| RANGE/DENALI/MESA Spinal System (K153031) | K2m, Incorporated | 2015-11-17 |
| KYPHON XPEDE Bone Cement (K151227) | Medtronic | 2015-11-16 |
| EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base (K152298) | Microport Orthopedics, Inc. | 2015-11-16 |
| REDAPT Porous Acetabular Shell and Cemented Liner (K150790) | Smith & Nephew, Inc. | 2015-11-16 |
| Arthrex iBalance TKA System (K152252) | Arthrex, Inc. | 2015-11-16 |
| BoneCam Suture Anchors (K152255) | Valeris Medical | 2015-11-16 |
| Klassic Knee System (K153075) | Total Joint Orthopedics, Inc. | 2015-11-13 |
| SIGN Hip Construct (SHC) (K152757) | Sign Fracture Care International | 2015-11-13 |
| Polaris Spinal System (K151974) | Biomet Spine | 2015-11-13 |
| PIVOX(tm) Oblique Lateral Spinal System (K152277) | Medtronic Sofamor Danek USA, Inc. | 2015-11-13 |
| Humelock II Reversible Shoulder System (K150488) | Fx Solutions | 2015-11-13 |
| ATLANTIS Anterior Cervical Plate System (K152623) | Medtronic Sofamor Danek USA, Inc. | 2015-11-12 |
| Arthrex iBalance TKA System (K152382) | Arthrex, Inc. | 2015-11-12 |
| VLP Mini-Mod Talus Plates (K152976) | Smith & Nephew, Inc. | 2015-11-12 |
| FIBERGRAFT BG Morsels (K151154) | Prosidyan, Inc. | 2015-11-10 |
| Integrity Spine Lumbar Interbody Fusion System (K151819) | Integrity Spine Lumbar Interbody Fusion System | 2015-11-10 |
| EzFuze Implant System (K150211) | Vilex IN Tennessee, Inc. | 2015-11-10 |
| RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws (K152256) | Normed Medizin-Technik GmbH | 2015-11-05 |
| CD HORIZON Spinal System (K152248) | Medtronic Sofamor Danek USA, Inc. | 2015-11-05 |
| KATOR Suture Anchor (K152236) | Kator, LLC | 2015-11-04 |
| Talon DistalFix Antegrade/Retrograde Femoral Nail (K152295) | Orthopedic Designs North America, Inc. | 2015-11-03 |
| SternaLockĀ® 360 Sternal Closure System (K151019) | Biomet Microfixation | 2015-11-03 |
| FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control (K151992) | Zimmer, Inc. | 2015-11-02 |
| MasterLoc Stem (K151531) | Medacta International | 2015-10-30 |
| Acumed Ankle and Small Fragment Base Set Update (K151886) | Acumed, LLC | 2015-10-30 |
| Frontier Medical Devices In-line Orthopedic Cable Cerclage System (K151888) | Frontier Medical Devices, Inc. | 2015-10-30 |
| RECON system-V-TEK-IVP Plates and Screws (K152312) | Normed Medizin-Technik GmbH | 2015-10-30 |
| Physica PS Knee System (K152008) | Lima Corporate S.P.A. | 2015-10-29 |
| ARROW Humeral stems size 6 and 16 (K150568) | Fournitures Hospitalieres Industrie | 2015-10-29 |
| AVAmax Vertebral Balloon (K150523) | Care Fusion | 2015-10-29 |
| DSM Biomedical DPR Cable (K143716) | Dsm Biomedical | 2015-10-29 |
| Integra DigiFuse Cannulated Intramedullary Fusion System (K152527) | Ascension Orthopedics | 2015-10-29 |
| Small Bone Nail Implant (K151456) | Vilex IN Tennessee, Inc. | 2015-10-29 |
| iFuse Implant System (K151718) | SI-BONE, Inc. | 2015-10-29 |
| VERTEX(r) Reconstruction System (K152338) | Medtronic Sofamor Danek USA, Inc. | 2015-10-28 |
| JOURNEY II Uni Tibial Base and Insert (K152315) | Smith & Nephew, Inc. | 2015-10-28 |
| Genesys Spine TiLock2 Spinal System (K152039) | Genesys Spine | 2015-10-28 |
| Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts (K152169) | Ortho Development Corporation | 2015-10-27 |
| Genesis II XLPE Resurfacing Patellar Components (K150241) | Smith & Nephew, Inc. | 2015-10-27 |
| Acetabular Cup Orientation System (K150780) | Materialise NV | 2015-10-27 |
| Anchorage 2 CP System (K151769) | Stryker GmbH | 2015-10-27 |
| CD HORIZON Spinal System (K152457) | Medtronic Sofamor Danek USA, Inc. | 2015-10-27 |
| H-MAX S Femoral Hip System (K150855) | Lima Corporate S.P.A. | 2015-10-21 |
| iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System (K152704) | Conformis, Inc. | 2015-10-21 |
| NuVasive VuePoint II OCT System (K150474) | Nu Vasive, Incorporated | 2015-10-21 |
| S4 Cervical Spinal and Occiput Systems (K151938) | Aesculap Implant Systems, LLC | 2015-10-21 |
| JOURNEY II XR Knee System (K152726) | Smith & Nephew, Inc. | 2015-10-21 |
| Opticage Expandable Interbody Fusion Device (K152156) | Interventional Spine, Inc. | 2015-10-19 |
| Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System (K151648) | Altus Partners, LLC | 2015-10-16 |
