(90 days)
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing related to AI/ML.
No
Explanation: The device is an implant for internal bone fixation and not a therapeutic device. "Therapeutic device" implies a device delivers therapy, which this device does not. It provides structural support for bone growth and fusion.
No
The device is an implantable system designed for internal bone fractures or osteotomies in the foot, providing structural support and promoting bone growth and fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of "three implant designs" made from "Ti6Al4V alloy," which are physical 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Osteotomy Truss System (OTS) is a surgical implant intended for internal bone fixation during osteotomies (bone cuts) and fracture repair in the foot. It is a physical device implanted into the body to provide structural support.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes. Its function is purely mechanical and structural within the body.
Therefore, the Osteotomy Truss System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:
- Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Metatarsal/Cuneiform osteotomies
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
- Hindfoot osteotomies
The device is intended for use with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Osteotomy Truss System (OTS) consists of three implant designs in a variety of footprints and opening wedge height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixations.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot
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)
Validated finite element analysis demonstrated that the product line extension for the Osteotomy Truss System (OTS) does not introduce a new worst-case compared to the previously cleared 4WEB Osteotomy Truss System devices for mechanical properties of the device.
Performance testing has been completed per the following standards for the combined Osteotomy Truss System (OTS):
- Static axial compression per ASTM F2077
- Dynamic axial compression fatigue per ASTM F2077
- Expulsion testing per ASTM F-04.25.02.02
- MR image artifact per ASTM F2119
- MR induced heating per ASTM F2182
- MR induced torque per ASTM F2213
- MR induced displacement force per ASTM F2052
The results of this non-clinical testing show that the strength of the OTS Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Clinical testing was not necessary for the determination of substantial equivalence.
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.
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
May 18, 2022
Image /page/0/Picture/1 description: The image shows 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.
4WEB Medical, Inc. % Richard Jansen President Silver Pine Consulting 3851 Mossy Oak Drive Fort Myers, Florida 33905
Re: K220463
Trade/Device Name: Osteotomy Truss System (OTS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: January 3, 2022 Received: February 17, 2022
Dear Richard Jansen:
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,
Shumaya Ali, MPH 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
Enclosure
2
Indications for Use
510(k) Number (if known) K220463
Device Name Osteotomy Truss System (OTS)
Indications for Use (Describe)
The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Metatarsal/Cuneiform osteotomies
- · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
- · Hindfoot osteotomies
The device is intended for use with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.
Type of Use (Select one or both, as applicable)
X 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
K220463 510(k) Summary
| Date Prepared: | February 16, 2022 |
|---|---|
| Contact: | Jessee Hunt, President |
| 4WEB, Inc. | |
| 2801 Network Blvd., Suite 620 | |
| Frisco, TX 75034 | |
| Phone: (800) 285-7090 | |
| Fax: 972-488-1816 | |
| Regulatory Contact: | Rich Jansen, Pharm. D. |
| Silver Pine Consulting, LLC | |
| richj@s-pineconsulting.com | |
| Trade Name: | Osteotomy Truss System (OTS) |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3030 |
| Common Name: | Single/Multiple Component Metallic Bone Fixation Appliances and |
| Accessories | |
| Product Codes: | HRS |
| Panel Code: | 87 |
Purpose:
The purpose of this submission is to update the design of the Osteotomy Truss System (OTS) implants and instruments and to provide the OTS implants as sterile packaged.
Indications for Use:
The Osteotomy Truss System (OTS) is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- Metatarsal/Cuneiform osteotomies
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
- Hindfoot osteotomies
The device is intended for use with supplemental fixation.
The Osteotomy Truss System is not intended for use in the spine.
4
Device Description:
The Osteotomy Truss System (OTS) consists of three implant designs in a variety of footprints and opening wedge height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixations.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.
Predicate Device(s):
The primary predicate device is the 4WEB Medical Osteotomy Truss System (K172294). Other predicate device: 4WEB Medical Osteotomy Bone Wedge (K130185) Reference Device: 4WEB Medical Lateral Spine Truss System (K211388)
Non-Clinical Performance Testing Standards:
Validated finite element analysis demonstrated that the product line extension for the Osteotomy Truss System (OTS) does not introduce a new worst-case compared to the previously cleared 4WEB Osteotomy Truss System devices for mechanical properties of the device.
Performance testing has been completed per the following standards for the combined Osteotomy Truss System (OTS):
- Static axial compression per ASTM F2077
- Dynamic axial compression fatigue per ASTM F2077
- Expulsion testing per ASTM F-04.25.02.02
- MR image artifact per ASTM F2119
- MR induced heating per ASTM F2182
- MR induced torque per ASTM F2213
- MR induced displacement force per ASTM F2052
The results of this non-clinical testing show that the strength of the OTS Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Clinical Performance Testing:
Clinical testing was not necessary for the determination of substantial equivalence.
Comparison of Technological Characteristics:
4WEB, Inc. has compared these devices to the previously cleared predicate devices in regard to indications for use, materials, function, sizes and simulated testing. The subject device implants introduce design modifications such as addition of a central hole, addition of an insertion feature, and a dorsal face modification. The subject device will also be provided in sterile packaging. The 4WEB OTS devices included in this submission are composed of the same materials, have the same manufacturing process, same intended use, and are intended to be inserted using the same surgical procedure as the primary predicate device. These comparisons and performance testing demonstrate substantial equivalence to the predicate devices.
Conclusion:
4WEB, Inc. concludes that the OTS device is substantially equivalent to the predicate devices and raise no new questions of safety or effectiveness.