MVP Cervical Plate System

K190170 · GS Medical Co., Ltd. · KWQ · May 13, 2019 · Orthopedic

Device Facts

Record IDK190170
Device NameMVP Cervical Plate System
ApplicantGS Medical Co., Ltd.
Product CodeKWQ · Orthopedic
Decision DateMay 13, 2019
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3060
Device ClassClass 2
AttributesTherapeutic

Intended Use

The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: • Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - · Spondylolisthesis - · Trauma (including fracture or dislocation) - · Spinal Stenosis - · Deformities or curvatures (kyphosis, lordosis, or scoliosis) - Tumors - · Pseudoarthrosis - Failed Previous Fusion

Device Story

MVP Cervical Plate System; anterior cervical fixation device. Comprises plates and screws of various sizes; manual surgical instruments. Used by surgeons in clinical settings for spinal stabilization. Implants provide mechanical support to facilitate fusion in cervical spine (C2-C7). Principle of operation: rigid fixation via plate-screw construct. Benefits: stabilization of spinal segments to address degenerative, traumatic, or deformity-related conditions. Output: physical structural support. No software or AI components.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static compression, dynamic compression, and torsional testing per ASTM F1717-15. Reprocessing instruction validation performed. Results met acceptance criteria defined by predicate device performance.

Technological Characteristics

System includes plates, screws, and manual instruments. Implants: Ti6Al4V ELI titanium alloy (ASTM F 136), non-sterile, single-use. Instruments: Ti-6Al-4V or stainless steel, non-sterile, reusable. Mechanical fixation principle. No software, electronics, or energy sources.

Indications for Use

Indicated for skeletally mature patients requiring anterior cervical fixation (C2-C7) as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities (kyphosis, lordosis, scoliosis), tumors, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products. May 13, 2019 GS Medical Co., Ltd. % Ms. Manjusha Bharadwaj Senior Regulatory/Quality Consultant RQMIS, Inc. 110 Haverhill Road Amesbury, Massachusetts 01913 Re: K190170 Trade/Device Name: MVP Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: March 18, 2019 Received: March 20, 2019 Dear Ms. Bharadwaj: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/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. for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190170 Device Name MVP Cervical Plate System #### Indications for Use (Describe) The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: • Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - · Spondylolisthesis - · Trauma (including fracture or dislocation) - · Spinal Stenosis - · Deformities or curvatures (kyphosis, lordosis, or scoliosis) - Tumors - · Pseudoarthrosis - Failed Previous Fusion | 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 ## GS Medical MVP Cervical Plate System ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared GS Medical Co., Ltd. 90, Osongsaengmyeong 4-Ro Osong-Eup, Cheongwon-Gun, KR 363-951 Phone: 949-308-6385 Contact Person: Manjusha Bharadwaj Senior Regulatory/Quality Consultant RQMIS, Inc. 110 Haverhill Road Amesbury, MA 01913 Phone: 978-358-7307 Fax: 978-477-0206 Email: manjushabharadwaj@rqmis.com Date Prepared: January 11, 2019 #### Name of Device and Name/Address of Sponsor Trade Name: MVP Cervical Plate System GS Medical Co., Ltd. 90, Osongsaengmyeong 4-Ro Osong-Eup, Cheongwon-Gun, KR 363-951 #### Common or Usual Name Device Type: Anterior Cervical Plating System Classification Name: 21 CFR 888:3060 Spinal Intervertebral Body Fixation Orthosis Orthopedics, Product Code KWQ {4}------------------------------------------------ ## Reason for 510(k) Submission GS Medical is submitting this traditional 510(k) to gain clearance for the MVP Cervical Plate System. This device includes plates and screws of various sizes, as well as associated instruments. GS Medical believes that the MVP Cervical Plate System is substantially equivalent to the following: - . Synthes Anterior CSLP System (K030866) – primary - NUVASIVE HELIX MINI ACP SYSTEM (K073275) -- additional - . Depuy UNIPLATE 2 Anterior Cervical Plate System (K100070) - additional # Intended Use / Indications for Use The MVP Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: - . Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - . Trauma (including fracture or dislocation) - . Spinal stenosis - . Deformities or curvatures (kyphosis, lordosis, or scoliosis) - Tumors - Pseudoarthrosis - Failed previous fusion # Technological Characteristics The MVP Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The MVP Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136). The Instruments in the MVP Cervical Plate System are supplied non-sterile, are reusable, and are fabricated from titanium alloy Ti-6Al-4V or stainless steel. ## Performance Data Testing and analyses performed indicate that the MVP Cervical Plate System is as mechanically sound as the predicate device. Testing included static compression, dynamic compression, and torsional testing per ASTM F1717-15, as well as reprocessing instruction validation. The results demonstrate that the acceptance criteria defined by predicate device performance were met. ## Substantial Equivalence The intended use and technological characteristics (e.g., design, materials, principle of operations) of the MVP Cervical Plate System is substantially equivalent to the primary predicate Synthes Anterior CSLP System (K030866). Performance data demonstrates that the MVP Cervical Plate System is substantially equivalent to the Synthes Anterior CSLP System (K030866).
Innolitics
510(k) Summary
Decision Summary
Classification Order
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