(357 days)
Not Found
No
The summary describes a physical implant system and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a hemiarthroplasty system used for uncemented joint treatment of arthritis, indicating its role in treating a medical condition.
No
The device is an implant system designed for surgical joint resurfacing, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components (metatarsal and phalangeal implants made from Cobalt Chrome) designed for surgical implantation, which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The Montross Extremity Medical Hemi Implant System is a surgical implant designed to be placed inside the human body to resurface a joint. It is used for the treatment of arthritis in the first metatarsal joint.
- Lack of Specimen Examination: The device does not examine any specimens derived from the human body. It is a physical implant.
Therefore, based on the provided information, the Montross Extremity Medical Hemi Implant System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment with arthritis in the first metatarsal joint in the presence of good bone stock.
Indications include:
- Hallux valgus or Hallux limitus
- Hallux rigidus
- Unstable or painful metatarsallphalangeal (MTP) joint
Product codes
KWD
Device Description
The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component (four sizes for each component) designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. The implants are made from Cobalt Chrome per ASTM F-1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
1st metatarsal head or the base of the proximal phalanx (toe joint, first metatarsal joint, metatarsallphalangeal (MTP) 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)
Bench testing was performed, including Static Pullout and Dynamic Pullout tests. The results indicate that the strength of the Montross Extremity Medical Hemi Implant System is substantially equivalent to the predicate devices for the intended use joint load bearing and can withstand the expected physiologic loads.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.
0
April 19, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Montross Extremity Medical % Lee Strnad President Intrepid Orthopedics, LLC 3953 Humphrey Road Richfield, Ohio 44286
Re: K221220
Trade/Device Name: Montross Extremity Medical Hemi Implant System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe Joint Phalangeal (Hemi-Toe) Polymer Prosthesis Regulatory Class: Class II Product Code: KWD Dated: February 20, 2023 Received: February 22, 2023
Dear Lee Strnad:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir-S
Jesse Muir, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221220
Device Name
Montross Extremity Medical Hemi Implant System
Indications for Use (Describe)
The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment with arthritis in the first metatarsal joint in the presence of good bone stock.
Indications include:
-
Hallux valgus or Hallux limitus
-
Hallux rigidus
-
Unstable or painful metatarsallphalangeal (MTP) joint
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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510(k) Summary
Submitter Information
| Applicant: | Montross Extremity Medical
20 Belle Air Rd
Colorado Springs, CO, 80906 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lee A. Strnad
Management Representative
Intrepid Orthopedics
3953 Humphrey Rd
Richfield, OH 44286
(440) 465-4321 |
| Date Prepared: | 4/28/22 |
| Name of Device: | Montross Extremity Medical Hemi Implant System |
| Common Name: | Toe joint phalangeal (hemi-toe) polymer prosthesis |
| Classification Name: | 21 CFR 888.3730 (Hemi-Toe) |
| Product Code/Panel: | KWD/Orthopedic |
| Predicate Devices: | K092047 - Ascension® Metal Great Toe System (Primary
Predicate)
K971047 - Futura Biomedical Metal Hemi Toe Implant
(Additional Predicate) |
Intended Use
The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthroplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock.
Indications for Use
The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock.
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Indications include:
- Hallux valgus or Hallux limitus
- Hallux rigidus
- Unstable or painful metatarsallphalangeal (MTP) joint
Device Description
The Montross Extremity Medical Hemi Implant System consists of a metatarsal component and a phalangeal component (four sizes for each component) designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthmoplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. The implants are made from Cobalt Chrome per ASTM F-1537.
Technological Characteristics
The Montross Extremity Medical Hemi Implant System has the same intended use as the predicate devices. The Montross Extremity Medical Hemi Implant System has similar indications for use as the predicate devices. The Montross Extremity Medical Hemi Implant System is manufactured from the same materials as the predicate devices. Montross Extremity Medical Hemi Implants are manufactured from Cobalt Chrome per ASTM F-1537. The range of sizes of the Montross Extremity Medical Hemi Implant System is similar to the predicate devices.
Nonclinical Testing
The following performance testing has been performed:
Bench testing
- Static Pullout
- Dynamic Pullout ●
The results of this non-clinical testing show that the strength of the Montross Extremity Medical Hemi Implant System is substantially equivalent to the predicate devices for the intended use joint load bearing and can withstand the expected physiologic loads.
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Sterilization and reprocessing validation
Montross Extremity Medical Hemi Implant System is provided non-sterile and the end user is provided with validated (to establish an SAL of 10^-6) pre-vacuum steam sterilization cycle parameters. The end user is provided with validated reprocessing instructions for the reusable instruments.
Biocompatibility
Biocompatibility assessment was performed on Montross Extremity Medical Hemi Implant System to ensure that the device is biocompatible.
Conclusion
The overall technology characteristics and mechanical performance data lead to the conclusion that the Montross Extremity Medical Hemi Implant System is substantially equivalent to the predicate devices.