(254 days)
No
The device description and performance studies focus on mechanical properties and structural components, with no mention of AI or ML.
Yes
The device is used for stabilization and fixation of fractures, arthrodesis, and treatment of non-unions and mal-unions, which are all therapeutic interventions for orthopedic conditions.
No
The device, an external fixation system, is used for stabilization and fixation of fractures and for orthopedic surgery. It is a treatment device, not a diagnostic one as it does not gather or interpret data to identify a medical condition.
No
The device description explicitly states it is an "external fixation device consisting of bone pins, connecting rods, clamps, posts, and related accessories," 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The ONX Large External Fixation System is described as an "external fixation device consisting of bone pins, connecting rods, clamps, posts, and related accessories used for the management of bone fractures and reconstructive orthopedic surgery."
- Intended Use: The intended use is for the "Stabilization/fixation of... Long bone fractures... Fractures of pelvis and ankle... Peri-articular and intra-articular fractures... Joint arthrodesis... Non-unions and mal-unions... Osteotomies."
This device is clearly used externally on the body to stabilize bones and joints, not to analyze samples taken from the body. It is a surgical/orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
- Stabilization/fixation of:
- Long bone fractures in tibia and femur
- Fractures of pelvis and ankle
- Peri-articular and intra-articular fractures of knee and ankle
- Joint arthrodesis
- Non-unions and mal-unions
- Osteotomies
Product codes
KTT
Device Description
The ONX Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts, and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins, components, and posts are made from materials conforming to ASTM F136 and ASTM F138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis and lower extremities (tibia, femur, knee, ankle)
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
An engineering analysis has been conducted to evaluate the ONX Large External Fixation System according to ASTM F1541 and construct fatigue testing under axial load per ASTM F1541 Annex 7 has been performed to show that the subject is substantially equivalent to the predicate in mechanical performance.
Key Metrics
Not Found
Predicate Device(s)
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
August 25, 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.
OrthoNovis, Inc. Ken West CEO & President 1 Hargrove Grade, 2F Palm Coast, Florida 32137
Re: K213905
Trade/Device Name: ONX Large 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 Dated: July 29, 2022 Received: August 1, 2022
Dear Ken West:
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,
For:
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213905
Device Name ONX Large External Fixation System
Indications for Use (Describe)
- Stabilization/fixation of: ●
- o Long bone fractures in tibia and femur
- Fractures of pelvis and ankle о
- Peri-articular and intra-articular fractures of knee and ankle O
- Joint arthrodesis .
- Non-unions and mal-unions
- Osteotomies .
Type of Use (Select one or both, as applicable) 冈 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 801 Subpart C)
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3
| Submitter's Name: | OrthoNovis, Inc. |
|---|---|
| Submitter's Address: | 1 Hargrove Grade, 2F |
| Palm Coast, Florida 32137 | |
| Submitter's Telephone: | 352-807-3306 |
| Contact Person: | Ken West |
| Orthonovis, Inc. | |
| 352-807-3306 | |
| operations@orthonovis.com | |
| Date Summary was Prepared: | December 13, 2021 |
| Trade or Proprietary Name: | ONX Large External Fixation System |
| Common or Usual Name: | Large External Fixation System |
| Classification: | Class II per 21 CFR §888.3030 |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories |
| Product Code: | KTT |
| Classification Panel: | Orthopedic - Joint Arthroplasty Devices (DHT6A) |
K213905 - 510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The ONX Large External Fixation System is an external fixation device consisting of bone pins, connecting rods, clamps, posts, and related accessories used for the management of bone fractures and reconstructive orthopedic surgery. The device is a modular system designed to provide a broad range of frame construction options. The connecting rods are made from unidirectional carbon fiber reinforced epoxy. Pins, components, and posts are made from materials conforming to ASTM F136 and ASTM F138.
INDICATIONS FOR USE
The ONX Large External Fixation System is indicated for the following:
- Stabilization/fixation of: ●
- 0 Long bone fractures in tibia and femur
- Fractures of pelvis and ankle o
- o Peri-articular and intra-articular fractures of knee and ankle
- Joint arthrodesis
- Non-unions and mal-unions ●
- Osteotomies
TECHNOLOGICAL CHARACTERISTICS
The intended use, design principles, materials and overall dimensions of the subject and predicate devices are substantially the same. Both the subject and predicate devices are intended to stabilize traumatic or surgically created instabilities of the pelvis and lower extremities through the use of implantable pins and external components in a variety of sizes. These components are used to create a rigid construct (frame) suitable to the individual needs of the patient. As with one or more of the predicate devices, the implantable bone pins are made from titanium alloy or stainless steel and are distally threaded to enable unilateral or bilateral frame construction.
4
Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.
Data is provided to demonstrate substantial equivalence including engineering analysis of the subject and predicate designs.
Overall, ONX Large External Fixation System has the following similarities to the predicate devices:
- Has the same intended use,
- Uses the same operating principle, ●
- Incorporates the same design,
- Incorporates the same or very similar materials, and ●
- Has similar packaging and sterilized using the same materials and processes.
Table 5-1 Predicate Devices
| 510k
Number | Trade or Proprietary or
Model Name | Manufacturer | Product
Code | Predicate
Type |
|----------------|-------------------------------------------------|------------------------------------|-----------------|-------------------|
| K110965 | Renovis T 710 Large
External Fixation System | Renovis Surgical Technologies, LLC | KTT | Primary |
PERFORMANCE DATA
An engineering analysis has been conducted to evaluate the ONX Large External Fixation System according to ASTM F1541 and construct fatigue testing under axial load per ASTM F1541 Annex 7 has been performed to show that the subject is substantially equivalent to the predicate in mechanical performance.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the ONX Large External Fixation System is substantially equivalent to the predicate device.