Omega LIF System

{0}------------------------------------------------ Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 10, 2015 Amendia, Incorporated Ms. Kristen Allen Senior Regulatory Consultant 1755 West Oak Parkway Marietta, Georgia 30062 Re: K150395 Trade/Device Name: Omega LIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 20, 2015 Received: July 21, 2015 Dear Ms. Allen: 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 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 {1}------------------------------------------------ Page 2 – Ms. Kristen Allen 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/Resourcesfor You/Industry/default.htm. 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 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 vours. Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150395 Device Name Omega LIF System #### Indications for Use (Describe) The Omega LIF device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Omega LIF implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | | Omega LIF<br>Á | | Submitter:Á | Œ ^} åæØ&ÆÁ<br>FÏ Í Í ÁY ĚJœÁÑæ\¸ œ Á<br>T åã caZOOZHEEI GÁ<br>Á | | Contact Person:Á | Sīāc^} ÁO^} Á<br>U¦ĚÁU^* ¦æ˜ ¦´ÁÔ[ } •˜ ¦œ} á<br>JFEŒÌ FŒÌ FÍ HÁÚD ΠΠΠGÊËFGFHÁCÒDÁ<br>\å\^} O æ{ ^} åãæ&{ ÁÇÆ ããDÁ | | Á<br>Date Prepared: | Œ *˘ • cÁ Ê´GÊFÍ Á | | Trade Name:Á<br>Á | U{ ^*æŠØÁÚ^•c^{ Á | | Common Name:<br>Á | Qe¦ç\c^¦c^¦à¦æ[ å˜ Á^•ã } Á^çã&^ | | Device Product Code<br>and Classification: | T ŒÝʌƽFÁO QÜÂ Ì Ì ÈHÌ €ÑÔ¦œ• Á¤Qe¦ç\c^¦c^¦à¦æ½Ó[ å˜ Áؘ•ã } Á<br>Ö^çã&^ÁÁ | | Primary Predicate Device:ÁÁ | Z^ˇ • ÁQe¦ç\c^¦c^¦à¦æ½Ø˜•ã } ÁÖ^çã&^•ÁS€Ì FÎ FI D | | Additional Predicate Devices: | I} c^*¦æÅ Ò¢] æ åæà\^Á Q¢¦ç^¦c^¦à¦æÁ ÓÍ å˜ Á ؘ•ã } Á<br>Ö^çã&^Á∞ÓÐÛÚ^•c^{ ÁSFHH FÌ DÁ | | Á | Ù¿d^\ ^¦ÂU] á ^ÁÒÐ&˜ ŠØ½Á/ŠÁę åÁÚŠÍÔæð ^ÁSFI FGFÏ DÁ | | Á | Qe¦ç\c^} cã } æå Á Új á ^Á U] cœæ ^Á Ò¢] æð åæà\^Á<br>Qe¦à[ å˜ Áؘ•ã } ÁÖ^çã&^ÁSFHHÍ Ì HDÁ | | Á | | | Device Description: | V@ÁJ{ ^* æŠØÁÚ^•c^{ Á Á§ Á§œÁ˜ ¦cã ¦ Á&[ { ] [ }^} á Á^•c^{ Á§[ { ] ¦ã^ãi Ác *¦È˜•^Á | ਕੋ | |ਕ੍ਰੇ ਟਰੰਡੀ AQ { } } } @ A = = ' ' } } @ A = = ' } = ' = ' } = ' = = ' ' ' ' = = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = ' = × • ^ a Á | | çã ^ Á d { æ: ¹^ Íæå¨ |○ Á¦^˘ ˘ãą * Áã ¢¹·ç¹·¢·à†æ¢àÍ âˆ Á· • ã } ÈÍV @ˆÁæ^Åâ^•ã } ^åÁç Á 8 } [ö } &ci } Á áigé ] ] |^{ ^} catal a celaireach } ( ^} catal } Bl A V@ÁU{ ^* æ͊ؽ • ° < { ´´´â´½ { } lã^³Å´ +ã } ^åÁí Á½ × ãƒ × âÁÍ Á ^ 戤® Á´ { `æÁÁ ] â ^Ê´ V @ ß ] |a c / x / x / x = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = ạ Á@ ã @ Ý C ất | ^ | æ = ^ | Á [ Á âx | Á x = + ] = ´ | * ã = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = න් දකු ද උප්රියාවේ පිහිටි විශ්ව ද දින දිස් ( ) ලි ( කිරි සිදු දි 1 කි කිබු ( • ˘] ^¦ã ¦Â±ã¸âÂ㸠^¦ã¡ ¡Â• `¦·æ· ·· ¡··· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ·· ^g] ˘│•ã﹜요 # Indications and Intended use: V@ ÁU{ ^* æ͊ؽâ^çã◊½ã½ã€ ãÁ£ ¹ ½ c^ ç^ ¡ c^ l c à¦æ •ム㠺 ã } Á ! [ 8 °ã ¹ ^ Áã Á •\ ^|^ထိ| Á{ æ '!^Á] æ Á ¸ ã@ â^* ^} ^|æ == Aãã ^æ ^ÁÇÖÖÖÍÅæÁ[] ^Á[ ¹Áç [ Á §[ } ã ° [ ° · Â ç ¹ ·  [ { Æ Í Ê Ï Ê Ö Ö Í å Í · 3 · å æ Á á 2 ° ~ ) æ á Á Á á Á Á Á Á {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Amendia" in blue font. The letter "A" is enclosed in a blue square. A grey line is located underneath the word. The Elements of Healing of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Omega LIF implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. # Summary of Technological Characteristics: The subject Omega LIF is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through comparison of characteristics including design, intended use, material composition, and function. Both the subject and predicate lumbar devices are straight, bullet-nosed interbody devices designed to contain graft material and facilitate fusion between two vertebral bodies in the lumbar region of the spine. # Summary of Performance Testing: Non-clinical mechanical testing for the Omega LIF system was performed on the worst case subject device. Testing included static and dynamic axial compression (ASTM F2077), Static and Dynamic Compression Shear (ASTM F2077), subsidence, expulsion, and wear testing. Performance testing demonstrated the Subject Device is substantially equivalent to the predicate device. # Conclusion: Based on the comparison to predicate devices and performance testing, the Omeqa LIF device has been shown to be substantially equivalent to leqally marketed predicate devices.