(206 days)
Not Found
No
The document describes a passive titanium implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
This device is an implant used for internal bone fractures and osteotomies and is not described as providing any therapeutic effect like treatment or rehabilitation.
No
The device description indicates it is a titanium alloy implant for internal bone fractures or osteotomies, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "titanium alloy implant" and details its material and architecture, indicating it is a physical hardware device.
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: The Osteotomy Truss System is a titanium alloy implant intended for surgical use to fix bone fractures or osteotomies. It is a physical device implanted into the body.
- Intended Use: The intended use describes the surgical procedures the implant is used for, not diagnostic testing of biological samples.
The information clearly describes a surgical implant, not a diagnostic test performed outside the body.
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 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
These devices are intended to be used 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 is a titanium alloy implant used for correction of small bones in the foot. It is offered in three footprints and multiple sizes for each footprint with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4WEB truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the foot, Midfoot, Hindfoot
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)
Non-clinical testing:
ASTM F2077 – Static and dynamic axial compression
ASTM F2119 - MR Image Artifact
ASTM F2052 – MR Induced Displacement Force
ASTM F2213 – MR Induced Torque
ASTM F2182 - MR Induces Heating
Expulsion testing
The results indicate that the Osteotomy Truss System is substantially equivalent to the predicate device and is adequate for the intended use.
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
§ 888.3030 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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 22, 2018
4Web, Inc. % Rich Jansen Consultant Silver Pine Consulting, LLC. 1142 26 1/2 Ave Cumberland, Wisconsin 54829
Re: K172294
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 10, 2018 Received: January 12, 2018
Dear Rich 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172294
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 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
These devices are intended to be used 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)
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510(k) Summary
| Date Prepared: | February 16, 2018 |
|---|---|
| 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 Single/multiple component metallic bone |
| fixation appliances and accessories | |
| Common Name: | Bone Wedge |
| Product Codes: | HRS |
| Panel Code: | 87 |
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
These devices are intended to be used with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.
Device Description:
The Osteotomy Truss System is a titanium alloy implant used for correction of small bones in the foot. It is offered in three footprints and multiple sizes for each footprint with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4WEB truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.
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Predicate Device(s):
The Osteotomy Truss System is substantially equivalent to the primary predicate, which is the previously cleared 4WEB Osteotomy Bone Wedge (K130185). An additional predicate device is K152062, BIOFOAM Bone Wedge.
Non-clinical testing:
ASTM F2077 – Static and dynamic axial compression ASTM F2119 - MR Image Artifact ASTM F2052 – MR Induced Displacement Force ASTM F2213 – MR Induced Torque ASTM F2182 - MR Induces Heating Expulsion testing
The results indicate that the Osteotomy Truss System is substantially equivalent to the predicate device and is adequate for the intended use.
Technological Characteristics:
4WEB, Inc. has compared these changes to the previously cleared predicate devices in regards to indications for use, materials, function, sizes and mechanical test results. These comparisons demonstrate substantial equivalence to the predicate devices.
Conclusion:
4WEB, Inc. concludes that the OTS devices are substantially equivalent to the predicate devices.