FDA Registration Active 🇺🇸 United States

MICROPORT ORTHOPEDICS INC.

Reg #: 3010536692 · FEI: 3010536692 · Expires 2026
Products
106
Proprietary Names
175
Establishment Types
7
Classifications
106

Registration Details

Registration Name
MICROPORT ORTHOPEDICS INC.
Registration Number
3010536692
FEI Number
3010536692
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
5677 AIRLINE RD
City
Arlington
State
TN
ZIP
38002
Country
US

Regulatory Submissions

510(k) Number
K926334
PMA Number
P030042

Owner / Operator

Firm Name
MicroPort Orthopedics Inc.
Operator Number
10045253
Address
5677 Airline Road
City
Arlington
State
TN
Postal Code
38002
Country
US
Correspondent
Ryan Ross

Products

Device Name Product Code
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Extractor HWB
Impactor HWA
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Kit, Surgical Instrument, Disposable KDD
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
Cap, Bone JDT
Lavage, Jet FQH
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Osteotome HWM
Saw HSO
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Osteotome, Manual GFI
Retractor, Fiberoptic FDG
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Prosthesis, Hip, Femoral, Resurfacing KXA
Awl HWJ
Forceps, Wire Holding HYA
Hook, Bone KIK
Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing NXT
Template HWT
Pusher, Socket HXO
Curette HTF
Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
Cement Obturator LZN
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
Bone Mill LYS
Trephine HWK
Splint, Hand, And Components ILH
Broach HTQ
Goniometer, Nonpowered KQW
Bur, Surgical, General & Plastic Surgery GFF
Wrench HXC
Twister, Wire HXS
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Screw, Fixation, Bone HWC
Starter, Bone Screw HWD
Hammer, Surgical FZY
Component, Traction, Non-Invasive KQZ
Retention Device, Suture KGS
Bender HXW
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented LPF
Clamp HXD
Reamer HTO
Mixer, Cement, For Clinical Use JDZ
Instrument, Manual, Surgical, General Use MDM
Instrument, Compression HWN
Applier, Cerclage HXN
Bit, Drill HTW
Punch, Femoral Neck HWP
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented MRA
Bone Cement LOD
Pin, Fixation, Threaded JDW
Blade, Saw, General & Plastic Surgery, Surgical GFA
Brace, Drill HXY
Burr, Orthopedic HTT
Passer HWQ
Caliper KTZ
Pliers, Surgical HTC
Chisel, Surgical, Manual FZO
Instrument, Cutting, Orthopedic HTZ
Rasp, Surgical, General & Plastic Surgery GAC
Tap, Bone HWX
Tamp HXG
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Probe HXB
Orthopedic Manual Surgical Instrument LXH
Elevator HTE
Knee Arthroplasty Implantation System OOG
Screwdriver HXX
Stripper, Surgical HRT
Knife, Orthopedic HTS
Driver, Prosthesis HWR
Passer, Wire, Orthopedic HXI
Rongeur HTX
Retractor GAD
Mallet HXL
Gauge, Depth HTJ
Ring Cutter FNS
Skid, Bone HWO
Rasp HTR
Prosthesis, Knee, Hinged (Metal-Metal) HRZ
Guide, Surgical, Instrument FZX
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
Spatula, Orthopedic HXR
Plate, Fixation, Bone HRS
Scissors, Orthopedic, Surgical HRR
Tray, Surgical, Instrument FSM
Tape, Measuring, Rulers And Calipers FTY
Cutter, Surgical FZT
Chisel, Bone, Surgical EML
Punch, Surgical LRY
Forceps HTD
Tracheotome LJW
Bit, Surgical GFG
Countersink HWW
File HTP

