(156 days)
No
The summary describes a mechanical implant made of titanium alloy. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies rely on engineering analysis and material comparison, not data-driven algorithmic evaluation.
Yes.
The device is intended to treat a medical condition (hyperpronated foot and subtalar joint instability) by blocking excessive pronation, which is a therapeutic action.
No
The device is described as an implant intended to treat a physical condition (hyperpronated foot and stabilize the subtalar joint) by blocking displacement, rather than diagnosing a condition.
No
The device description explicitly states the device is a one-piece implant made of medical grade Titanium Alloy, indicating it is a physical hardware device, 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The provided description clearly states that the Memometal Technologies' SubFix Arthroereisis Implant is an implantable device made of titanium alloy, intended to be surgically placed in the sinus tarsi of the foot.
- Intended Use: The intended use is to treat a physical condition (hyperpronated foot) by stabilizing a joint within the body.
The device is a surgical implant, not a diagnostic test performed on bodily fluids or tissues.
N/A
Intended Use / Indications for Use
The Memometal Technologies' SubFix Arthroereisis Implant is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.
The SubFix Arthroereisis Implants are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Memometal Implant is a one-piece device made of medical grade Titanium Alloy, Ti6A14V. The implant is available in 5 sizes ranging from 6.5 mm to 11.5 in diameter. No new materials or processes are used in the development of this implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, subtalar joint
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)
An engineering analysis and a material comparison to various predicate devices were used to help demonstrate equivalence.
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.
K960692 KMI Subtalar MBA® Arthroereisis Implant (now owned by Intregra), K031155 Osteomed Talar-Fit™ Subtalar Arthroereisis Implant, K032902 Nexa Orthopedics, INC Subtalar, K041289 Arthroereisis Implant Talus of Vilex (TOV), K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm
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.
K792670 Wright Medical Smith Sta-Peg, K033046 Nexa Orthopedics Subtalar Peg ASI, K051611 KMI MBA™ Resorb, K071456 Arthrex Pro Stop Plus
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
§ 888.3040 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
K093820 '1/2
510(k) Summary as required by section 807.92(c)
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | May 12, 2010 | MAY 19 2010 |
|---|---|---|
| Applicant: | Memometal Technologies | |
| c/o Mr. Gilles Audic | ||
| Quality Manager | ||
| Rue Blaise Pascal | ||
| Campus De Ker Lann | ||
| Bruz, France 35170 | ||
| 332-99-055066 | ||
| U.S.A. Contact: Joe Clift | ||
| (901) 680-6221 | ||
| Common Name: | Subtalar Arthroereisis Implant | |
| Device Trade Name: | SubFix Arthroereisis Implant | |
| Device Classification Name: | Smooth or threaded metallic bone fixation | |
| fastener | ||
| Device Classification: | Class II | |
| Reviewing Panel: | Orthopedic | |
| Regulation Number: | 888.3040 | |
| Product Code: | HWC |
Registration Number: Owner Operator Number:
K960692 KMI Subtalar MBA® Arthroereisis Implant (now owned by Intregra) K031155 Osteomed Talar-Fit™ Subtalar Arthroereisis Implant K032902 Nexa Orthopedics, INC Subtalar K041289 Arthroereisis Implant Talus of Vilex (TOV) K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm K792670 Wright Medical Smith Sta-Peg K033046 Nexa Orthopedics Subtalar Peg ASI K051611 KMI MBA™ Resorb K071456 Arthrex Pro Stop Plus 3004082045 9096224
Device Description:
Predicate Devices:
The Memometal Implant is a one-piece device made of medical grade Titanium Alloy, Ti6A14V. The implant is available in 5 sizes ranging from 6.5 mm to 11.5 in diameter. No new materials or processes are used in the development of this implant.
| Memometal Technologies | |
|---|---|
| SubFix Arthroereisis Implant 510(k) Premarket Notification | REV. 4 |
| May 12, 2010 |
Confidential Section 6, Page 1 of 2
1
Indications for Use:
The Memometal Technologies' SubFix Arthroereisis Implant is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.
The SubFix Arthroereisis Implants are intended for single use only.
Comparison to Predicate Device:
The Memometal device has numerous similarities to the predicate devices which are summarized here. The SubFix device and predicate devices K960692 KMI Subtalar MBA® Arthroereisis Implant (now owned by Intregra) and K031155 Osteomed Talar-Fit™ Subtalar Arthroereisis Implant have the same indications for use and share technical characteristics of being cannulated, threaded screw implants. Each device is placed into the sinus tarsi of the foot, allowing subtalar joint motion while blocking excessive pronation. Most systems are cannulated for ease of implantation. The SubFix device and predicate device K032902 Nexa Orthopedics. INC Subtalar are comparably sized. The SubFix device and predicate devices K041289 Arthroereisis Implant Talus of Vilex (TOV) K080280 Instratek, Inc. Sub-Talar Lok, Model 7-11 mm have similar characteristics of being is titanium color anodized.
Performance Data:
An engineering analysis and a material comparison to various predicate devices were used to help demonstrate equivalence.
Summary:
The Memometal device and the predicate devices have the similar design characteristics and intended use. The new device is substantially equivalent to the predicate devices and should not introduce new concerns in terms of safety or effectiveness.
Memometal Technologies SubFix Arthroereisis Implant 510(k) Premarket Notification
REV. 4 May 12, 2010
Confidential Section 6, Page 2 of 2
2/2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three overlapping wing-like shapes, oriented towards the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Memometal Technologies % Mr. Gilles Audic Rue Blaise Pascal Campus De Ker Lann Bruz, France 35170
MAY 1 9 2010
Re: K093820
Trade/Device Name: SubFix Arthroereisis Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 31, 2010 Received: April 16, 2010
Dear Mr. Audic:
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. Gilles Audic
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,
Barbara Buehum
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): _K093820 Device Name: SubFix Arthroereisis Implant Indications for Use:
The Memometal· Technologies' SubFix Arthroereisis Implant is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing subtalar joint motion but blocking excessive pronation and the resulting sequela.
The SubFix Arthroereisis Implants are intended for single use only.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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)
Smita for mkm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093820 Memometal Technologies SubFix Arthroereisis Implant 510(k) Premarket Notification
Confidential Section 5, Page 1 of 1