(60 days)
Not Found
No
The summary describes a traditional orthopedic plating system and does not mention any AI or ML components or functionalities.
Yes
The device is used for stabilization of fractures, osteotomies, joint fusion, and reconstruction, which are therapeutic interventions.
No
The device description clearly states "The Ortho Solutions Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths." Its intended use is for stabilization of fractures, reconstruction, and fixation, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly states it is a set of implantable metallic bone plates and screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Ortho Solutions Plating System is described as a set of implantable metallic bone plates and screws. These are physical implants used to stabilize fractures and perform surgical procedures directly on the body.
- Intended Use: The intended use clearly states stabilization of fractures, osteotomies, joint fusion, and reconstruction of bones. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant system, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Ortho Solutions Plating System is indicated for use in stabilization 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.
Product codes
HRS, HWC, HTN
Device Description
The Ortho Solutions Plating System is a set of implantable metallic (Titanium Alloy) bone plates, locking and non-locking screws of various lengths. The system consists of a series of tubular plates of varying lengths as well as anatomically contoured plates. Locking and non-locking screws are provided in Ø2.7mm, Ø3.5mm, & Ø4.0mm in various lengths and are compatible with all plates. All implants are made from Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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)
Performance testing per ASTM F382, engineering analysis and rationale was completed for the plates to demonstrate substantial equivalence for static and fatigue bending strength. Performance testing was completed for the screws per ASTM F543 to demonstrate substantial equivalence with respect to torsional strength, insertion torque, and pullout strength.
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.
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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2020
Ortho Solutions UK Ltd Andy Leither US Technical and Development Director West Station Business Park Spital Road Essex, CM9 6FF United Kingdom
Re: K202764
Trade/Device Name: Ortho Solutions 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: September 16, 2020 Received: September 21, 2020
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.
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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) 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 (OS) 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202764
Device Name Ortho Solutions Plating System
Indications for Use (Describe)
The Ortho Solutions Plating System is indicated for use in stabilization 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.
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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Image /page/3/Picture/0 description: The image contains 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 "S" symbol, which is also in red and gray.
K202764 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:
Device Information | +44 1621 843 599
+44 1621 858 953
Andy Leither
Andy Leither
09/16/2020 |
| | |
| Trade Name: | Ortho Solutions 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 Ortho Solutions Plating System is a set of implantable metallic
(Titanium Alloy) bone plates, locking and non-locking screws of various
lengths. The system consists of a series of tubular plates of varying
lengths as well as anatomically contoured plates. Locking and non-
locking screws are provided in Ø2.7mm, Ø3.5mm, & Ø4.0mm in various
lengths and are compatible with all plates. All implants are made from
Titanium Alloy (Ti-6AL-4V ELI) per ASTM F136 and are provided non-
sterile. |
| Primary Predicate Device: | Ortho Solutions Trauma Plates for Osteosynthesis, K120360 |
| Additional Predicate Devices: | Ortho Solutions UltOS Plating System, K141784 |
| | Wright Medical ORTHOLOC 3Di Ankle Fracture Plating System, K163044 |
| 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 Ortho Solutions Plating System is substantially equivalent in
material, geometry, design, and indications to the predicate devices. |
| Performance Analysis: | Performance testing per ASTM F382, engineering analysis and rationale
was completed for the plates to demonstrate substantial equivalence
for static and fatigue bending strength. Performance testing was
completed for the screws per ASTM F543 to demonstrate substantial
equivalence with respect to torsional strength, insertion torque, and
pullout strength. |
| Conclusion: | The Ortho Solutions 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 Ortho Solutions 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 appears to be an abstract letter S.