FDA Registration Active 🇺🇸 United States

TOTAL JOINT ORTHOPEDICS, INC.

Reg #: 3008544874 · FEI: 3008544874 · Expires 2026
Products
21
Proprietary Names
340
Establishment Types
2
Classifications
21

Registration Details

Registration Name
TOTAL JOINT ORTHOPEDICS, INC.
Registration Number
3008544874
FEI Number
3008544874
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1567 E. Stratford Avenue
City
Salt Lake City
State
UT
ZIP
84106
Country
US

Regulatory Submissions

510(k) Number
K161073

Owner / Operator

Firm Name
Total Joint Orthopedics, Inc
Operator Number
10036774
Address
1567 E. Stratford Avenue
City
Salt Lake City
State
UT
Postal Code
84106
Country
US
Correspondent
Brendan Perkins

Products

Device Name Product Code
Corkscrew HWI
Extractor HWB
Wrench HXC
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Template HWT
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Screwdriver HXX
Orthopedic Manual Surgical Instrument LXH
Impactor HWA
Orthopedic Tray OJH
Reamer HTO
Trephine HWK
Bit, Drill HTW
Broach HTQ

Proprietary Names

Femoral Head Remover, Corkscrew Cone Extractor BiPolar Head Extractor Femoral Stem Extractor Hoop Modular Slap Hammer Extractor Impactor Offset Femoral Stem Trial Extractor Femoral Stem Adapter Wrench Spline Wrench Handle Cover Spline Wrench Handle Spline Wrench, Closed Spline Wrench Klassic HD Acetabular Inserts with XLPE Klassic Femur with Aurum Klassic® All-Poly Tibias, Ultra-PS®, Std Poly Klassic® All-Poly Tibia, CR/Congruent, Std Poly BIOLOX OPTION Femoral Heads Adapters for BIOLOX OPTION Femoral Heads BIOLOX delta Femoral Heads Klassic Tibial Insert, Ultra-PS, E-Link Poly Klassic Domed Patella with E-Link Klassic Sombrero Patella with E-LInk Klassic Tibial Insert, CR/Congruent, E-Link Poly Klassic Knee Tibial Insert, PS-Post, Std Poly Klassic Knee Femur, PS-Post Klassic Knee Femoral Peg Klassic Knee Tibial Insert, PS-Post, E-Link Poly Klassic Blade Femoral Stems, Sizes 10-12 Klassic Blade Offest Femoral Stems, Sizes 10-12 Klassic Knee Templates, Stem Extensions Acetabular X-Ray Templates Klassic Knee Templates, PS-Max BiPolar X-Ray Template Set Platform Cup X-ray Template Femoral X-Ray Templates Klassic Knee Template, Tibial Baseplate, Revision Cone X-Ray Template Offset Femoral Stem X-Ray Templates BIOLOX CONTOURA Ceramic Femoral Head Klassic Tibial Insert, CR/Congruent, Std Poly, sizes 1-6, 18mm Klassic Tibial Insert, Ultra-PS, Std Poly, Sizes 1-6, 18mm Klassic HD Low Profile Acetabular Insert with E-Link Poly Klassic HD Hooded Acetabular Insert with E-Link Poly Klassic BiPolar 22mm Femoral Head Klassic BiPolar Head Klassic BiPolar 28mm Femoral Head Klassic HD Acetabular Insert with E-Link Poly, 28mm head Klassic HD Hooded Acetabular Insert with E-Link Poly, 28mm head Klassic HD Acetabular Cup with Ti-Coat, 44mm Klassic HD Low Profile Acetabular Insert with E-Link Poly, 22mm head Klassic HD Hooded Acetabular Insert with XLPE 28mm BIOLOX delta Ceramic Femoral Head Klassic HD Low Profile Acetabular Insert with XLPE Klassic HD Acetabular Insert with E-Link Poly, 22mm head Klassic HD Acetabular Insert with XLPE, 22mm head Klassic HD Low Profile Acetabular Insert with E-Link Poly, 28mm head