ARCHIMED REMEDY CERVICAL PLATE

K100215 · Archimed, Inc. · KWQ · Apr 7, 2010 · Orthopedic

Device Facts

Record IDK100215
Device NameARCHIMED REMEDY CERVICAL PLATE
ApplicantArchimed, Inc.
Product CodeKWQ · Orthopedic
Decision DateApr 7, 2010
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3060
Device ClassClass 2
AttributesTherapeutic

Intended Use

The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4) Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failed previous fusions. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

REMEDY Cervical Plate System consists of titanium alloy (ASTM F136) bone plates, screws, and associated surgical instruments. Used by surgeons via anterior approach to provide temporary fixation to cervical spine (C2-T1) during fusion procedures. Device provides mechanical stabilization to vertebral bodies. Output is physical fixation of spinal segments. Benefits include stabilization of spine to facilitate fusion in patients with degenerative, traumatic, or deformity-related conditions.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static axial compression bending, dynamic axial compression bending, and static torsion tests per ASTM F1717.

Technological Characteristics

Titanium alloy (ASTM F136) bone plates and screws. Mechanical fixation via anterior approach. Dimensions and screw angulation designed for cervical spine anatomy. No software or electronic components.

Indications for Use

Indicated for temporary anterior spinal stabilization during cervical fusion (C2-T1) in patients with degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, or failed previous fusions. Contraindicated for posterior element (pedicle) attachment.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ ## REMEDY™ Cervical Plate System 510(K) SUMMARY | Submitter | ArchiMed Inc.<br>50 W 3rd Ave<br>Collegeville, PA 19426<br>(800) 991-4559 | Date: | April 7, 2010 | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------| | | | Contact: | Barry Aiken<br>ArchiMed Inc<br>50 W 3rd Ave<br>Collegeville, PA 19426 | | Trade Name | REMEDY™ Cervical Plate System | | | | Common Name | Cervical Plating Instrumentation | APR - 7 2010 | | | Classification | KWQ – 888.3060<br>Class II, Spinal Intervertebral Body Orthosis | | | | Device Description | The Remedy Cervical Plate System consists of a variety of shapes and sizes of bone plates,<br>screws, and associated instruments. Fixation is provided by bone screws inserted into the<br>vertebral body of the cervical spine using an anterior approach. The REMEDY Cervical<br>Plate System implant components are made from titanium alloy described by ASTM F136. | | | | Indications for Use | The REMEDY Cervical Plate System is intended for anterior interbody screw/plate fixation<br>from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior<br>spine during the development of cervical spinal fusions in patients with: 1) Degenerative Disc<br>Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed<br>by patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4)<br>Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failed<br>previous fusions. | | | | | WARNING: This device is not intended for screw attachment to the posterior elements<br>(pedicles) of the cervical, thoracic, or lumbar spine. | | | | Non-Clinical Tests | Static Axial Compression Bending, Dynamic Axial Compression Bending, and Static Torsion<br>Tests per ASTM F1717 demonstrate the REMEDY Cervical Plate System is substantially<br>equivalent to the predicate devices. | | | | Predicate Devices | The REMEDY Cervical Plate System has identical indications for use, material, and employs<br>the same principles of operation as predicate devices. Furthermore, its prominence on the<br>spine, range of sizes, and screw angulation are at or within the limits of the predicate devices.<br>Based on these factors, the REMEDY Cervical Plate System is Substantially Equivalent to<br>the predicate devices. | | | | | Device | Company | 510(k) Number | | | Atlantis Vision | Medtronic | K021461 | | | Venture | Medtronic | K042922 | | | Premeir | Medtronic | K992110 | | | Zephir | Medtronic | K030327 | | | Skyline | Depuy | K052552 | | | Uniplate | Depuy | K042544 | | | Swift | Depuy | K040655 | | | Reflex Hybrid | Stryker Spine | K040261 | | | Trinica Select | Zimmer | K022344 | | | Providence | Globus | K070775 | Vectra-T Pyrenees Helix ACP Gradient Plus CSLP K030866 K000536 K060442 K071329 K023281 Synthes Spine Synthes Spine : 彩 K2M Nuvasive Nuvasive {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a sans-serif font and is black. To the left of the text is a symbol that appears to be three curved lines. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 ArchiMed, Inc. % Mr. Barry Aiken Chief Financial Officer 50 West 3rd Avenue Collegeville, Pennsylvania 19426 APR - 7 2010 Re: K100215 Trade/Device Name: REMEDY™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 19, 2010 Received: January 25, 2010 Dear Mr. Aiken: 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 {2}------------------------------------------------ Page 2 - Mr. Barry Aiken 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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. Singerely yours. Mark N. Melkersor Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT | 510(k) Number: | K100215 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | REMEDY™ Cervical Plate System | | Indications for Use: | The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: | | | 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), | | | 2) Trauma (including fractures), | | | 3) Tumors, | | | 4) Deformity (defined as kyphosis, lordosis, or scoliosis), | | | 5) Pseudarthrosis, and/or | | | 6) Failed previous fusions. | | | Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine. | X Prescription Use (Part 21 CFR 801 Subpart D) . AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices KIDOZIS 510(k) Number_
Innolitics
510(k) Summary
Decision Summary
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