(216 days)
Not Found
No
The device description focuses on mechanical components and their function in external fixation, with no mention of AI or ML. Performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is described as a system for stabilizing fractures and osteotomies, correcting bone deformities, arthrodesis, and limb lengthening, all of which are direct treatments for medical conditions.
No
The device description and intended use clearly state that the FusionFrame Ring Lock System is used for stabilization, correction, arthrodesis, and limb lengthening, which are all therapeutic interventions, not diagnostic functions.
No
The device description clearly outlines hardware components such as rings, pins, bolts, struts, and wrenches, and describes mechanical testing performed on these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on the musculoskeletal system (stabilization of fractures, bone deformity correction, arthrodesis, limb lengthening). This is a therapeutic and structural function, not a diagnostic one performed on in vitro samples.
- Device Description: The description details a system of rings, pins, struts, and other components designed to be externally applied to the body to provide support and manipulate bone. This is consistent with an external fixation device used in orthopedic surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the FusionFrame Ring Lock System is a surgical device, specifically an external fixation system, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FusionFrame Ring Lock System is indicated for:
- · Stabilization of fractures and osteotomies;
- · Bone deformity correction of lower extremities;
- · Arthrodesis of the rear foot, mid foot and ankle joint; and
- · Limb Lengthening in pediatric and adult patients.
Product codes
KTT
Device Description
This submission is a line extension to the FusionFrame™ Ring Lock System product line to include fixation pins, pin fixation bolts, pin fixation cubes, threaded sockets, conical washer couples, T-wrench and adapters, hinges, telescoping struts and 5/8 rings to improve the configuration options that the FusionFrame™ Ring Lock System can provide and to be competitively comparable to other circular external fixation predicate devices.
The FusionFrame™ Ring Lock System is an updated version of previously existing circular fixators that is specifically designed for the treatment of pathologies including:
- Stabilization of Fractures and Osteotomies. .
- Bone deformity corrections of lower extremities. .
- Arthrodesis of: .
- 0 Rear Foot
- 0 Mid Foot
- 0 Ankle Joint
- Adult and pediatric limb lengthening
The Fusion Frame was developed to specifically address the extensive requirements of orthopedic surgeons and foot and ankle specialists. Its components have been designed to ensure overall construct stability, versatility, ease of application, functionality and time saving efficiency. Briefly described, the FusionFrame™ provides a weight bearing scaffold that in most cases allows patients to remain mobile throughout the course of treatment.
The numerous variety of constructs afforded by the FusionFrame™ provides a systematic platform for ensuring stability, re-aligning bones, applying compressive forces or controlling the distraction of bone fragments over a period of time. The FusionFrame™ consists of externally mounted Rings and ancillary components that are interconnected with threaded rods and/or telescoping struts. The construct is attached to the bone with a combination of percutaneously applied tensioned Wires and/or Half-Pins. Telescoping struts with compression/distraction nuts may be attached to the frame to systematically control the gaps between bone fragments and distance between Rings to manage a variety of pathologies. Threaded rods or struts may be used to reduce and compress fracture zones, lengthen limbs and even correct deformities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower extremities, rear foot, mid foot, ankle joint.
Indicated Patient Age Range
Pediatric and adult patients.
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 laboratory testing was performed on the worst-case subject device to determine substantial equivalence. The following testing was performed with reference to ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices:
- Static Torsion Test and Cantilever bend test on Half pins
- Static Axial Compression Testing on Struts ●
Design Verification testing demonstrated that the subject device is substantially equivalent to the currently marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FUSION MEDICAL RING LOCK SYSTEM (K100857), SALVATION External Fixation System (K180832), ILIZAROV EXTERNAL FIXATION SYSTEM (K962808)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.
September 14, 2020
GLW Medical Innovation Elijah Wreh Regulatory Consultant 300 Sylvan Avenue Englewood Cliffs, New Jersey 07632
Re: K200343
Trade/Device Name: FusionFrame Ring Lock 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: August 5, 2020 Received: August 7, 2020
Dear Elijah Wreh:
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 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,
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
Indications for Use
510(k) Number (if known) K200343
Device Name
FusionFrame™ Ring Lock System
Indications for Use (Describe)
The FusionFrame Ring Lock System is indicated for:
- · Stabilization of fractures and osteotomies;
- · Bone deformity correction of lower extremities;
- · Arthrodesis of the rear foot, mid foot and ankle joint; and
- · Limb Lengthening in pediatric and adult patients.
