(62 days)
Not Found
No
The device description focuses on mechanical components and their function in bone stabilization and correction. There is no mention of AI, ML, image processing, or data-driven analysis in the provided text.
Yes
The device is used for stabilization of fractures, deformity correction, arthrodesis, and limb lengthening, which are all therapeutic interventions.
No
The device description and intended use indicate it is an orthopedic fixation system used for surgical procedures like fracture stabilization and deformity correction, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of aluminum and stainless steel (rings, posts, washers, hinges), indicating it is a hardware-based medical device, not software-only.
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. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided description clearly states the device is a "Circular Frame and Footplate system" used for "Stabilization of fractures & Osteotomy Bone deformity correction of lower extremities Arthrodesis of the rear foot, mid foot, and ankle joint. Limb lengthening in pediatric and adults." This involves physically interacting with and supporting bone structures within the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is purely mechanical and structural.
Therefore, based on the provided information, the Fusion Medical Ring Lock system is a surgical device used for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
Stabilization of fractures & Osteotomy
Bone deformity correction of lower extremities.
Arthrodesis of the rear foot, mid foot and ankle joint.
Limb lengthening in pediatric and adults.
Product codes (comma separated list FDA assigned to the subject device)
KTT, CRF-21 888.3030
Device Description
The Fusion Medical Ring Lock system is a Circular Frame and Footplate system, used in lower extremity Stabilization and Deformity Correction. Wires are placed in the bone and attached to the frame with wire fixation bolts. The wires are then tensioned to support the bone. Rings are made of aluminum 6061 T6. Posts are used to capture wires that are elevated off the frame. Posts are made of 17-4 PH stainless steel. Washers are used to fine tune the elevation, and hinges are used for gradual correction of bone.
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 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)
Study Type: Cross sectional engineering analysis
Key Results: Fusion Medical Ring Lock system is equivalent to the Vilex Frame. There was no change to the design or size to decrease structural strengths in the rings or components and their material.
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.
0
John J Riccio (Fusion Medical Corp.) 44 Church St West Haven CT. 06516
Phone: (203) 823-8511 Fax: (860) 454-7562
MAY 8 7 2010
Summary Fusion Medical Ring Lock System
| Date Of submission: | 3/12/10 |
|---|---|
| Type of submission: | 510(K) |
| Reason for submission: New Device | |
| Product code: | KTT, CRF-21 888.3030 |
| Device class: | II |
| Classification panel: | Orthopedics |
| Predicate devices: | |
| K052196 | Vilex |
| Common Name: | External Ring Fixation |
| Device Trade Name: | Fusion Medical Ring Lock System |
| Establishment Operations: | Manufacture |
| Indications for use: | Stabilization of fractures & Osteotomy |
| Bone deformity correction of lower extremities. | |
| Arthrodesis of the rear foot, mid foot and ankle joint. | |
| Limb lengthening in pediatric and adults. | |
| Submitter: | John Riccio |
Device Description:
The Fusion Medical Ring Lock system is a Circular Frame and Footplate system, used in lower extremity Stabilization and Deformity Correction. Wires are placed in the bone and attached to the frame with wire fixation bolts. The wires are then tensioned to support the bone. Rings are made of aluminum 6061 T6. Posts are used to capture wires that are elevated off the frame. Posts are made of 17-4 PH stainless steel. Washers are used to fine tune the elevation, and hinges are used for gradual correction of bone.
p. 1 of 2
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Technological Characteristics:
The technological characteristics between the Vilex Frame (K052196) and the Fusion Frame are identical, the only design difference is our tabs on the rings have 3 holes; Vilex has 2 holes on their tabs. Both are made from the same material, aluminum alloy. The Vilex Frame has the same sizes as the Fusion Frame: 140mm, 160mm, 180mm, and 205mm. Rods are the same material and length, as are other components. The Vilex xfix frame has the same indication for use.
Summary of Testing:
Cross sectional engineering analysis shows the Fusion Medical Ring Lock system is equivalent to the Vilex Frame. There was no change to the design or size to decrease structural strengths in the rings or components and their material.
Conclusion:
Fusion Medical Ring Lock System is equivalent to devices already marketed for the same indications.
p. 2 of 2.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. John J. Riccio 44 Church Street West Haven, Connecticut 06516
MAY 2 7 2010
Re: K100857
Trade/Device Name: Fusion Medical Ring Lock System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 12, 2010 Received: March 26, 2010
Dear Mr. Riccio:
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. John J. Riccio
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(K) Number (if known): K100857
Device Name: Fusion Medical Ring Lock System
Indications for Use: Stabilization of fractures & Osteotomy Bone deformity correction of lower extremities Arthrodesis of the rear foot, mid foot, and ankle joint. Limb lengthening in pediatric and adults.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND /OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please Do Not Write Below This Line-Continue On Another Page Of Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ouster for mxn
(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100857