(28 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI or ML.
Yes
The device is intended for the treatment, fixation, and correction of various medical conditions, including fractures, contractures, deformities, and for limb lengthening, all of which are considered therapeutic applications.
No
The device is an external fixation system used for the treatment and fixation of various orthopedic conditions, not for diagnosing them.
No
The device description explicitly lists hardware components such as wires, pins, struts, rods, bolts, fasteners, clamps, and plates, which are part of an external fixation system. This indicates it is a physical medical device, not software-only.
Based on the provided information, the Monkey Rings™ External 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 for diagnosis, monitoring, or screening.
- Monkey Rings™ Function: The description clearly states that the Monkey Rings™ External Fixation System is a modular, ring-based, external fixation system designed for the treatment and fixation of various musculoskeletal conditions. It is a physical device applied externally to the body to stabilize bones and correct deformities.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is purely mechanical and structural.
Therefore, the Monkey Rings™ External Fixation System falls under the category of a medical device used for surgical and orthopedic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Monkey Rings™ External 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 Monkey Rings™ External 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 (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Monkey Rings™ External 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 Monkey Rings™ External 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 Monkey Rings™ External 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, 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)
An engineering analysis of bending strength was conducted to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. For biocompatibility, both materials are identical to materials cleared in Paragon 28 External Ring Fixation System (K212895) and differences in manufacturing methods do not impact biocompatibility endpoints. Sterilization parameters have been validated to accomplish a sterility assurance level (SAL) of 10t and the methods used to establish the sterility are identical to the methods used to establish the sterility of the Paragon 28 External Ring Fixation System in K212895.
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 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.
0
Image /page/0/Picture/0 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.
October 12, 2023
Paragon 28, Inc. Edward Wells-Spicer Regulatory Affairs Specialist 14445 Grasslands Drive Englewood, Colorado 80112
Re: K232838
Trade/Device Name: Monkey Rings™ 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: September 13, 2023 Received: September 14, 2023
Dear Edward Wells-Spicer:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Lixin Liu -S
Lixin Liu. Ph.D 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Monkey Rings™ External Fixation System
Indications for Use (Describe)
The Monkey Rings™ External 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 Monkey Rings™ External 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)
( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 1
510(k) Summary
| Device Trade Name: | Monkey Rings™ External Fixation System |
|---|---|
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr., | |
| Englewood, CO 80112 | |
| Contact: | Edward Wells-Spicer |
| Regulatory Affairs Specialist | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| ewspicer@paragon28.com | |
| Date Prepared: | October 12, 2023 |
| Classifications: | 21 CFR §888.3030 |
| Class: | II |
| Product Codes: | KTT |
Indications for Use:
The Monkey Rings™ External 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 Monkey Rings™ External 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 Monkey Rings™ External 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 Monkey Rings™ External 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 Monkey Rings™ External 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.
Predicate Device:
| Table 1: Predicate Device | ||||
|---|---|---|---|---|
| Device Name(s) | Manufacturer | K-Number | ||
| Paragon 28 External Ring Fixation System | Paragon 28, Inc. | K212895 |
Reference Device:
| Device Name(s) | Manufacturer | K-Number |
|---|---|---|
| Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation | Smith & Nephew | K201253 |
Non-Clinical Performance Testing Summary:
An engineering analysis of bending strength was conducted to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. For biocompatibility, both materials are identical to materials cleared in Paragon 28 External Ring Fixation System (K212895) and differences in manufacturing methods do not impact biocompatibility endpoints. Sterilization parameters have been validated to accomplish a sterility assurance level (SAL) of 10t and the methods used to establish the sterility are identical to the methods used to establish the sterility of the Paragon 28 External Ring Fixation System in K212895.
Substantial Equivalence Discussion:
The subject device is similar to the predicate device for technological characteristics. The differences between the subject device and predicate are the addition of longer wires, new titanium alloy wires and updated sterilization parameters. Indications are identical between the subject device and predicate. 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.
5
Page 3
Conclusion:
The performance data demonstrate that the subject device performs substantially equivalent to the predicate devices that are currently marketed for the same intended use. The Monkey Rings™ External 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.