| 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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3
510(k) Summary
Submitter Information per 21 CFR 807.92(a)(1)
| SPONSOR: | GLW Medical Innovation
300 Sylvan Ave
Englewood Cliffs, NJ 07632 |
|----------------------------------------|-----------------------------------------------------------------------------------------------|
| PRIMARY CONTACT: | Arundhati Radhakrishnan
Quality Assurance Manager |
| SECONDARY CONTACT: | Elijah & Elisha, LLC
Regulatory Consultant |
| MANUFACTURER: | GLW Medical Innovation
300 Sylvan Ave
Englewood Cliffs, NJ 07632
Tel: (877) 287-0795 |
| DATE PREPARED per 21 CFR 807.92(a)(1): | 13 September 2020 |
Device Information per 21 CFR 807.92(a)(2)
| NAME OF SUBJECT DEVICE: | FusionFrame™ Ring Lock System |
|---|---|
| COMMON/USUAL NAME: | External Fixator |
| CLASSIFICATION NAME: | Single/Multiple Component Metallic Bone Fixation |
| Appliances and Accessories (21 CFR 888.3030) | |
| REGULATORY CLASS: | 2 |
| PRODUCT CODE: | KTT - Single/Multiple Component Metallic Bone |
| Fixation Appliances and Accessories |
| PREDICATE DEVICES: | Primary Predicate: | |
|---|---|---|
| FUSION MEDICAL RING LOCK SYSTEM | ||
| (K100857) | ||
| Secondary Predicates: | ||
| SALVATION External Fixation System (K180832) | ||
| ILIZAROV EXTERNAL FIXATION SYSTEM | ||
| (K962808) |
4
Device Description per 21 CFR 808.92(a)(4)
This submission is a line extension to the FusionFrame™ Ring Lock System product line to include fixation pins, pin fixation bolts, pin fixation cubes, threaded sockets, conical washer couples, T-wrench and adapters, hinges, telescoping struts and 5/8 rings to improve the configuration options that the FusionFrame™ Ring Lock System can provide and to be competitively comparable to other circular external fixation predicate devices.
The FusionFrame™ Ring Lock System is an updated version of previously existing circular fixators that is specifically designed for the treatment of pathologies including:
- Stabilization of Fractures and Osteotomies. .
- Bone deformity corrections of lower extremities. .
- Arthrodesis of: .
- 0 Rear Foot
- 0 Mid Foot
- 0 Ankle Joint
- Adult and pediatric limb lengthening
The Fusion Frame was developed to specifically address the extensive requirements of orthopedic surgeons and foot and ankle specialists. Its components have been designed to ensure overall construct stability, versatility, ease of application, functionality and time saving efficiency. Briefly described, the FusionFrame™ provides a weight bearing scaffold that in most cases allows patients to remain mobile throughout the course of treatment.
The numerous variety of constructs afforded by the FusionFrame™ provides a systematic platform for ensuring stability, re-aligning bones, applying compressive forces or controlling the distraction of bone fragments over a period of time. The FusionFrame™ consists of externally mounted Rings and ancillary components that are interconnected with threaded rods and/or telescoping struts. The construct is attached to the bone with a combination of percutaneously applied tensioned Wires and/or Half-Pins. Telescoping struts with compression/distraction nuts may be attached to the frame to systematically control the gaps between bone fragments and distance between Rings to manage a variety of pathologies. Threaded rods or struts may be used to reduce and compress fracture zones, lengthen limbs and even correct deformities.
5
Indications for Use per FORM FDA 3881
The FusionFrame Ring Lock System is indicated for:
- Stabilization of fractures and osteotomies;
- Bone deformity correction of lower extremities;
- Arthrodesis of the rear foot, mid foot and ankle joint; and
- · Limb Lengthening in pediatric and adult patients.
Indications for Use Characteristics Comparison
Both the subject and predicate devices share the same Indications for Use and Intended use.
Technological Characteristics Comparison with the predicate device per 21 CFR 807.92(a)(6)
The technological characteristics comparison demonstrates that the subject device is substantially equivalent in intended use, design, materials, and operational principles to the previously cleared predicate devices.
Basis of Substantial Equivalence per 21 CFR 807.100(b)(2)(ii)(A)
The substantial equivalence of the subject device was determined as per the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]' and the technological characteristics which include materials, design, operational principles and other device features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A).
The subject device is a modification to the previously cleared FUSION MEDICAL RING LOCK SYSTEM (K100857) and contains components and features that are similar to the predicate device.
The performance testing, device comparison, and dimensional analysis demonstrate that the subject device and features are the same or substantially equivalent to the predicate devices identified throughout this 510(k) submission. The data generated from the subject device design verification test reports support a finding of substantial equivalence regarding the device comparison, dimensional analysis, device specifications, and design characteristics.
Performance Data Non-Clinical Test per 21 CFR 807.92(b)(1)
6
Non-clinical laboratory testing was performed on the worst-case subject device to determine substantial equivalence. The following testing was performed with reference to ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices:
- Static Torsion Test and Cantilever bend test on Half pins
- Static Axial Compression Testing on Struts ●
Design Verification testing demonstrated that the subject device is substantially equivalent to the currently marketed predicate devices.
Animal Study
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject device has the same intended use and technological characteristics as the predicate devices. The design verification data support a finding of substantial equivalence of the subject device and demonstrate that the subject device will perform as intended in the specified use conditions.