RTS Lesser MTP Implant System

K173491 · In2bones USA, LLC · KWH · Feb 23, 2018 · Orthopedic

Device Facts

• Record ID: K173491
• Device Name: RTS Lesser MTP Implant System
• Applicant: In2bones USA, LLC
• Product Code: KWH · Orthopedic
• Decision Date: Feb 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The RTS® Lesser MTP Implant is a one-piece, medical-grade silicone elastomer prosthesis designed for the lesser metatarsophalangeal joint. It functions as a constrained toe joint replacement to address joint dislocation, pain, stiffness, or deformity. The device is implanted by a surgeon in a clinical setting. It acts as a mechanical spacer/stabilizer to restore joint function and alleviate pain. The system includes associated sterile instruments made of stainless steel and polymers. The device is intended for prescription use.

Clinical Evidence

Bench testing only. Validations performed on cleaning, packaging, and sterilization of implants and instruments. Engineering analysis, including Finite Element Analysis, was conducted to demonstrate substantial equivalence.

Technological Characteristics

One-piece medical-grade silicone elastomer implant. Available in three sizes. Associated instruments constructed from medical-grade stainless steel and polymers. Mechanical constrained prosthesis design.

Indications for Use

Indicated for patients requiring treatment for lesser metatarsophalangeal (MTP) joint dislocation, pain from rheumatoid or osteoarthritis, failed prior arthroplasties, joint stiffness, or fixed hammertoe deformity.

Regulatory Classification

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.

Predicate Devices

• OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System (K022886)
• Integra Lesser Metatarsal Phalangeal Implant (K023531)

Reference Devices

• In2Bones RTS® Flexible 1st MPJ Implant w/Grommets System (K153609)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K173491

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)

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#### 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<br>6060 Poplar Ave, Suite 380<br>Memphis, TN 38119<br>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.