← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K140792 # SALVATION 3DI PLATING SYSTEM (K140792) _Wrightmedicaltechnologyinc · HRS · May 22, 2014 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K140792 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** May 22, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The SALVATION™ 3Di Plating System is indicated for the treatment of fracture stabilization/fixation, revision procedures, osteotomies, and reconstruction/arthrodesis of small bones, as well as patients with osteopenic bone. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for neuropathic osteoarthropathy (Charcot). ## Device Story SALVATION™ 3Di Plating System consists of titanium alloy plates and screws for midfoot reconstruction; includes locking and non-locking screws in various sizes/styles. Used by orthopedic surgeons in clinical settings for fracture stabilization, revision, osteotomy, and arthrodesis. Device provides mechanical fixation to stabilize small bones; supports fusion in neuropathic osteoarthropathy (Charcot) cases. Surgeon selects appropriate plate/screw configuration based on patient anatomy and bone quality; hardware implanted to provide structural support during healing. Benefits include restoration of bone alignment and stability. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing including static bending, insertion, removal, and ultimate torque analysis, plus pull-out rationale. ## Technological Characteristics Titanium alloy bone plates and screws; locking and non-locking screw options. Mechanical fixation device. No software or electronic components. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - DARCO® RPS Plates ([K061808](/device/K061808.md)) - ORTHOLOC® 3Di Recon Midfoot Plating System ([K121651](/device/K121651.md)) - Smith and Nephew VLP Foot Plating, Screw System ([K090675](/device/K090675.md)) - Smith and Nephew VLP Foot Plating, Screw System ([K110670](/device/K110670.md)) - ORTHOLOC® 3Di Ankle Plating System ([K131093](/device/K131093.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 for Wright, a company that focuses on excellence. The logo features a stylized "W" symbol to the left of the company name, which is written in bold, sans-serif font. Below the company name is the tagline "Focused Excellence" in a smaller font size. K140792 page 1 Of 2 MAY 2 2 2014 Wright Medical Technology, II 1G2 3 Cherry Road Memphis, IN 38117 901 867 997 1 wmt.com # 510(K) SUMMARY In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the SALVATION™ Beams and Bolts System. (a)(1). Submitted By: Date: Contact Person: (a)(2). Proprietary Name: Common Name: Classification Name and Reference: Device Product Code, Device Panel: (a)(3). Predicate Devices: Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 March 28, 2014 Leslie Fitch, PhD Senior Regulatory Affairs Specialist Office: (901) 867-4120 Fax: (901) 867-4190 SALVATION™ 3Di Plating System Bone Plate System 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories, Class II HRS, Orthopedic K061808: DARCO® RPS Plates K121651: ORTHOLOC® 3Di Recon Midfoot Plating System K090675, K110670: Smith and Nephew VLP Foot Plating, Screw System K131093: ORTHOLOC® 3Di Ankle Plating System # (a)(4). Device Description The SALVATION™ 3Di Plating System consists of titanium alloy plates and screws used for midfoot reconstruction. The system features plates of various sizes and styles, as well as locking and non-locking screws. {1}------------------------------------------------ # K140792 page 2 of 2 Image /page/1/Picture/1 description: The image is a close-up shot of a triangular object. The object is divided into two distinct sections. The upper section is a light color, while the lower section is a dark color. The dark section takes up the majority of the object's area. # (a)(5). INTENDED USE The SALVATION™ 3Di Plating System is indicated for the treatment of fracture stabilization/fixation, revision procedures, osteotomies, and reconstruction/arthrodesis of small bones, as well as patients with osteopenic bone. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for neuropathic osteoarthropathy (Charcot). ### (a)(6). Technological Characteristics Comparison The SALVATION™ 3Di Plating System is technologically substantially equivalent to predicate devices in material, size and bending strength. #### (b)(1). Substantial Equivalence - Non-Clinical Evidence Performance testing and analysis that demonstrated substantial equivalence includes static bending, insertion, removal, and ultimate torque, as well as a pull-out rationale. ### (b)(2). Substantial Equivalence - Clinical Evidence N/A #### (b)(3). Substantial Equivalence - Conclusions The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract shapes that resemble human figures or waves, stacked on top of each other. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 22, 2014 Wright Medical Technology, Incorporated Leslie Fitch, Ph.D., CTBS Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117 Re: K140792 Trade/Device Name: SALVATION 3Di Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: April 10, 2014 Received: April 11, 2014 Dear Dr. Fitch: 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. Ilisting 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 {3}------------------------------------------------ # Page 2 - Leslie Fitch, Ph.D., CTBS 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/McdicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Ronald P. Jean -S for - Mark N. Melkerson Director - Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K140792 Device Name SALVATION 3Di Plating System ### Indications for Use (Describe) The SALVATION™ 3Di Plaing System is indicated for the treatment of fracture stabilization/fixation, revision procedures, osteotonies, and reconstruction/arthrodesis of small bones, as well as patients with osteopenic bone. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for neuropathy (Charcot). Type of Use (Select one or both, as applicable) 2 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) # Elizabet标检验Frank -S Division of Orthopedic Devices 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." --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K140792](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K140792) **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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