(66 days)
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No
The summary describes a mechanical external fixation system with no mention of software, algorithms, or any AI/ML related terms. The performance studies are based on mechanical testing.
Yes
The device is described as an external fixation system used for temporary stabilization of long bones, feet, pelvis, and wrist, and for open and closed fracture fixation and bony or soft tissue deformities, which are all therapeutic interventions.
No
Explanation: The device is an external fixation system used for temporary stabilization of bones and for reconstructive/corrective orthopedic surgery. It is a therapeutic device, not a diagnostic one, as it does not identify or analyze a condition.
No
The device description explicitly states that the system consists of physical components such as stainless steel bone pins, composite and titanium bars, and titanium clamps, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary stabilization of the long bones, feet, pelvis, and wrist" and "Open and closed fracture fixation" and "Bony or soft tissue deformities." This describes a surgical device used directly on the patient's body for structural support and repair.
- Device Description: The device consists of "stainless steel bone pins, composite and titanium bars, and titanium clamps." These are physical components used to build an external frame.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the MAVERICK Mini External Fixation System does not involve any testing of biological samples.
Therefore, the MAVERICK Mini External Fixation System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Smith & Nephew's MAVERICK and MAVERICK Mini External Fixation System is intended to be used for temporary stabilization of the long bones, feet, pelvis, and wrist.
The indications for the Smith & Nephew MAVERICK Mini External Fixation System are the following:
- Open and closed fracture fixation
- Bony or soft tissue deformities
Product codes (comma separated list FDA assigned to the subject device)
KTT, JDW
Device Description
The subject of this premarket notification is the MAVERICK Mini External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet, wrist, and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite and titanium bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones, feet, pelvis, and wrist
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)
Mechanical testing and/or assessments were utilized. A review of the data indicates that the subject MAVERICK Mini External Fixation System is substantially equivalent to one or more of the previously cleared predicate devices listed above.
The following overall bench performance strategy was used as a basis for the determination of substantial equivalence:
- Subject Clamps Testing:
- Torsional Grip Strength with Pins
- Axial Grip Strength with Pins
- Resistance to Slip at Internal Swivel Junction
- Axial Grip Strength with Bars
- Torsional Grip Strength of Bars
- Rigidity Testing to Failure of Full Constructs:
- Load to Failure of Wrist Spanning Style Frames – double pin clamps
- Load to Failure of Wrist Spanning Style Frames - bar to pin clamps
- Mating to MAVERICK Large System:
- Large Clamp Grip on 6mm Bars
A Declaration of Conformity for biocompatibility assessment was completed. A MRI justification was utilized in lieu of testing.
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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December 8, 2022
Smith & Nephew, Inc. Allison Francis Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K223112
Trade/Device Name: MAVERICK Mini External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT. JDW Dated: September 30, 2022 Received: October 3, 2022
Dear Allison Francis:
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,
Ting Song -S
Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty 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)
Device Name MAVERICK Mini External Fixation System
Indications for Use (Describe)
Smith & Nephew's MAVERICK and MAVERICK Mini External Fixation System is intended to be used for temporary stabilization of the long bones, feet, pelvis, and wrist.
The indications for the Smith & Nephew MAVERICK Mini External Fixation System are the following:
-
- Open and closed fracture fixation
- Bony or soft tissue deformities
| 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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3
Smith Nephew
| Submitted by: | Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 |
|---|---|
| Date of Summary: | September 30, 2022 |
| Primary Contact: | |
| Ms. Allison Francis Regulatory Affairs Specialist T 901-572-5959 | |
| Secondary Contact: | |
| Mr. Brad Sheals, MS Senior Regulatory Affairs Manager T 901-288-7141 F 901-566-7911 | |
| Name of Device: | MAVERICK Mini External Fixation System |
| Common Name: | Multi-lateral Fixators and Accessories |
| Device Classification Name and Reference: | 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories |
| 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener | |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | KTT, JDW |
Predicates
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|----------------------------------------------------------|----------------------|----------------------|
| Smith & Nephew,
Inc. | MAVERICK External Fixation
System (Primary Predicate) | K213874 | February 11,
2022 |
| Smith & Nephew,
Inc. | Smith & Nephew External
Fixation System (Jet-X) | K994143 | February 18,
2000 |
Device Description
The subject of this premarket notification is the MAVERICK Mini External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet, wrist, and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite and titanium bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.
4
Smith Nephew
Indications for Use
Smith & Nephew's MAVERICK and MAVERICK Mini External Fixation System is intended to be used for temporary stabilization of the long bones, feet, pelvis, and wrist.
The indications for the Smith & Nephew MAVERICK Mini External Fixation System are the following:
- Open and closed fracture fixation .
- Bony or soft tissue deformities .
Technological Characteristics
The principle of operation for the subject and the predicate devices is stabilization of bones through fixation with pins clamped to an external fixation frame built with composite bars. The MAVERICK Mini External Fixation System is similar to legally marketed predicate devices in that they are manufactured from similar materials, are of structurally similar size, strength and stiffness, and incorporate similar methods of assembly and adjustment.
Performance Testing
To further support a determination of substantial equivalence, Mechanical testing and/or assessments were utilized. A review of the data indicates that the subject MAVERICK Mini External Fixation System is substantially equivalent to one or more of the previously cleared predicate devices listed above. The following overall bench performance strategy was used as a basis for the determination of substantial equivalence.
| Device Testing | |
|---|---|
| Subject Clamps Testing | Torsional Grip Strength with Pins |
| Axial Grip Strength with Pins | |
| Resistance to Slip at Internal Swivel | |
| Junction | |
| Axial Grip Strength with Bars | |
| Torsional Grip Strength of Bars | |
| Rigidity Testing to Failure of Full Constructs | Load to Failure of Wrist Spanning Style |
| Frames – double pin clamps | |
| Load to Failure of Wrist Spanning Style | |
| Frames - bar to pin clamps | |
| Mating to MAVERICK Large System | Large Clamp Grip on 6mm Bars |
Overall Bench Performance Testing Strategy
A Declaration of Conformity for biocompatibility assessment was completed. A MRI justification was utilized in lieu of testing.
Conclusion
Based on similarities to the predicate multi-lateral external fixation systems and a review of testing performed, the subject MAVERICK Mini External Fixation System is substantially equivalent to the commercially available predicate devices.