Proprietary Names

EXTRACTOR Impactor Bone Cap OSTEOTOME SAW Profemur Gladiator Cemented Classic Stem Powered Accessory osteotome Evolution retractor EVOLUTION® Hinge Knee System BIOLOX Delta Option Heads and Sleeves BIOLOX Delta Option XL Heads Awl Forceps ETIBCK00 - EVOLUTION® TIBIAL CEMENT KEEL Conserve Superpath Odyssey Template Pusher Bipolar Shell 18951018 ADVANTIM® POST STAB FEM LG LEFT NONPOROUS OPEN HOUSING Dynasty Additive Manufacturing Shells Prime Additive Manufacturing Shells E1204403 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 3 ES01TR13 EVOLUTION® KINEMATIC ALIGNMENT ICE INSTRUMENTATION TRAY 3 E1204404 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 4 E2102007 EVOLUTION® TIBIA EM MOUNTED STABILIZER E1503030 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 0MM ES01TR11 EVOLUTION® KINEMATIC ALIGNMENT ICE INSTRUMENTATION TRAY E1503024 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 4MM ES011040 EVOLUTION® KA CADDY CLASSIC GAP SPACERS E1503011 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 1MM E1503034 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 4MM E1503022 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 2MM E1503023 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 3MM ES00TR13 EVOLUTION® KINEMATIC ALIGNMENT INSTRUMENTATION TRAY 3 E1501010 EVOLUTION® KA IM DISTAL FEM ALIGNMENT GUIDE W/ ADJ PADS E1500030 EVOLUTION® KA EM ADJUSTABLE TIBIAL STYLUS E1503014 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 4MM E1503025 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 5MM ES011041 EVOLUTION® KA CADDY DISTAL REF GAP SPACERS E1501020 EVOLUTION® KA IM ADJUSTABLE VALGUS BUSHING E1503031 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 1MM EVOLUTION® Kinematic Alignment Instruments E1204405 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 5 ES01TR12 EVOLUTION® KINEMATIC ALIGNMENT ICE INSTRUMENTATION TRAY 2 E150012R EVOLUTION® KA EM TIBIAL SLOTTED SHIM RIGHT E110041R EVOLUTION® MA DCF POS REF FEM SIZING GUIDE RIGHT E1500050 EVOLUTION® KA UNIVERSAL THICKNESS CALIPER E110041L EVOLUTION® MA DCF POS REF FEM SIZING GUIDE LEFT E1500040 EVOLUTION® KA CARTILAGE THICKNESS GAUGE E2102008 EVOLUTION® TIBIA EM MOUNTED STABILIZER STRAP E1502040 EVOLUTION® KA OFFSET EM TIBIAL ROD W/ STOP E1503033 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 3MM E1500020 EVOLUTION® KA EM TIBIAL SHIM UNIVERSAL E1503013 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 3MM E1502030 EVOLUTION® KA STRAIGHT EM TIBIAL ROD W/ STOP E1503032 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 2MM E1500031 EVOLUTION® KA EM ADJUSTABLE TIBIAL STYLUS W/SPOONS E1503015 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 5MM E1503035 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 5MM E1204401 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK MONOLITHIC SIZE 1 E150012L EVOLUTION® KA EM TIBIAL SLOTTED SHIM LEFT E2102009 EVOLUTION® KA TIBIA EM ANKLE CLAMP ASSEMBLY E1204406 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 6 ES00TR11 EVOLUTION® KINEMATIC ALIGNMENT INSTRUMENTATION TRAY E1204407 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 7 E1500010 EVOLUTION® KA EM TIBIAL RESECTION GUIDE E1503012 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 2MM E1204402 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 2 ES00TR12 EVOLUTION® KINEMATIC ALIGNMENT INSTRUMENTATION TRAY 2 E1100431 EVOLUTION® MA SKI TIP STYLUS FOR AR & PR FEM SIZING GUIDE E1500060 EVOLUTION® KA RE-DRILL GUIDE SIZE 8 E1503021 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 1MM EVOLUTION® REV CONE INSERTER (E233CN01-06) EVOLUTION® REV SPACERS (E5101CN1-4) EVOLUTION® REV CONE TRIALS (E3500CN1-6) EVOLUTION® REV CONICAL BROACHES (E223CN01-06) EVOLUTION® REV CONE EXTRACTOR (E233CN11) EVOLUTION® REV CONICAL REAMERS (E2432CN01-06) EVOLUTION® TIBIAL CONES (ETKNCN01-06) EVOLUTION® REV BROACH ADAPTERS (E203CN01-03) EVOLUTION® REV REAMER PILOT (E2432CN11-13) EVOLUTION® REV CEMENT KEEL TRIAL (E3500CK1) Mill Trephine Splint Broach goniometer Bur Wrench Twister Nexus Hip Stem Prime Acetabular Cup System STARTER, BONE SCREW Hammer AXIOM® Second Generation Knee System Serrated Clip Suture Button Bender Procotyl Biolox clamp Reamer Advance Dynasty General Use Manual Instrument PROFEMUR® Preserve Sizes 1-3 Hip Stems Compression Instrument EVOLUTION REVISION CCK Applier, Cerclage BIT, DRILL Punch Profemur PROFEMUR® TL Classic Long Neck Hip Stems Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented EVOLUTION Stemmed CS Femur 18711131 STRYKER SAW BLADE 2000 NARROW STERILE 18711133 HALL 7 HOLE SAW BLADE NARROW 18711132 STRYKER SAW BLADE 2000 WIDE STERILE Brace, Drill Advantim Passer Caliper Pliers chisel Planar rasp PROCOTYL® L-O Acetabular System ADVANCE® Double High Insert Tap Tamp Probe Manual Surgical Instrument Elevator Profemur Preserve Classic REPIPHYSIS® Limb Salvage System Profemur Gladiator Thin HA Classic Stems with Collar Screwdriver Stripper PROFEMUR Renaissance Classic Long Neck Hip Stems KNIFE, ORTHOPEDIC Driver Passer, Wire PROFEMUR Z RONGEUR Mallet Depth Gauge ring cutter Skid RASP guide Spatula Scissors Interseal Perfecta Guardian Transcend Path Lineage tape, measuring Prosthesis, hip, semi-constrained (metal cemented acetabular component Cutter Chisel CANCELLOUS BONE SCREW MicroPort CoCr Femoral Heads saw blade Axiom Dynasty Dual Mobility System drill bit Countersink File EVOLUTION® BIOFOAM® Tibial System ADVANCE® BIOFOAM® Tibia

Establishment Types

Manufacture Device in the United States for Export Only Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Reprocess Single-Use Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198