BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PARAGON MEDICAL, INC.

    Reg #: 1834331 · FEI: 1000306340 · Expires 2026
    View on FDA
    Products
    114
    Proprietary Names
    292
    Establishment Types
    2
    Classifications
    114

    Registration Details

    Registration Name
    PARAGON MEDICAL, INC.
    Registration Number
    1834331
    FEI Number
    1000306340
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8 Matchett Dr.
    City
    PIERCETON
    State
    IN
    ZIP
    46562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152951

    Owner / Operator

    Firm Name
    Paragon Medical
    Operator Number
    9011072
    Address
    8 Matchett Dr., --
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    Stephane Langlois

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Rod, Fixation, Intramedullary And Accessories HSB
    Prosthesis, Elbow, Constrained, Cemented JDC
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Reamer HTO
    Bone Mill LYS
    Broach HTQ
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI
    Plate, Fixation, Bone HRS
    Saw, Pneumatically Powered KFK
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Screw, Fixation, Bone HWC
    Pin, Fixation, Smooth, Metallic NDL
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL
    Wrench HXC
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Spinal Vertebral Body Replacement Device MQP
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Thoracolumbosacral Pedicle Screw System NKB
    Nail, Fixation, Bone JDS
    Tamp HXG
    Bit, Drill HTW
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Cerclage, Fixation JDQ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Accessories, Implant, Dental, Endosseous NDP
    Driver, Prosthesis HWR
    Pin, Fixation, Smooth HTY
    Prosthesis, Wrist, Hemi-, Ulnar KXE
    Awl HWJ
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Shoulder Prosthesis, Reverse Configuration PHX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Extractor HWB
    Tray, Surgical, Ent MMO
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Retractor, Self-Retaining, For Neurosurgery GZT
    Orthopedic Manual Surgical Instrument LXH
    Guide, Surgical, Instrument FZX
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Semi-Constrained Metal/Polymer Finger Joint Prosthesis MPK
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Clamp HXD
    Plate, Bone, Growth Control, Pediatric, Epiphysiodesis OBT
    Accessories, Arthroscopic NBH
    Rasp HTR
    Tap, Bone HWX
    Motor, Surgical Instrument, Ac-Powered GEY
    Prosthesis, Finger, Constrained, Metal/Polymer KWG
    Motor, Drill, Electric HBC
    Instrument, Bending Or Contouring HXP
    Gauge, Depth HTJ
    Cutter, Surgical FZT
    Template HWT
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Bone Cement, Posterior Screw Augmentation PML
    Tray, Surgical LRP
    Prosthesis, Finger, Constrained, Polymer KYJ
    Neurological Stereotaxic Instrument HAW
    Instruments Designed For Press-Fit Osteochondral Implants QBO
    Instrument, Manual, Surgical, General Use MDM
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Arthroscope HRX
    Motor, Drill, Pneumatic HBB
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing NXT
    Instrument, Cutting, Orthopedic HTZ
    Punch, Surgical LRY
    Software For Diagnosis/Treatment OSN
    Osteotome HWM
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Prosthesis, Intervertebral Disc MJO
    Retractor GAD
    Impactor HWA
    Tray, Surgical, Instrument FSM
    Apparatus, Traction, Non-Powered HST
    System, Image Processing, Radiological LLZ
    Screwdriver HXX
    Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer KRQ
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Instrument, Ent Manual Surgical LRC