| PASS OCT Spinal System (K150918) | Medicrea International SA | 2015-10-16 |
| HammerFiX Device (K152710) | Extremity Medical, LLC | 2015-10-15 |
| Amendia Cervical Plate System (K152455) | Amendia, Inc. | 2015-10-15 |
| OSS/Arcos IM Total Femur Rod (K152621) | Biomet, Inc. | 2015-10-14 |
| Dunamis Interference Screw (K151220) | Dunamis, LLC | 2015-10-14 |
| Px HA PEEK IBF System (K151785) | Innovasis, Inc. | 2015-10-14 |
| Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices (K150788) | Meditech Spine, LLC | 2015-10-14 |
| PHIN-FX Cannulated Lag Screw System (K150693) | Ascent Medical, LLC | 2015-10-13 |
| Endoskeleton TCS Interbody Fusion Device (K151596) | Titan Spine, LLC | 2015-10-09 |
| AttraX Putty (K151584) | Progentix Orthobiology BV | 2015-10-08 |
| CONCORDE Bullet Spinal System (K151352) | Medos International SARL | 2015-10-08 |
| STERISPINE PS (K151921) | Safe Orthopaedics | 2015-10-08 |
| Physica CR Knee System (K151266) | Lima Corporate S.P.A. | 2015-10-06 |
| Arcos One-piece Femoral Revision System (K151603) | Biomet, Inc. | 2015-10-06 |
| Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc (K150209) | Depuy Mitek, A Johnson and Johnson Company | 2015-10-06 |
| Inion Spinal Graft Containment System (K151360) | Inion OY | 2015-10-06 |
| STERISPINE PS (K151747) | Safe Orthopaedics | 2015-10-05 |
| Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) (K151500) | Custom Orthopaedic Solutions | 2015-10-05 |
| Valeo Spacer System and Valeo II Interbody Fusion Device System (K143518) | Amedica Corp. | 2015-10-02 |
| LOSPA IS Spinal System (K151408) | Corentec Co., Ltd. | 2015-10-02 |
| TiTHON Staple with OsseoTi Technology (K151615) | Biomet Manufacturing Corp | 2015-10-02 |
| Seneka I Polyscrew Pedicle Fixation System (K151849) | Senecka Spine | 2015-09-30 |
| GPC Intramedullary Nailing Systems (K143245) | Gpc Medical Limited | 2015-09-30 |
| Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 (K152171) | Orthofix Srl | 2015-09-28 |
| ARIX Ankle System (K152158) | Jeil Medical Corporation | 2015-09-28 |
| Bluefin Interbody System (K143479) | Tides Medical | 2015-09-25 |
| U2 Total Knee System- Additional Sizes (K150829) | United Orthopedic Corporation | 2015-09-25 |
| X-spine Pedicle Screw System (K152132) | X-Spine Systems, Inc. | 2015-09-25 |
| DePuy Actis Duofox Hip Prosthesis (K150862) | DePuy Orthopaedics, Inc. | 2015-09-25 |
| Renovis Anterior Cervical Plate System (K152193) | Renovis Surgical Technologies, Inc. | 2015-09-25 |
| U2 Femoral Component, CR, Porous Coated, Additional Sizes (K150832) | United Orthopedic Corporation | 2015-09-25 |
| NuVasive X-CORE Mini Cervical Expandable VBR System (K151651) | Nu Vasive, Incorporated | 2015-09-25 |
| Pyrenees Cervical Plate System (K152281) | K2m | 2015-09-24 |
| neon3 (K150650) | Ulrich GmbH & Co. KG | 2015-09-24 |
| Gemmed pedicle screw spinal system (K151592) | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 |
| Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (K151293) | Tornier S.A.S. | 2015-09-24 |
| Hedgehog Cervical Interbody Fusion Device (K143685) | Vertera, Inc. | 2015-09-23 |
| CrossRoads Screw System (K152072) | Crossroads Extremity Systems, LLC | 2015-09-23 |
| LDR Spine ROI-C Cervical Cage System (K150765) | Ldr Spine USA | 2015-09-17 |
| Everest Spinal System (K151727) | K2m, Inc. | 2015-09-17 |
| ODALYS Pedicle Screw System (K152098) | Kisco International | 2015-09-17 |
| Reliance Spinal Screw System (K152131) | Reliance Medical Systems, LLC | 2015-09-17 |
| RECON system - MPJ-Plates (K152142) | Normed Medizin-Technik GmbH | 2015-09-16 |
| Ackermann Intervertebral Body Fusion Device (K143450) | Ackermann Instrumente GmbH | 2015-09-16 |
| CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System (K150619) | Orthofix, Inc. | 2015-09-11 |
| Amendia Interbody Fusion Devices (K151322) | Amendia, Inc. | 2015-09-10 |
| Xenco Medical Cervical Interbody System (Argus) (K152302) | Xenco Medical, LLC | 2015-09-10 |
| Romeo posterior osteosynthesis system (K151695) | Spineart | 2015-09-10 |
| NuVasive CoRoent Lumbar System (K151472) | Nu Vasive, Incorporated | 2015-09-10 |
| TGM Biolox delta Ceramic Heads (K150576) | Tgm Medical, Inc. | 2015-09-09 |
| SECURE-LOOP (K151601) | Xiros, Ltd. | 2015-09-09 |