(102 days)
No
The summary describes a physical implant and surgical instruments, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is intended for the treatment of various medical conditions related to the lesser metatarsophalangeal joint, such as dislocation, pain from arthritis, and hammertoe deformity, which directly addresses disease or injury.
No
The device is an implant for the treatment of various conditions and deformities of the lesser metatarsophalangeal joint, not for diagnosing them.
No
The device description explicitly states it is a one-piece implant manufactured from Medical Grade Silicone Elastomer and includes associated sterile instruments made of stainless steel and polymer materials, indicating it is a physical medical 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Description and Intended Use: The RTS® Lesser MTP Implant is a physical implant made of silicone elastomer that is surgically placed within the body to treat specific joint conditions. It does not analyze biological specimens.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The RTS® Lesser MTP Implant is intended for use in the treatment of:
- · Partial or complete dislocation of the lesser metatarsophalangeal joint
- · Pain associated with either rheumatoid or osteoarthritis
- · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
- · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
- · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
Product codes
KWH
Device Description
The In2Bones USA RTS® Lesser MTP Implant is a one-piece device manufactured from Medical Grade Silicone Elastomer. The implant is available in three sizes. The associated sterile instruments are made of medical grades of stainless steel and polymer materials
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser metatarsophalangeal joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering analysis including Finite Element Analysis was also performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 23, 2018
In2Bones USA, LLC % Christine Scifert Exec VP MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119
Re: K173491
Trade/Device Name: RTS Lesser MTP Implant System Regulation Number: 21 CFR 888.3720 Regulation Name: Toe joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KWH Dated: January 24, 2018 Received: January 26, 2018
Dear Ms. Scifert:
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 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);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name RTS® Lesser MTP Implant System
Indications for Use (Describe)
The RTS® Lesser MTP Implant is intended for use in the treatment of:
- · Partial or complete dislocation of the lesser metatarsophalangeal joint
- · Pain associated with either rheumatoid or osteoarthritis
- · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
- · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
- · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
RTS® Lesser MTP Implant System January 24, 2018
| Company: | In2Bones USA, LLC
6060 Poplar Ave, Suite 380
Memphis, TN 38119
901-260-7931 |
|--------------------|--------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Company Contact: | Rebecca Wahl |
| Trade Name: | RTS® Lesser MTP Implant System |
| Common Name: | Polymer toe Prosthesis |
| Classification: | II |
| Regulation Number: | 888.3720 - Toe Joint Polymer Constrained Prosthesis |
| Panel: | 87-Orthopedic |
| Product Code(s): | KWH |
Device Description: The In2Bones USA RTS® Lesser MTP Implant is a one-piece device manufactured from Medical Grade Silicone Elastomer. The implant is available in three sizes. The associated sterile instruments are made of medical grades of stainless steel and polymer materials
Indications for Use: The RTS® Lesser MTP Implant is intended for use in the treatment of:
- · Partial or complete dislocation of the lesser metatarsophalangeal joint
- · Pain associated with either rheumatoid or osteoarthritis
- · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
- · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
• Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
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Primary Predicate
- . K022886 – OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System Additional Predicate
- . K023531 - Integra Lesser Metatarsal Phalangeal Implant Reference Device
- K153609 In2Bones RTS® Flexible 1st MPJ Implant w/Grommets System .
The subject RTS® Lesser MTP Implant made of Silicone Elastomer has demonstrated to be substantially equivalent to the previously cleared OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System and the Integra Lesser Metatarsal Phalangeal Implant as the products are similar in indications, materials and geometry.
Performance Testing: Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering analysis including Finite Element Analysis was also performed. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified
Conclusion
The RTS® Lesser MTP Implant when compared to the predicate have the same intended use and indications for use, technological characteristics, and principals of operation. Thus the RTS® Lesser MTP Implant design characteristics do not raise any new types of questions of safety or effectiveness and thus is substantially equivalent to the predicate device.