    Proprietary Names

    GALAXY WRIST TRAY EMPTY TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER ANKLE HINDFOOT NAILING SYSTEM - INSERTION INSTRUMENTS CASE EMPTY ANKLE HINDFOOT NAILING SYSTEM - DRILLS AND REAMERS CASE EMPTY ANKLE HINDFOOT NAILING SYSTEM - EXTRACTION INSTRUMENTS CASE EMPTY Zimmer Nexel Total Elbow REAMER DEPTH STOP 10/12MM GENESIS The GIRO Growth Modulation System Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) REAMER DEPTH STOP 8/10MM Z1 Hip System A.L.P.S. Clavicle Plating System Clavicle Plating Instruments ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology Camera Sterilization Tray Set Endoscope and Camera Sterilization Tray Set Advanced Imaging Modality (AIM) Sterilization Tray Set Sonopet iQ Sterilization Tray Comp. Primary Broach Cover Set TRUELOK TRAUMA - INSTRUMENTS CASE, US TRUELOK TRAUMA CASE, US TriALTIS Spine System Zimmer Biomet Fluted Pin Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit) Universal Pin SYNERGY Comprehensive Shoulder System Driver STERILIZATION BOX EMPTY EXPEDIUM VERSE DRIVER - SLEEVE TriALTIS Navigation Enabled Instruments Comprehensive SRS Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented. Shoulder Prosthesis, Reverse Configuration Comprehensive Revision Broach/Provisional 12mm Comprehensive Revision Broach/Provisional 8mm Comprehensive Revision Broach/Provisional 14mm Comprehensive Revision Broach/Provisional 6mm Comprehensive Revision Broach/Provisional 10mm Comprehensive Revision Broach/Provisional 4mm Zimmer Persona Personalized Knee System PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER Persona® The Personalized Knee System Persona Revision Knee System TRIGEN POLYETHYLENE LINER EXTRACTOR DRIVE SHAFT TRABECULAR METAL REVISION SHELL LINERS Drill Sleeve Insert K-Wire Sleeve Insert Orthopedic Manual Surgical Instrument LITe Funnel Bone Tap Freehand Drill IMN Instruments ø4.2x185mm Locking Drill IMN Instruments ø4.2x360mm Trocar SPS-MonoAxial Locking Set 5mm Inserter sleeve Freehand Drill IMN Instruments ø3.5x130mm Drill Sleeve D4.3 "Insertion Sleeve for ø3.2mm Guide Wires" Depth Gauge 0-120mm Insert ø3.2 compression Guide Wire D3xL300 Trocar SPS-MonoAxial Locking Set 4mm Freehand Drill IMN Instruments ø3.5x185mm Drill Guide ø6.55 Drilling Guide ø3.2/4.5 Locking Drill IMN Instruments ø3.5x360mm Depth Gauge 0-70mm for Screws: ø2.7/3.5/4mm Freehand Drill IMN Instruments ø4.2x130mm Insert ø2.5 compression Tissue prot. sleeve ø6.5/4.5 Threaded Guide Wire D3.2xL300 (Sterile) Screw Insertion Sleeve ø9mm Lag Screw Tap Sleeve Drilling Guide ø2.5/3.5 Parallel Drill Guide Insert ø2.5 neutral Drill Sleeve Handle Direct Measuring Gauge Depth Gauge 0-150mm for Screws: ø4.5/6.5mm Drill Guide Supracondylar Lag Screw Depth Gauge Drill Sleeve D3.1 Depth Gauge 0-110mm For Screws ø2.7/3.5/4 Depth Gauge 0-150mm for Screws: ø2.7/3.5/4mm Insert ø2.5 support Drilling Guide ø2/2.7 Drill Gauge (Percutaneous) Guide Wire D3.2xL300 Threaded Guide Wire D3.2xL300 Guide Wire with Ruler Tube Insert ø3.2 neutral Guide Wire D3.2xL300 (Sterile) Distractor Twist Drill Centerpiece Plate Fixation System C-STEM AMT SZ 3A NK SEGMENT IMN™ Instruments C-STEM AMT STD NECK SEGMENT- SZ0/1 INSERTION SHIM - HANDLE Guide Wire C-STEM AMT SZ 2A NK SEGMENT C-STEM AMT HO NECK SEGMENT- SZ4/5 C-STEM AMT HO NECK SEGMENT- SZ 0/1 C-STEM AMT HO NECK SEGMENT- SZ2/3 C-STEM AMT STD NECK