application (i.e. consumption of water) | |||
| For Re-Circulation/Re-Use (i.e. cooling water) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for OrthoS. The word "OrthoSolutions" is written in red font. Below the word "OrthoSolutions" is the word "Group" in a smaller, gray font. To the right of the text is a gray and red symbol that looks like the letter S.
K210658 - 510(k) SUMMARY
Submitter Information
| Submitters Name:
Address: | Ortho Solutions UK Ltd
West Station Business Park
Spital Road
Essex, CM9 6FF
United Kingdom |
|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Fax Number:
Prepared By:
Contact Person:
Date Prepared: | +44 1621 843 599
+44 1621 858 953
Andy Leither
Andy Leither
09/16/2020 |
| Device Information | |
| Trade Name: | Volition Plating System |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone
Washer, Bolt Nut |
| Device Classification: | Class II per 21 CFR 888.3030 (Primary)
Single/multiple component metallic bone fixation appliances and
accessories.
Panel: Orthopedic |
| | Class II per 21 CFR 888.3040
Smooth or threaded metallic bone fixation fastener.
Panel: Orthopedic |
| | Class II per 21 CFR 888.3030
Single/multiple component metallic bone fixation appliances and
accessories.
Panel: Orthopedic |
| Product Code: | HRS (Primary)
HWC
HTN |
| Material Composition: | Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 |
| Device Description: | The Volition Plating System is a set of implantable metallic (Titanium
Alloy) bone plates consisting of a series of tubular plates of varying
lengths as well as anatomically contoured plates. The Volition Plating
System plates are provided with locking and non-locking in Ø2.7mm,
Ø3.5mm, & Ø4.0mm previously cleared under K202764. All implants
are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are
provided non-sterile. |
| Primary Predicate Device: | Ortho Solutions Plating System, K202764 |
| Additional Predicate Devices: | Ortho Solutions Trauma Plates for Osteosynthesis, K120360 |
| Indications for Use: | The Ortho Solutions Plating System is indicated for use in stabilization and
fixation of fractures or osteotomies, revision procedures, joint fusion, and
reconstruction of small bones of the feet and ankles, including the toes,
talus, and calcaneus; the distal fibula and tibia; as well as the fingers,
hands, and wrists. |
| | In addition, the non-locking screws and washers are indicated for use in
bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair,
and fracture fixation, appropriate for the size of the device. |
| Technological Characteristics: | The Volition Plating System is substantially equivalent in material,
geometry, design, and indications to the predicate devices. |
| Performance Analysis: | Engineering analysis of the subject device was employed to
demonstrate the Volition System bone plates are substantially
equivalent to the predicate(s) with respect to bending strength
performance. |
| Conclusion: | The Volition Plating System has been compared to the previously
cleared predicate devices with respect to indications for use, materials,
mechanical performance, and technological characteristics. The design
characteristics of the subject device do not raise new types of questions
regarding safety or efficacy. These comparisons demonstrate that the
Volition Plating System is substantially equivalence to the predicate
devices. |
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Image /page/4/Picture/0 description: The image shows the logo for OrthoSolutions Group. The words "OrthoSolutions" are in red, with the word "Group" in gray underneath. To the right of the text is a stylized silver and red symbol that resembles the letter S.