510(k) Report

Devices descending from K051971

387 later devices reach Optima Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+1K193219G Surgical Marksman SystemG Surgical, LLC20191—
+1K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+1K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+1K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+1K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+1K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+1K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+1K110655Mahe Perfect Spine- Pedicle Screw SystemMahe Medical GmbH20110—
+1K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+1K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123—
+1K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+1K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+1K083077Ulc Spinal Pedicle Screw SystemOtis Biotech Co., Ltd.20090—
+1K071879Zimmer Dto ImplantZimmer Spine, Inc.200711
+1K063453Vertefix Pedicle Screw Spinal SystemElite Surgical Supplies (Pty), Ltd.20071—
+1K062513Apex Spine SystemSpinecraft, Inc.2006179—
+2K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+2K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+2K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+2K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+2K180324Patriot Spinal Fixation SystemValorus Spine20180—
+2K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+2K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+2K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+2K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+2K150417Astra Spine SystemSpinecraft, LLC201521—
+2K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+2K130655Response Spine SystemOrthoPediatrics Corp.201317—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121250OP Spine SystemOrthoPediatrics Corp.201218—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K110906Apex Spine SystemSpinecraft, LLC2011103—
+2K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+2K101704Zimmer Dto Pin Press InstrumentZimmer Spine, Inc.20100—
+2K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+2K080075Modification to: Vertefix Pedicle Screw Spinal SystemElite Surgical Supplies (Pty), Ltd.20080—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+3K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—