| Libertas Hip Replacement System (K180973) | Maxx Orthopedics, Inc. | 2018-09-28 |
| Truliant Porous Femoral Components (K181794) | Exactech, Inc. | 2018-09-28 |
| ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (K181742) | Stryker GmbH | 2018-09-27 |
| Acculoc Total Knee System (K182370) | Rootloc Co., Ltd. | 2018-09-27 |
| CoLink View Plating System (K182402) | In2bones USA, LLC | 2018-09-27 |
| DualX (K181397) | Innovasive, Inc. | 2018-09-27 |
| CarboClear® Pedicle Screw System (K182377) | CarboFix Orthopedics , Ltd. | 2018-09-27 |
| Fixated Asfora BULLET CAGE® (FABC) (K181591) | Medical Designs, LLC | 2018-09-26 |
| OsseoScrew System (K181980) | Alphatec Spine, Inc. | 2018-09-25 |
| Comprehensive Reverse Shoulder System (K181611) | Biomet Manufacturing Corp | 2018-09-24 |
| REDAPT Porous Acetabular Shell (K181366) | Smith & Nephew, Inc. | 2018-09-24 |
| DePuy Corail AMT Hip Prosthesis (K173960) | Depuy France S.A.S. | 2018-09-21 |
| Arthrex FiberTak Suture Anchor (K181769) | Arthrex, Inc. | 2018-09-21 |
| Tranquil-L Interbody System (K181702) | Nexus Spine, LLC | 2018-09-21 |
| Chiral Surgical Pedicle Screw System (K181995) | Chiral Surgical | 2018-09-20 |
| MicroPort Orthopedics Total Hip Systems MR Labeling (K173898) | Microport Orthopedics Inc. (Mpo) | 2018-09-20 |
| Aequalis Flex Revive Shoulder System (K181420) | Tornier, Inc. | 2018-09-20 |
| FORTIFY Corpectomy Spacers (K173982) | Globus Medical, Inc. | 2018-09-19 |
| T2 STRATOSPHERE™ Expandable Corpectomy System (K181328) | Medtronic Sofamor Danek USA, Inc. | 2018-09-19 |
| TirboLOX-C Cervical IBFD (K181229) | Captiva Spine, Inc. | 2018-09-19 |
| Sypher Spacer System (K181337) | Biogennix, LLC | 2018-09-18 |
| Tandry Locking Plate System (K171904) | Microware Precision Co., Ltd. | 2018-09-18 |
| Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System (K181390) | OrthoPediatrics Corp. | 2018-09-18 |
| PALACOS MV (K182260) | Heraeus Medical GmbH | 2018-09-17 |
| Ceracell Ortho Foam (K181721) | Curasan AG | 2018-09-17 |
| Impress SFS System (K173910) | Cable Fix Medical, LLC | 2018-09-14 |
| Prime E-CLASS XLPE Liner (K181598) | Microport Orthopedics, Inc. | 2018-09-14 |
| DYNA-LINK ELITE Stand-Alone Anterior Lumbar System (K180215) | Life Spine, Inc. | 2018-09-13 |
| MOSS VRS Spinal System (K181821) | Biedermann Motech GmbH & Co. KG | 2018-09-13 |
| Sorrento Bioglass Bone Graft Substitute (K173933) | Xenco Medical, LLC | 2018-09-13 |
| BioSphere Flex (K173424) | Synergy Biomedical | 2018-09-12 |
| PRODENSE Bone Graft Substitute (K181255) | Wrightmedicaltechnologyinc | 2018-09-12 |
| LnK Lumbar Interbody Fusion Cage System (K181380) | L&K BIOMED Co., Ltd. | 2018-09-11 |
| Renovis S180 Lateral Lumbar Interbody Fusion System (K181655) | Renovis Surgical Technologies | 2018-09-11 |
| SECULOK™ ACP System (K182055) | U&I Corporation | 2018-09-10 |
| External Fixation System (K173883) | Life Spine, Inc. | 2018-09-07 |
| Corin Optimized Positioning System (OPS) Femoral (K181061) | Corin USA | 2018-09-07 |
| SILVERBACK Gorilla Plating System (K182148) | Paragon 28, Inc. | 2018-09-07 |
| Trabis (K173893) | Coligne AG | 2018-09-06 |
| Spinal Elements Cerclage System (K180728) | Spinal Elements, Inc. | 2018-09-06 |
| Exactech Alteon Monobloc Revision Stem (K181532) | Exactech, Inc. | 2018-09-04 |
| CarriGen PF (K182107) | Etex Corporation | 2018-08-31 |
| ALTAPORE (K181225) | Baxter Healthcare Corporation | 2018-08-31 |
| IlluminOss Bone Stabilization System (K181228) | Illuminoss Medical, Inc. | 2018-08-31 |
| Cure™ OPEL-C Plate System (K181543) | Meditech Spine, LLC | 2018-08-31 |
| SpineJack Expansion Kit (K181262) | Vexim SA | 2018-08-30 |
| Arthrex PushLock Tenodesis Anchor (K181513) | Arthrex, Inc. | 2018-08-30 |
| b-ONE® Total Hip System (K173380) | B-One Ortho, Corp. | 2018-08-30 |
| ACCUFUSE Cervical System (K181471) | Absolute Advantage Medical, LLC | 2018-08-29 |
| ResCUBE™ Ligament Fixation System (K181799) | Cousin Biotech Sas | 2018-08-29 |
| Genesys Spine AIS-C Cervical Stand-Alone System (K181295) | Genesys Spine | 2018-08-29 |
| CD HORIZON™ Spinal System (K182119) | Medtronic Sofamor Danek USA, Inc. | 2018-08-29 |
| REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (K172906) | Osteoremedies, LLC | 2018-08-29 |
| Tranquil Interbody System (K181483) | Nexus Spine, LLC | 2018-08-27 |
| Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw (K180179) | Orthofix, Inc. | 2018-08-24 |
| APTUS CMC-I Fusion Plate System (K181009) | Medartis AG | 2018-08-24 |
| NuVasive Brigade Lateral System (K181386) | Nu Vasive, Incorporated | 2018-08-24 |
| AOS Small Fragment Plating System Lite (K181035) | Advanced Orthopaedic Solutions, Inc. (Aos) | 2018-08-24 |
| Double Medical Femoral Nail System (K172830) | Double Medical Technology, Inc. | 2018-08-24 |
| CancelleX Porous Titanium Lumbar Interbody Device (K180373) | Xenco Medical, LLC | 2018-08-24 |
| GMK Sphere - Kinematic Alignment (K173890) | Medacta International S.A. | 2018-08-23 |
| GMK Sphere CR Tibial Inserts (K181635) | Medacta International S.A. | 2018-08-23 |
| ATEC Cervical Spacer System (K181435) | Alphatec Spine, Inc. | 2018-08-21 |
| MIDAScope and Introducer Kit, and MIDASystem (K181982) | Intravu, Inc. | 2018-08-21 |
| Actifuse Flow (K181306) | Baxter Healthcare Corporation | 2018-08-17 |
| Aries® Lumbar Interbodies (K181347) | Osseus Fusion Systems, LLC | 2018-08-15 |
| Duo™ Lumbar Interbody Fusion Device (K181792) | Spineology, Inc. | 2018-08-14 |
| Zenius™, Iliad™ and Kora™ Spinal Fixation Systems (K181978) | Medyssey USA, Inc. | 2018-08-13 |
| TirboLOX-L Lumbar IBFD (K180990) | Captiva Spine, Inc. | 2018-08-13 |
| Deformity Analysis and Correction Software (DACS) and Instrumentation (K180539) | Arrowhead Medical Device Technologies, LLC | 2018-08-13 |
| Redi-Spine (K181584) | Innovative Surgical Designs, Inc. | 2018-08-10 |
| CoreLink® M3™ Stand-Alone Anterior Lumbar System (K180814) | Corelink, LLC | 2018-08-10 |
| INFINITY Total Ankle System (K181557) | Wrightmedicaltechnologyinc | 2018-08-09 |
| MotoCLIP/HiMAX Step Staple Implant System (K181866) | Crossroads Extremity Systems, LLC | 2018-08-09 |
| Kodiak Spinal Fixation System (K181677) | Alphatec Spine, Inc. | 2018-08-09 |
| EVOS Wrist Fracture Plating System (K181533) | Smith & Nephew, Inc. | 2018-08-09 |
| ICONN Answer II Suture Anchor (K181680) | Iconn Orthopedics, LLC | 2018-08-09 |
| SECULOK™ Suture Anchor (K180759) | U&I Corporation | 2018-08-09 |
| EP Granules™ BVF (K180853) | Elute, Inc. | 2018-08-06 |
| Arthrex SwiveLock (K173845) | Arthrex, Inc. | 2018-08-06 |
| APTUS® Proximal Humerus System (K181425) | Medartis AG | 2018-08-05 |
| ASK System (K181146) | L and K Biomed Corporation Limited | 2018-08-03 |
| K2M Expandable Interbody System (K180777) | K2m, Inc. | 2018-08-03 |
| GRYPHON® Anchors with DYNACORD™ Suture (K181809) | Medos International SARL | 2018-08-03 |
| Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) (K181549) | Curiteva, LLC | 2018-08-03 |
| PL8 Wrist Reconstruction Plate (K180150) | Citieffe S.R.L. | 2018-08-02 |
| Curiteva Anterior Cervical Plate System (K181562) | Curiteva, LLC | 2018-08-02 |
| SuperCable® Iso-Elastic™ Cerclage System (K181749) | Kinamed, Incorporated | 2018-08-01 |
| Proficient® Posterior Cervical Spine System (K181440) | Spine Wave, Inc. | 2018-07-30 |
| Ti 3Z Interbody System (K180076) | Zavation Medical Products, LLC | 2018-07-27 |
| OIC Intramedullary Nail System (K181184) | The Orthopaedic Implant Company | 2018-07-27 |
| Stowe Pedicle Screw System (K181554) | Black Box Medical | 2018-07-27 |
| Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices (K180580) | Surgical Instrument Service and Savings, Inc. | 2018-07-27 |
| Corelink Foundation 3D Anterior Lumbar System (K180556) | Corelink, LLC | 2018-07-27 |
| Arthrex FibuLock Nail (K173656) | Arthrex, Inc. | 2018-07-26 |
| Republic Spine Dark Star Spinal System (K181495) | Republic Spine, LLC | 2018-07-25 |
| ATEC ALIF Spacer System (K181453) | Alphatec Spine, Inc. | 2018-07-25 |
| FIXIT / ComposiTCP Threaded Anchor System (K180960) | S.B.M. Sas Sciences For Bio Materials | 2018-07-25 |
| TREND II Spinal Fixation System- STEP Series (K180226) | Paonan Biotech Co., Ltd. | 2018-07-25 |
| Exactech Equinoxe Small Reverse Shoulder System (K180632) | Exactech, Inc. | 2018-07-25 |