(97 days)
Not Found
Not Found
No
The document describes a physical implant and its intended use, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as an implant used for the "treatment of the hyperpronated foot and stabilization of the subtalar joint," and it is designed to block certain displacements, indicating a therapeutic purpose.
No
Explanation: The device description states it is a titanium implant used for treatment of the foot, not for diagnosis. Its intended use is to mechanically block talus displacement, which is a therapeutic function.
No
The device description explicitly states it is a "one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot," indicating it is a physical implant, not software.
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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device description: The Metasurg subtalar implant is a physical device made of titanium that is implanted into the foot. It is a surgical implant used to treat a structural issue.
- Intended Use: The intended use is to treat a physical condition (hyperpronated foot, subtalar instability) by providing mechanical support and stabilization. It does not involve testing or analyzing biological specimens.
Therefore, based on the provided information, the Metasurg subtalar implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Indications include:
- Severe pronation
- Calcaneal valgus deformity
- Plantarflexed talus
- Failed correction with long term orthotic treatment
- Congenital and painful flatfoot deformity
- Repair of tarsal coalitions
- Subtalar instability
- Posterior tibial tendon dysfunction
- Paralytic flat foot deformity
The Metasurg subtalar implants are intended for single use only.
Product codes
HWC
Device Description
The Metasurg Subtalar Implant is a one-piece device made of titanium intended to be implanted into the sinus tarsi of the foot. The implant is offered in 5 sizes ranging from 8mm to 12mm in diameter. The implant is used in the treatment of the talus relative to the calcaneus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, sinus tarsi
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
/1,
510(k) Summary
:
AUG - - 9 9 2011
| Date Prepared: | May 3, 2011 |
|---|---|
| Sponsor: | Metasurg |
| 16350 Park Ten Place, Suite 101 | |
| Houston, TX 77084 | |
| Company Contact: | Joshua Scott |
| Phone: (281) 398-5656 | |
| Fax: (281) 398-5660 | |
| Device Trade Name: | Metasurg Subtalar Implant |
| Classification Name: | Smooth & threaded metallic bone fixation fasteners (21 |
| CFR 888.3040, Product Code HWC, Class II) | |
| Common Name: | Subtalar Arthrorisis Implant |
| Substantial Equivalence: | Documentation is provided which demonstrates the Metasurg |
| Subtalar Implant to be substantially equivalent to other legally | |
| marketed devices. | |
| Device Description: | The Metasurg Subtalar Implant is a one-piece device made of |
| titanium intended to be implanted into the sinus tarsi of the foot. | |
| The implant is offered in 5 sizes ranging from 8mm to 12mm in | |
| diameter. The implant is used in the treatment of the talus | |
| relative to the calcaneus. | |
| Intended Usage: | The Metasurg subtalar implant is indicated for use in the |
| treatment of the hyperpronated foot and stabilization of the | |
| subtalar joint. It is designed to block forward, downward and | |
| medial displacement of the talus, thus allowing normal subtalar | |
| joint motion but blocking excessive pronation and the resulting | |
| sequela. | |
| Indications include: | |
| • Severe pronation | |
| • Calcaneal valgus deformity | |
| • Plantarflexed talus | |
| • Failed correction with long term orthotic treatment | |
| • Congenital and painful flatfoot deformity | |
| • Repair of tarsal coalitions | |
| • Subtalar instability | |
| • Posterior tibial tendon dysfunction | |
| • Paralytic flat foot deformity | |
| The Metasurg subtalar implants are intended for single use only. | |
| Material: | Titanium Alloy (Ti 6Al-4V ELI) |
Section 5 - Page 1 of 1
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. 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 Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Metasurg % Mr. Joshua Scott 16350 Park Ten Place Suite 101 Houston, Texas 77084
- 9 2011 માંદિ
Re: K111265
Trade/Device Name: Metasurg Subtalar Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 19, 2011 Received: July 20, 2011
Dear Mr. Scott:
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
2
Page 2 - Mr. Joshua Scott
CFR Part 807); labeling (21 CFR Part 801); medical device 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 go to http://www.fda.gov/AboutlTDA/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/ReportalProblem/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
3
Indications for Use
510(k) Number: Pending_ K11/ 265
Device Name: Metasurg Subtalar Implant
Indications for Use:
The Metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Indications include:
- Severe pronation .
- Calcaneal valgus deformity .
- Plantarflexed talus .
- Failed correction with long term orthotic treatment .
- Congenital and painful flatfoot deformity .
- . Repair of tarsal coalitions
- Subtalar instability .
- Posterior tibial tendon dysfunction .
- Paralytic flat foot deformity .
The Metasurg subtalar implants are intended for single use only.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WIRTE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number. 12111256
Section 4 - Page 1 of 1