(60 days)
Not Found
No
The summary describes a mechanical external fixation system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for "temporary stabilization of the long bones, feet, and pelvis" due to "fracture fixation" or "bony or soft tissue deformities," which are conditions that require medical treatment and healing assistance, thus classifying it as a therapeutic device.
No
The device is an external fixation system used for temporary stabilization of bones, not for diagnosing conditions. Its intended use is for fracture fixation and correcting deformities.
No
The device description explicitly states it consists of physical components like stainless steel bone pins, composite bars, and titanium clamps, which are hardware.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The MAVERICK External Fixation System is a physical device used to stabilize bones within the body (in vivo). It is used for fracture fixation and correcting deformities, which are surgical procedures performed directly on the patient.
The description clearly indicates a device used for surgical intervention and stabilization of bones, not for testing biological samples.
N/A
Intended Use / Indications for Use
The MAVERICK External Fixation System is intended to be used for temporary stabilization of the long bones, feet, and pelvis.
The indications for the Smith & Nephew MAVERICK 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 External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones, feet, pelvis
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)
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 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 Pin Testing: Axial Grip Strength of Clamps, Torsional Grip Strength of Clamps, Pin Insertion Force, Pin Pullout
Subject Clamps Testing: Torsional Grip Strength of Pins, Resistance to Slip at Internal Swivel Junction, Axial Grip Strength of Bars, Torsional Grip Strength of Bars, Axial Grip Strength with Pins
Subject Clamps/Post Testing: Axial Grip Strength of Clamps, Torsional Grip Strength of Clamps
Testing of Interconnections in Full Constructs: Cyclic Testing of Pelvic Frames, Cyclic Testing of Joint Spanning Style Frames
Rigidity Testing to Failure of Full Constructs: Load to Failure of Pelvic Frames, Load to Failure of Joint Spanning Style Frames
A 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
February 11, 2022
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 logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew, Inc. Brad Sheals Senior Regulatory Affairs Manager 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K213874
Trade/Device Name: MAVERICK 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: December 10, 2021 Received: December 13, 2021
Dear Brad Sheals:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 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,
Ting Song, Ph.D., R.A.C. 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
2
Indications for Use
510(k) Number (if known)
Device Name MAVERICK External Fixation System
Indications for Use (Describe)
The MAVERICK External Fixation System is intended to be used for temporary stabilization of the long bones, feet, and pelvis.
The indications for the Smith & Nephew MAVERICK 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
-We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | December 10, 2021 |
| | Mr. Brad Sheals, MS
Senior Regulatory Affairs Manager
T 901-288-7141
F 901-566-7911 |
| Name of Device: | MAVERICK 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. | Jet-X Bar System Clamps,
Bars and Posts – MR Safe
(Primary Predicate) | K072212 | March 7, 2008 |
| Austin Miller
Trauma LLC | Austin Miller Large External
Fixation System | K181528 | February 28,
2019 |
| 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 External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.
4
Indications for Use
The MAVERICK External Fixation System is intended to be used for temporary stabilization of the long bones, feet, and pelvis.
The indications for the Smith & Nephew MAVERICK 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 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 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 Pin Testing | Axial Grip Strength of Clamps |
| Torsional Grip Strength of Clamps | |
| Pin Insertion Force | |
| Pin Pullout | |
| Subject Clamps Testing | Torsional Grip Strength of Pins |
| Resistance to Slip at Internal | |
| Swivel | |
| Junction | |
| Axial Grip Strength of Bars | |
| Torsional Grip Strength of Bars | |
| Axial Grip Strength with Pins | |
| Subject Clamps/Post Testing | Axial Grip Strength of Clamps |
| Torsional Grip Strength of Clamps | |
| Testing of Interconnections in Full Constructs | Cyclic Testing of Pelvic Frames |
| Cyclic Testing of Joint Spanning Style | |
| Frames | |
| Rigidity Testing to Failure of Full Constructs | Load to Failure of Pelvic Frames |
| Load to Failure of Joint Spanning Style | |
| Frames |
Overall Bench Performance Testing Strategy
A 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 External Fixation System is substantially equivalent to the commercially available predicate devices.