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Timestamp: 2019-11-14 11:29:27
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Matched Legal Cases: ['§888', '§888', '§888', 'arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 807', 'art 803', 'art 21', 'art 21']

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510(K) SUMMARY A. Submitter Information DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767 Contact Person: Voice: Fax: E-Mail: B. C. Date Prepared Device Name Trade/Proprietary Name: Common/Usual Name: Classification Name: Moss® Miami and Expedium® Spine Systems Spinal System Spinal interlaminar fixation orthosis per 21 CFR §888.3050 Product code KWP Spinal intervertebral body fixation orthosis per 21 CFR §888.3060 Product code KWO Pedicle screw spinal fixation per 21 CFR §888.3070 Product code NKB3, MNI, MNH Classification D. Class Ill Kevin G. Stevens Regulatory Affa irs Project Manager (508) 977-6445 (508) 828-3797 [email protected] February 15, 2011
Predicate Device Name Trade name: DePuy Spine Expedium® Spine System (K033901) DePuy Spine Moss® Miami Spine System (K955348)
Device Description The Moss® Miami and Expedium® Spine Systems consists of rods, hooks, pedlicle screws, and other components. Asubset of the Moss Miami and Expedlium systems, which isthe basis of this submission, includes titanium pedlicle screws and rods that are now sterilized via gamma radiation. Previously, these devices were commercialized as clean, but non-sterile, and the end-user would need to sterilize the units prior to use via steam sterilization. Certain pedicle screws and rods will be packaged in sterile multi-packs for customer convenience.
Intended Use Moss® Miami System: The MOSS® MIAMI Spine System isa pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The MOSS® MIAMI Spine Systems isalso indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the [5-Si vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ([3 to sacrum) with removal of the implants after the attainment of a solid fusion. The MOSS® MIAMI Spine Systems isalso a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolist hesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The MOSS® MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis,
deformities (scoliosis, lordlosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). Expediumg Spine System: The EXPEDIUM® Spine System isintended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM® Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use The proposed devices are identical to the predicate devices except that the proposed devices will be terminally sterilized by DePuy Spine via gamma radiation. The gamma sterilization validation isperformed in compliance with ISO 11137:2006 (VD~MaX method). The design, materials, indications, and technology remain identical to the predicate systems. H. Materials manufactured from ASTMV F-136 implant grade titanium alloy. 1. Biocampatibility There have been no changes to the material as a result of the modification. Therefore no new biocompatibility testing has been submitted to support this submission.
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The Substantial Equivalence Justification demonstrates that the device isas safe, as effective, and performs as well as the predicate device
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Food and Drue Ad ministration 10903 New IHampshire Avenue Document Control Room -\V066-G609 Silver Spring, NitD 20993-0002
Johnson and Johnson % DePuy Spine, Inc. Mi.. Kevin 0. Stevens Regulatory Affahirs Project Manager 325 Paramount Drive Raynham, Massachusetts 02767 Re: K103490 Trade/Device Name: Moss Miami Spine System Expedium® Spine Systemn Regulation Number: 21 CER 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class Ill Product Code: NKB, MNH. MNI, KWP, KWQ Dated: January 14, 2011 Received: January 18, 2011 Dear Mr. Stevens:
We have reviewed your Section 5 10(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 11 (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 2 1, Parts 800 to 898: In addition, FDA may publish further announcements concerniing your device in the Federal Register.
Page 2 - Mr. Kevin G. Stevens 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 mustI 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 53 1-542 of the Act);, 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CER Part 801 ), please go to hittn://www. f'l~o/bLtD/etr~fcsCR/DHf1ie/ln 15809.hitr for the Center for Devices and Radiological Health's (CDRH-'s) Office of Compliance. Also, please note the regulation entitled, &quot;Misbranding by reference to premarket notification&quot; (2I1CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803)), please go to hitt6://www~fda.trov/MedicalDevices/Safety/ReportaProblem/defaulthtii for the CDRI-ls 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/ResouircesforYou/Industrv/defaultlitnm Sincerely yours,
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INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K103490 Device Name: Moss Miami Spine System
The MOSS MIAMI Spine System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The MOSS MIAMI Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The MOSS MIAMI Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordlosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The MOSS MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordlosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
Prescription Use _X__AND/OR (Part 21 CFR 801 Subpart D)
510(k)Nuniber
INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K103490
Device Name: Expediume Spine System
Indications For Use: The EXPEDIUM Spine System isintended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordlosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Prescription Use ___X -AN/OR (Part 21 CFR 801 Subpart D)
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