UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

K100070 · Depuy Spine, Inc. · KWQ · Feb 4, 2010 · Orthopedic

Device Facts

Record IDK100070
Device NameUNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
ApplicantDepuy Spine, Inc.
Product CodeKWQ · Orthopedic
Decision DateFeb 4, 2010
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3060
Device ClassClass 2
AttributesTherapeutic

Intended Use

The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1. Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Device Story

UNIPLATE Anterior Cervical Plate System consists of titanium alloy plates and screws; used for anterior cervical intervertebral body fixation to provide stability following fusion; intended for levels C2-T1; operated by surgeons in clinical/OR settings; provides mechanical stabilization of cervical spine segments; benefits patient by maintaining alignment and facilitating fusion in cases of trauma, degeneration, or instability.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: ASTM F 136 implant grade titanium alloy. Form factor: Plates and screws for spinal fixation. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring anterior cervical intervertebral body fixation (levels C2-T1) for symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis/lordosis, tumor, degenerative disc disease, spinal stenosis, or re-operation for failed 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}------------------------------------------------ ## 5. 510(K) SUMMARY Submitter: DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767 FEB - 4 2010 Contact Person: Christopher Rogers Manager, Regulatory Affairs Voice: (508) 828-3224 Fax: (508) 828-3797 E-Mail: crogers4@its.jnj.com Date Prepared: January 8, 2010 Device Class: Class II Classification Name: Spinal intervertebral body fixation orthosis per 21 CFR §888.3060 Classification Panel: Orthopedics FDA Panel Number: 87 Product Code(s): KWQ Proprietary Name: UNIPLATE Anterior Cervical Plate System Predicate Devices: UNIPLATE Anterior Cervical Plate System (K042544) UNIPLATE Anterior Cervical Plate System (K082273) EAGLE Anterior Cervical Plate System (K040197) Device Description: The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws > The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification. - Intended Use: The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1. DePuy Spine, Inc., a Johnson & Johnson Company {1}------------------------------------------------ Special 510(k) Submission - Additions to UNIPLATE Anterior Cervical Plate System Indications include symptomatic cervical spondylosis. trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications. Manufactured from ASTM F 136 implant grade titanium Materials: alloy. Performance Data: Performance data were submitted to characterize the subject UNIPLATE Anterior Cervical Plate System components addressed in this notification. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized emblem, which is a modern interpretation of the Public Health Service (PHS) symbol, often referred to as the "Corps Device" or the "Caduceus." Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 DePuy Spine, Inc. % Mr. Christopher Rogers Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767 FEB - 4 2010 Re: K100070 Trade/Device Name: UNIPLATE Anterior 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 08, 2010 Received: January 11, 2010 Dear Mr. 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. 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 {3}------------------------------------------------ Page 2 - Mr. Christopher Rogers 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. Sincerely yours. Barbara Buettner Mark N. Me Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Special 510(k) Submission - Additions to UNIPLATE Anterior Cervical Plate System ## 4. INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Device Name: UNIPLATE Anterior Cervical Plate System Indications For Use: The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1. Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices K100070 510(k) Number_ DePuy Spine, Inc., a Johnson & Johnson Company Page 4-1
Innolitics
510(k) Summary
Decision Summary
Classification Order
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