(59 days)
No
The description focuses on the mechanical components and modular design of an external fixation system, with no mention of AI or ML for analysis, planning, or control.
Yes.
The device is used for the "treatment and fixation" of various conditions, including fractures, contractures, pseudoarthrosis, and for limb lengthening and correction of bony or soft tissue deformity, which are all therapeutic interventions.
No
The device is an external ring fixation system used for treatment and fixation of various conditions, not for diagnosing them.
No
The device description explicitly details physical components such as rings, wires, pins, struts, rods, bolts, fasteners, clamps, and plates, indicating it is a hardware-based external fixation system.
Based on the provided information, the Paragon 28 External Ring Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Paragon 28 External Ring Fixation System clearly indicate that it is a surgical device used externally on the body to fixate and correct bones. It does not involve the analysis of specimens taken from the body.
Therefore, the Paragon 28 External Ring Fixation System falls under the category of a surgical or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Paragon 28 External Ring Fixation System is indicated in pediatric patients and adults for the treatment and fixation of:
- Open and closed fractures
- Post-traumatic joint contracture which has resulted in loss of range of motion ●
- Fractures and disease which generally may result in joint contractures or loss of ● range of motion and fractures requiring distraction
- Pseudoarthrosis, infected union, non-union, or malunion of long bones ●
- Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction ●
- Correction of bony or soft tissue deformity (e.g. orthoplastic surgery) ●
- Correction of segmental bony or soft tissue defects
- Joint arthrodesis
- Management of comminuted intra-articular fractures ●
- Bone transport
The Paragon 28 External Ring Fixation System is indicated in adults for:
- Osteotomy
- Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures ●
- Fusions and replantations of the foot ●
- Charcot foot reconstruction
- Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle ●
- Lisfranc dislocations ●
- Ankle distraction (arthrodiastasis)
- Septic fusion ●
Product codes
KTT
Device Description
The Paragon 28 External Ring Fixation System is a modular, ring-based, external fixation system designed for the treatment and fixation of a variety of conditions in pediatric and adult patients. The Paragon 28 External Ring Fixation System utilizes wires, pins, struts, rods, bolts, fasteners, clamps, and plates that connect to rings statically placed or gradually manipulated in order to fixate or correct the bone. The modular design of the system allows for a customized treatment for the patient.
Components of the Paragon 28 External Ring Fixation System may be used in conjunction with all Paragon 28 legally marketed devices.
The components of the device are offered in a variety of sizes, which allow for a truly customized external fixation device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric patients and adults
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 on the components and full Paragon 28 External Ring Fixation System has been performed in accordance with ASTM F1541.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
November 8, 2021
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Paragon 28, Inc Haylie Hertz Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112
Re: K212895
Trade/Device Name: Paragon 28 External Ring 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: September 9, 2021 Received: September 10, 2021
Dear Haylie Hertz:
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
80 and Part 809); 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 Arthroplaty 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)
K212895
Device Name Paragon 28 External Ring Fixation System
Indications for Use (Describe)
The Paragon 28 External Ring Fixation System is indicated in pediatric patients and adults for the treatment and fixation of:
- Open and closed fractures
- Post-traumatic joint contracture which has resulted in loss of range of motion
· Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- · Pseudoarthrosis, infected union, non-union, or malunion of long bones
- Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
- · Correction of bony or soft tissue deformity (e.g. orthoplastic surgery)
- · Correction of segmental bony or soft tissue defects
- · Joint arthrodesis
- · Management of comminuted intra-articular fractures
- · Bone transport
The Paragon 28 External Ring Fixation System is indicated in adults for:
- Osteotomy
- Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures
- · Fusions and replantations of the foot
- Charcot foot reconstruction
- · Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
- · Lisfranc dislocations
- · Ankle distraction (arthrodiastasis)
- · Septic fusion
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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3
7 510(k) Summary
| Device Trade Name: | Paragon 28 External Ring Fixation System |
|---|---|
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr., | |
| Englewood, CO 80112 | |
| Contact: | Ms. Haylie Hertz |
| Regulatory Affairs Specialist | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| hhertz@paragon28.com | |
| Date Prepared: | September 9, 2021 |
| Classifications: | 21 CFR §888.3030 |
| Class: | II |
| Product Codes: | KTT |
Indications for Use:
The Paragon 28 External Ring Fixation System is indicated in pediatric patients and adults for the treatment and fixation of:
- Open and closed fractures
- Post-traumatic joint contracture which has resulted in loss of range of motion ●
- Fractures and disease which generally may result in joint contractures or loss of ● range of motion and fractures requiring distraction
- Pseudoarthrosis, infected union, non-union, or malunion of long bones ●
- Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction ●
- Correction of bony or soft tissue deformity (e.g. orthoplastic surgery) ●
- Correction of segmental bony or soft tissue defects
- Joint arthrodesis
- Management of comminuted intra-articular fractures ●
- Bone transport
The Paragon 28 External Ring Fixation System is indicated in adults for:
- Osteotomy
- Revision procedure where other treatments or devices have been unsuccessful
- Bone reconstruction procedures ●
- Fusions and replantations of the foot ●
- Charcot foot reconstruction
- Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle ●
4
- Lisfranc dislocations ●
- Ankle distraction (arthrodiastasis)
- Septic fusion ●
Device Description:
The Paragon 28 External Ring Fixation System is a modular, ring-based, external fixation system designed for the treatment and fixation of a variety of conditions in pediatric and adult patients. The Paragon 28 External Ring Fixation System utilizes wires, pins, struts, rods, bolts, fasteners, clamps, and plates that connect to rings statically placed or gradually manipulated in order to fixate or correct the bone. The modular design of the system allows for a customized treatment for the patient.
Components of the Paragon 28 External Ring Fixation System may be used in conjunction with all Paragon 28 legally marketed devices.
The components of the device are offered in a variety of sizes, which allow for a truly customized external fixation device.
Primary Predicate Device:
| Table 2: Primary Predicate Devices | ||
|---|---|---|
| Device Name(s) | Manufacturer | K-Number |
| Hoffmann LRF System | Stryker | K203568 |
Reference Predicate Device:
Table 3: Reference
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|---|---|---|---|---|
| Table 3: Reference Predicate Devices | ||||
| Device Name(s) | Manufacturer | K-Number | ||
| RingFIX System | Small Bone Innovations (SBi) | K071394 | ||
| MAXFRAME Multi-Axial Correction System DePuy Synthes | K161417 |
Performance Testing Summary:
Non-clinical testing on the components and full Paragon 28 External Ring Fixation System has been performed in accordance with ASTM F1541.
Comparison of Technological Characteristics:
In support of the claim of substantial equivalence the comparison between the subject and predicate system demonstrates a shared use of material, fundamental design, and general operating principles.
Conclusion:
The Paragon 28 External Ring Fixation System was demonstrated to be substantially equivalent to the predicate cited in the passage above with respect to indications, design, materials, function, manufacturing, and performance.