← Product Code [KWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH) · K191966 # NewPrim System (K191966) _Brm Extremities · KWH · Feb 13, 2020 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K191966 ## Device Facts - **Applicant:** Brm Extremities - **Product Code:** [KWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH.md) - **Decision Date:** Feb 13, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3720 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The BRM Extremities NewPrim device is intended for use in: - Hallux rigidus or hallux limitus; - Painful rheumatoid arthritis; - Hallux abducto valgus associated with arthritis; - Unstable or painful joint from previous surgery ## Device Story NewPrim system is double-stemmed, constrained, silicone prosthesis; replaces osteo-cartilaginous heads of first metatarsophalangeal joint. Implant acts as joint spacer between resected head of first metatarsal and base of proximal phalanx. Stems fit into intramedullary canals of first metatarsal joint. Device includes optional proximal and distal grommets. Used by orthopedic surgeons in clinical settings to restore joint function and alleviate pain in patients with degenerative or post-surgical joint conditions. ## Clinical Evidence Bench testing only. Static tensile testing demonstrated strength equivalent to reference predicate. Fatigue testing confirmed performance under displacements exceeding expected physiologic levels. Device complies with AAMI ST-72 LAL testing requirements. ## Technological Characteristics Double-stemmed, constrained, silicone elastomer prosthesis. Dimensions and geometry designed for first metatarsophalangeal joint replacement. Includes optional proximal and distal grommets. Sterilization and specific ASTM material standards not explicitly detailed, but device meets AAMI ST-72 requirements for orthopedic devices. ## Regulatory 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 - RTS Flexible 1st MPJ Implant w/ Grommets ([K153609](/device/K153609.md)) ## Reference Devices - Integra Classic Great Toe Implant ([K023562](/device/K023562.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration". February 13, 2020 BRM Extremities % Margeaux Rogers Associate Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001 Re: K191966 Trade/Device Name: NewPrim System Regulation Number: 21 CFR 888.3720 Regulation Name: Toe Joint Polymer Constrained Prosthesis Regulatory Class: Class II Product Code: KWH Dated: January 16, 2020 Received: January 16, 2020 Dear Margeaux Rogers: 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). 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Sincerely, For Ting Song, 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 {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. ### 510(k) Number (if known) 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 Device Name BRM Extremities NewPrim System Indications for Use (Describe) The BRM Extremities NewPrim device is intended for use in: - Hallux rigidus or hallux limitus; - Painful rheumatoid arthritis; - Hallux abducto valgus associated with arthritis; - Unstable or painful joint from previous surgery | 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary | Manufacturer: | BRM Extremities | |---------------------|--------------------------------------------------------| | | Via Ciro Menotti 10 | | | 20129 Milano, Italy | | Contact: | Ing. Andrea De Maglio | | | Regulatory Affairs Manager | | | BRM Extremities Srl | | | Tel. 02.36735123 | | | Cell. 389.1938034 | | | Email. A.demaglio@brm-extremities.com | | Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC | | | 1050 K Street, NW, Suite 1000 | | | Washington, DC 20001 | | | Phone: 202.552.5800 | | Date Prepared: | February 12, 2020 | | Device Trade Name: | BRM Extremities NewPrim System | | Device Common Name: | Toe joint polymer constrained prosthesis | | Classification: | 21 CFR 888.3720 – Prosthesis, Toe, Constrained Polymer | | | Class II | | Product Codes: | KWH | ## Indications for Use: The BRM Extremities NewPrim device is intended for use in: - Hallux rigidus or hallux limitus; - - Painful rheumatoid arthritis; - - Hallux abducto valgus associated with arthritis; - - Unstable or painful joint from previous surgery - {4}------------------------------------------------ ### Device Description: The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx. ## Predicate Devices: The NewPrim system is substantially equivalent to the primary predicate RTS Flexible 1st MPJ Implant w/ Grommets (K153609) and reference predicate Integra Classic Great Toe Implant (K023562). ## Substantial Equivalence: The NewPrim System and the legally marketed predicate device have the same intended use and indications for use, similar dimensions, geometry and materials. The stems of the devices are fit into the intramedullary canals of the first metatarsal joint. The devices are constrained and made of silicone elastomer. The devices also have proximal and distal grommets that may be used with the silicone implant. Static tensile testing demonstrated that the static strength of the subject device is substantially equivalent to that of the reference predicate (K023562). Results of fatigue testing demonstrated that the NewPrim spacer performs as intended in fatigue displacements more extreme than expected with physiologic implant displacement. Additionally, the NewPrim System is in compliance with LAL testing requirements for orthopedic devices per AAMI ST-72 testing. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K191966](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWH/K191966) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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