SEGMENT- SZ2/3 C-STEM AMT STD NECK SEGMENT- SZ6/7 AMBI Robotic Integration Instruments Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Tornier HRS Max Two Level Rack Stryker Universal Select Sterilization Tray System EXTENDED PLUS LINE CADDY EMPTY QUAD PLATE PLUS CADDY EMPTY EIGHT PLATE PLUS CADDY EMPTY Graft Sizer SharpShooter Cannula Right Middle SharpShooter Cannula Right Posterior CMI Delivery Clamp CMI Measuring Cannula SharpShooter Cannula Left Middle SharpShooter Cannula Right Anterior SharpShooter Cannula Left Anterior SharpShooter Cannula Left Posterior Intermediate Tap, Locking, AO 2 FRAGMENT PLATE BENDER END 2 FRAGMENT PLATE BENDER Depth Gage SYMPHONY INSTRUMENT GRAPHIC CASE KEEL TIB PUNCH GUIDE SZ1.5-4 TriALTIS™ Spine System 36MM POLY LINER PLUS 3MM OFS C-STEM AMT BROACH SIZE 3 C-STEM AMT BROACH SIZE 2 C-STEM AMT BROACH SIZE 1A C-STEM AMT BROACH SIZE 3A C-STEM AMT BROACH SIZE 1 C-STEM AMT BROACH SIZE 2A C-STEM AMT BROACH SIZE 8 C-STEM AMT BROACH SIZE 5 C-STEM AMT BROACH SIZE 7 C-STEM AMT BROACH SIZE 4 AGILE NAIL STERILIZATION BOX EMPTY AGILE NAIL STERILIZATION BOX EXTRACTION EMPTY Persona® The Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES LEGION TRAUMA TRAY, TL-HEX, EMPTY Instrument tray, for semi-rigid ureteroscope Zmimbmlyer Trabecular Metal Total Ankle CHIMAERA INSTRUMENT TRAY, EMPTY CHIMAERA INSTRUMENT TRAY EXTRA EMPTY EXTRACTION INSTRUMENT TRAY EMPTY PERI-LOC Drill Bit, AO Triathlon Primary & MIS Patella Preparation Caddy Triathlon MIS Femoral Preparation Tray TS Femoral Augments Trials Tray TRIATHLON REVISION INSTRUMENTS FEMORAL CONE PREP 1 TRAY Journey II Restoration Modular Conical Distal Reamers Tray (10mm-17mm) TS TCG Insert Trials (Size 1-5, 22-31mm) Tray RESTORATION MODULAR CONICAL DISTAL STEM TRIALS TRAY 115MM HINGE FEMORAL TRIALS - LEFT TRAY Restoration Modular Conical Distal Reamers Tray (18mm-23mm) Triathlon Pro Miscellaneous Instruments Tray HINGE TCG TRAY Revision Finishing Tray TS Misc. Instruments Tray TRIATHLON REVISION INSTRUMENTS TIBIAL CONE UPPER TRAY TRIDENT TRITANIUM INSERT TRIALS TRAY Hinge Insert Trials Tray TS Insert Trials (9-19mm) Tray Revision Tibial Prep Tray Revision IM Reamers (20-25mm) Tray FEMORAL AUGMENT TRIALS AND DISTAL SPACERS CADDY Triathlon 5511 PS Femoral Trials Tray - Left TS Femoral Trials - Left Tray Trident II Reamers (38-66mm) Tray TS Femoral Trials - Right Tray TRIATHLON PRO PS BOX REAM PREPARATION TRAY Triathlon Pro PS Insert Trials Tray (Size 0-7) Femoral Distal Spacers Caddy REVISION BASEPLATE FINISHING TRAY Triathlon Primary & MIS Patella Preparation Tray TS Universal Baseplate Finishing Tray TRIATHLON PRO MISCELLANEOUS INSTRUMENTS TRAY WITH CR PATELLA TRACK TRIALS Femoral Distal Augment Trials (Size 1-4) Caddy Offset Reamer Handle Tray Trident Tritanium Window Trials Tray Accolade II Broach Tray Accolade II Basic Tray Trident II Core Reamers (38-66mm) Tray Acetabular Reamers (67-80)mm Tray Trident Window Trials Tray Tritanium Window Trials Tray Trident II Auxiliary Trials Tray Acetabular Reamers (36-66)mm Tray Trident Constrained Insert Trials Tray Trident II General Instruments Tray Exeter Retractor Tray Trident II Core Trials Tray Modular Dual Mobility Tray MIS TKA IM LID General Femoral Tray LCCK ART SURFACE PROV CASE LCCK STEM PROV BASE, FLUTED ELEOS™ INSTRUMENTATION TRAY, TRAY LID STANDARD ELEOS™ INSTRUMENTATION TRAY, MALE-MALE MIDSECTION