(334 days)
Not Found
No
The document describes a mechanical implant and does not mention any AI/ML terms, image processing, or data sets related to training or testing AI/ML models.
Yes
The device is described as "intended to treat hyperpronated foot, and stabilize the subtalar joint" and addresses specific medical conditions like "painful flat foot" and "posterior tibial tendon deformity," which are therapeutic applications.
No
The device description clearly states it is an implant for treatment, not for diagnosis. Its function is to block displacement and act as a spacer, which are therapeutic actions.
No
The device description clearly states it is a one-piece device made of titanium intended to be implanted, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat a physical condition (hyperpronated foot, subtalar instability, etc.) by being surgically implanted into the body. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical implant made of titanium, designed to be placed within the body to modify its structure and function. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely mechanical and therapeutic.
Therefore, the Fusion Medical STI is a medical device, specifically an implantable orthopedic device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fusion Medical STI (Subtalar Implant) is intended to treat hyperpronation of the foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and resulting sequela.
Example are:
Subtalar instability Painful flat foot Congenital flat foot Paralytic Flat foot
Tarsal Coalitions posterior tibial tendon deformity Flat foot treatment in children and adolescent
The Fusion Medical STI is intended to treat hyperpronated foot, and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion, but blocking excessive pronation and resulting sequela.
Examples are:
Subtalar instability, painful flat foot, congenital flat foot, paralytic flat foot, tarsal coalitions, posterior tibial tendon deformity and flat foot treatment in children and adolescents.
Product codes (comma separated list FDA assigned to the subject device)
87 HWC
Device Description
The Fusion Medical STI (Subtalar Implant) is a one-piece device made of titanium (6AL-4V ELI) intended to be implanted into the sinus tarsi of the foot. The implant will be available in 5 sizes. 8mm-12mm diameters. The implant that is used in the treatment of excess motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Foot, subtalar joint, sinus tarsi
Indicated Patient Age Range
Adult and children (Flat Foot)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K0817SS
510(K) Summary
Summary of 510(K) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | June 12, 2008 |
|---|---|
| Applicant: | John Riccio (Fusion Medical) |
| 1663 South Main St | |
| Waterbury, CT 06706 | |
| Telephone: | 203-823-8511 |
| Fax: | 860-454-7562 |
| Contact: | John Riccio |
MAY 20 2009
| Device Name: | Subtalar Arthrorisis Implant |
|---|---|
| Device Trade Name: | STI (Subtalar implant) |
Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Devices:
Class II Orthopedic 888.3040 87 HWC K031155- Osteomed Subtalar Implant K0322902-(Nexa) Futura Subtalar Implant
Device Description:
The Fusion Medical STI (Subtalar Implant) is a one-piece device made of titanium (6AL-4V ELI) intended to be implanted into the sinus tarsi of the foot. The implant will be available in 5 sizes. 8mm-12mm diameters. The implant that is used in the treatment of excess motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.
Indication for Use:
The Fusion Medical STI (Subtalar Implant) is intended to treat hyperpronation of the foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and resulting sequela.
Example are:
Subtalar instability Painful flat foot Congenital flat foot Paralytic Flat foot
Tarsal Coalitions posterior tibial tendon deformity Flat foot treatment in children and adolescent
1
1
K081755 2/3
Comparison to Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the Futura CSI 510(k) K032902.
Regulatory Class: II 87 HWC Product Code:
Table 1. Comparison of Fusion Medical STI and Futura Biomedical Subtalar Implant
| Item | Fusion | Futura |
|---|---|---|
| Product Name: | STI Subtalar Implant | Subtalar Arthrorisis Implant |
| Use: | Single Use | Single Use |
| Fixation: | Screw | Screw |
| Constraint: | Non Constrained | Non Constrained |
| Material: | Titanium 6AL-4V ELI | Titanium 6AL-4V ELI |
| Sizes: | 5 | 6 |
| Indications | The Fusion Medical STI | |
| implant is intended to treat | ||
| hyperpronated foot and stabilize | ||
| the subtalar joint. It is intended to | ||
| treat forward, downward and medial | ||
| displacement of the talus, thus | ||
| allowing normal subtalar joint | ||
| motion but blocking excessive | ||
| pronaton and resulting in sequela. | The Futura Subtalar arthrorisis implant | |
| is intended to treat hyreppronated foot and | ||
| stabilize the subtalar joint. It is intended to | ||
| forward, downward and medial displacement | ||
| of the talus, thus allowing normal subtalar joint | ||
| motion, but blocking excessive pronation and | ||
| resulting in sequela. | ||
| Examples Include: | ||
| Congenital flat foot | Congenital flat foot | |
| Tarsal coalition | Tarsal coalition | |
| Painful flat foot | Painful flat foot | |
| Posterior tibial tendon dysfunction | Posterior tibila tendon dysfunction | |
| Paralytic flat foot. | Paralytic flat foot | |
| Subtalar instability | Subtalar instability | |
| Foot treatment of adult and children | ||
| (Flat Foot) | Foot treatment of adult and children | |
| (Flat Foot) |
2
K081755 3/3
3
Similarities of the Fusion Medical STI (Subtalar Implant) and Nexas Futura CSI Implant include the following:
Both devices are intended for surgical implantation longer than 30 days. No new materials are introduced in either product. Both devices are made of industry standard materials. Both devices are placed into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronaton and resulting in sequela. Both devices are similar in size; They have the same indications of use.
Summary:
The Fusion Medical STI and the (Nexa) Future CSI, have the same indications of use. The design of the STI (Fusion Medical) and The CSI (Nexa) are comparable. The New Fusion Medical STI implant is substantially equivalent to the predicate device currently on the market.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
::
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
MAY 20 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fusion Medical % Mr. John Riccio 1663 South Main Street Waterbury, Connecticut 06706
Re: K081755
Trade/Device Name: Fusion Medical STI System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 4, 2009 Received: May 4, 2009
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 The 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.
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
4
Page 2 - Mr. John Riccio
(240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative تر and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K081755
Device Name: Fusion Medical STI System
Indications for Use:
The Fusion Medical STI is intended to treat hyperpronated foot, and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion, but blocking excessive pronation and resulting sequela.
Examples are:
Subtalar instability, painful flat foot, congenital flat foot, paralytic flat foot, tarsal coalitions, posterior tibial tendon deformity and flat foot treatment in children and adolescents.
× 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)
Onuta 2 Pts
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K081755