(85 days)
Not Found
No
The device description and performance studies focus on traditional orthopedic implants and mechanical testing, with no mention of AI/ML terms or functionalities.
Yes
The device is described as an orthopedic plate system used to stabilize and aid in the repair of fractures, fusions, and osteotomies, which is a therapeutic function.
No
The device is an orthopedic plate system used to stabilize and aid in the repair of fractures, fusions, and osteotomies; it does not collect or analyze data to diagnose a condition.
No
The device description explicitly states it consists of "various plates and screws" made from metal, which are physical 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The SkyOPS™ Orthopedic Plate System is described as a system of plates and screws made from metal, intended to be implanted in the body to stabilize fractures and aid in repair.
- Intended Use: The intended use is to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bones in the foot. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a surgical implant device, not a diagnostic device.
N/A
Intended Use / Indications for Use
The SkyOPS™ Orthopedic Plate System is indicated to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bone fragments of the foot. The system can be used in both adult and pediatric patients aged >12 years (adolescent, transitional adolescent B).
Product codes
HRS, HWC
Device Description
The subject SkyOPS™ Orthopedic Plate System consists of various plates and screws that are used to stabilize and aid in the fusion or repair of fractures or osteotomies of small bones. The plates are offered in different lengths and sizes. The screws are offered in one diameter with different lengths. All implantable metal components are made from Ti-6Al-4V ELI per ASTM F136 or ASTM F3001. The devices are provided non-sterile to be cleaned and steam sterilized by the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot
Indicated Patient Age Range
adult and pediatric patients aged >12 years (adolescent, transitional adolescent B)
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
Biocompatibility testing per ISO 10993-1 and performance testing per ASTM F534-17 (Annexes 1-3) and ASTM F384-17 (Annexes 1-2) was conducted on the subject devices and results demonstrated substantial equivalence to the predicates.
Key Metrics
Not Found
Predicate Device(s)
K121437, K170214, K010321, K221181
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
December 21, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Sky Surgical LLC % Danielle Besal Principal Consultant MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial, Colorado 80112
Re: K233154
Trade/Device Name: SkyOPSTM Orthopedic 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, HWC Dated: September 27, 2023 Received: September 27, 2023
Dear Danielle Besal:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, M.P.H. 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
2
Indications for Use
510(k) Number (if known) K233154
Device Name SkyOPSTM Orthopedic Plate System
Indications for Use (Describe)
The SkyOPS™ Orthopedic Plate System is indicated to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bone fragments of the foot. The system can be used in both adult and pediatric patients aged >12 years (adolescent, transitional adolescent B).
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K233154
510(k) Summary
SkyOPS™ Orthopedic Plate System December 21, 2023
| Company: | Sky Surgical
39 Nettleingham Rd
Sandpoint, ID 83864 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Danielle Besal
Principal Consultant MRC Global
901.827.8670
Danielle.Besal@askmrcglobal.com |
| Company Contact: | Jeff Sander
Chief Operating Officer Sky Surgical
480.266.8605
jsander@sky-surgical.com |
| Trade Name: | SkyOPS™ Orthopedic Plate System |
| Common Name: | Plate, Fixation, Bone; Screw, Fixation, Bone |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3030 (Primary) Single/multiple component metallic bone
fixation appliances and accessories; 21 CFR 888.3040 Smooth or
threaded metallic bone fixation fastener |
| Panel: | Orthopedic |
| Product Code: | HRS (Primary), HWC |
| Predicate Devices: | K121437 Mini MaxLock Extreme Plating System (Primary)
K170214 Additive Orthopaedics Locking Lattice Plate
K010321 Modular Foot System – 2.7mm Module
K221181 TMC Plating System |
Device Description:
The subject SkyOPS™ Orthopedic Plate System consists of various plates and screws that are used to stabilize and aid in the fusion or repair of fractures or osteotomies of small bones. The plates are offered in different lengths and sizes. The screws are offered in one diameter with different lengths. All implantable metal components are made from Ti-6Al-4V ELI per ASTM F136 or ASTM F3001. The devices are provided non-sterile to be cleaned and steam sterilized by the end user.
Indications for Use:
The SkyOPS™ Orthopedic Plate System is indicated to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bone fragments of the foot. The system can be used in both adult and pediatric patients aged > 12 years (adolescent, transitional adolescent B).
Substantial Equivalence:
The SkyOPS™ Orthopedic Plate System is substantially equivalent to the predicate devices (K121437, K170214, K010321, K221181). The subject and predicate devices are identical in intended use and materials and equivalent in technological characteristics. Testing has demonstrated that performance of
4
K233154
the subject devices is equivalent to that of the predicates and, thus, the differences in geometry and manufacturing versus the predicates do not raise different questions of safety and effectiveness.
Performance Testing:
Biocompatibility testing per ISO 10993-1 and performance testing per ASTM F534-17 (Annexes 1-3) and ASTM F384-17 (Annexes 1-2) was conducted on the subject devices and results demonstrated substantial equivalence to the predicates.
Conclusion:
The SkyOPS™ Orthopedic Plate System is considered substantially equivalent to the predicate devices (K121437, K170214, K010321, K221181).