TRIALS, TRAY 12 LCCK STEM PROV CASE, STR/OFS Exeter Broach Tray ELEOS™ INSTRUMENTATION TRAY, RESURFACING STEM TRIALS, TRAY 5 ELEOS™ INSTRUMENTATION TRAY, PATELLA INSTRUMENTS, TRAY 10 Exeter Extension Broach Tray ELEOS™ INSTRUMENTATION TRAY, FEMORAL RESURFACING INSTRUMENTS, TRAY 9 Exeter Plug Trial Tray Triathlon Tritanium Central Femoral Cone Preparation Tray ELEOS™ INSTRUMENTATION TRAY, GENERAL RESURFACING INSTRUMENTS, TRAY 8 ELEOS™ INSTRUMENTATION TRAY, TIBIAL RESURFACING TRIALS, TRAY 6 LCCK BLOCK AUGMENT PROV BASE WalterLorenz Surgical Assist Arm ELEOS™ INSTRUMENTATION TRAY, AUGMENT PREPARATION AND TRIALING INSTRUMENTS, TRAY 13 ELEOS™ INSTRUMENTATION TRAY, PROXIMAL TIBIA TRIALS, TRAY 11 LCCK FEM AUG & BOX PROV TRAY Tray, Surgical, Instrument LCCK FEM CUTTING INST CASE ELEOS™ INSTRUMENTATION TRAY, PIN CADDY, KIT TO TRAY 8 GENERIC STACKABLE LID ASSY LCCK REAMER BASE W/ T-HANDLE ELEOS™ INSTRUMENTATION TRAY, SEGMENTAL STEM TRIALS, TRAY 3 NEXGEN FEM RESECT BASE ASSY ELEOS™ INSTRUMENTATION TRAY, PROXIMAL DISTAL FEMORAL SEGMENTAL TRIALS, TRAY 4 ELEOS™ INSTRUMENTATION TRAY, REAMERS, TRAY 1 ELEOS™ INSTRUMENTATION TRAY, TIBIAL RESURFACING PREPARATION INSTRUMENTS, TRAY 7 ELEOS™ INSTRUMENTATION TRAY, ASSEMBLY/DISASSEMBLY INSTRUMENTS, TRAY 2 ELEOS™ INSTRUMENTATION TRAY, TRAY LID SMALL STERILIZATION TRAY TIB TM CONE VPC Instruments STERILIZATION BASE TIB TM CONE VIPER PRIME CFXFEN XTAB TRAY 2 Persona Modular Case Component Persona Modular Case Componet PRIMARY DELIVERY SYS VIPER PRIME SCREW CADDY VIPER PRIME CFXFEN X-TAB TRAY SR LID BASE ASSEMBLY BASE Restoration Modular Conical Distal Reamers Tray (24mm-28mm) Triathlon Pro 4IN1's & Spacer Blocks Tray Triathlon Pro Patella Preparation Caddy HINGE FEMORAL PREP TRAY SR LID BASE ASSEMBLY LID PRIME TOP IMPLANT TRAY Triathlon Pro Femoral Trials Tray - Right Triathlon Pro CS Insert Trials Tray (Size 0-7) TS TCG Insert Trials (Size 6-8, 22-31mm) Tray TRIATHLON INSERT TRIAL TRAY-CS(SIZE 1-8) TRIATHLON INSERT TRIAL TRAY-CR(SIZE 1-8) TS Insert Trials (size 1-5, 22-31mm) Tray TRIATHLON REVISION INSTRUMENTS FEMORAL CONE PREP 2 TRAY Universal Lid Triathlon Primary/Express/MIS Tibial Preparation Tray Revision General Tray HINGE FEMORAL TRIALS - RIGHT TRAY Femoral Posterior Augment Trials (Size 1-8) Caddy Revision IM Reamers (8-19mm) Tray Femoral Distal Augment Trials (Size 5-8) Caddy Triathlon PS Box Cutting Guides Tray TS Femoral Prep Tray Triathlon Pro Femoral Trials Tray - Left Triathlon Pro CR Insert Trials Tray (Size 0-7) Revision 100mm Stem Trials (9-25mm) Tray Revision 150mm Stem Trials (9-25mm) Tray Offset Adapter Trials Caddy ETS Instrument Tray Triathlon Pro Miscellaneous Instruments Caddy RESTORATION MODULAR GENERAL INSTRUMENTS TRAY TS Insert Trials (size 6-8, 22-31mm) Tray TRIATHLON REVISION INSTRUMENTS TIBIAL CONE LOWER TRAY Restoration Modular Proximal Cone Reamers Tray (19mm-31mm) Triathlon Pro Tibial Preparation Tray Restoration Modular Auxiliary Instruments Tray TS TCG Tray Restoration Modular Conical Distal Stem Trials Tray 155mm Triathlon Pro Patella Preparation Tray Triathlon Primary & Express Femoral Preparation Tray Restoration Modular Extraction Instruments Tray TS TCG Insert Trials (9-19mm) Tray TRIATHLON INSERT TRIAL TRAY-PS(SIZE 1-8) Triathlon 5511 PS Femoral Trials Tray - Right Insignia Instrumentation Screwdriver

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device