Klassic HD Acetabular Insert with XLPE, 28mm head 22mm BIOLOX delta Ceramic Femoral Head Klassic HD Acetabular Cup with Ti-Coat, 46mm Klassic HD Hooded Acetabular Insert with E-Link Poly, 22mm head 28mm BIOLOX OPTION Femoral Head, 16/18 taper Acetabular U-Joint Screwdriver 3.5mm Hex Screwdriver, Klassic ONE 3.5mm Hex Screwdriver – Metal Handle 3.5mm Hex Screwdriver Klassic Tibial Insert, PS-Post, Std Poly Klassic All-Poly Tibia, PS-Post, Std Poly Klassic All Poly Tibia, PS-Post, E-Link Poly Klassic Tibial Insert, PS-Post, E-Link Poly Klassic Sombrero Patella with E-Link, Size 5, 10mm thickness Klassic Sombrero Patella, Size 5, 10mm thickness Klassic Tibial Insert, PS-Max, Standard Poly Klassic HD Acetabular Insert with E-Link Poly Distal Femoral Cut Block Connector Tibial Reamer, Square Tip Magnet Spacer, 5mm Klassic BiPolar Femoral Head Trials Femoral Neck Osteotomy Ruler Sombrero Patella Trials Universal Cut Block Bent Retrators Alignment Tower Klassic BiPolar Sizing Ring Assembly Klassic HD Acetabular Cup Sizers Klassic BiPolar Trial Flexion/Extension Cut Block A/P Sizer Domed Patella Trials Tibial Stem Extension Reamer Shaft and Stop Tibial Stem Extension Trials Klassic Femoral Head Trials Patella Sizer/Drill Guide/Tibial Stem Wrench Intramedullary Rod (IM/Rod) Klassic HD Acetabular Cup Positioner, Threaded Shaft Quick Pins Knee Slaphammer Box Chisel Femoral Neck Osteotomy Guide Tibial Stem Extension Reamer Guide Alignment Rod Klassic BiPolar Sizing Plate Tibial Baseplate Trials-Flat Tibial Stylus Pin Puller Klassic HD Acetabular Insert Trials Universal Handle Calcar Planer Patella Clamp Femoral Cut Blocks T-Handle Modular Broach Holder, Single Offset Femoral Stem Thread Adapter Slap Hammer, Hip Klassic HD Neck Trials Tibial Alignment Guides Femoral Adapter Sleeve Puller Patella Calipers Klassic HD Acetabular Cup Positioner, Handle Tibial Baseplate Trials, Keeled Patella Osteotomy Guide Modular Broach Holder, Straight Femur/Tibia Implant Impactor-Handle Varus/Valgus Cut Block Klassic BiPolar Sizing Handles Klassic® Blade Box Chisel Spiked Upper Tibial Tower Femoral Trials Klassic HD Offset Femoral Stem Trials Femoral Head Remover Klassic HD Cup Positioner, Tower Distal Femoral Cut Guide Patella Planers Tibial Insert Trials Angel Wing Tibial Insert Assembly Clamp Hip Retractors Klassic HD Non Modular Broach Holder, Straight All-Poly Tibial Broach Tower Assemblies Klassic Blade Femoral Canal Finder Rasp Anteversion Rod, Hip Klassic Blade Neck Trials Tibial Baseplate Sizers Femoral Head Trials Sterile Drill and Pin Sets Klassic® Blade Box Chisel, Curved Klassic® Blade Femoral Canal Finder Rasp, Curved Hooded Acetabular Insert Trial Tibial Stylus, Threaded Klassic BiPolar Sizing Handles, Locking MIS Cutblock - Right Stem Impaction Adapter Klassic BiPolar Trials, Locking MIS Cutblock - Left Modular Impactor Handle Simple Gap Block, Straight Modular Reamer Driver Femoral Cut Block, Pegless Tibial Insert Trial, PS-Post PS-Post Box Trial Pin Driver, 2.5mm Hex Fluted Pin, Square Head Acetabular Angled Drill Driver Acetabular Angled Drill Guide A/P Sizer, Pegless Acetabular Depth Gage Tibial Baseplate Trial, Pegless Screw Pin, Hex Head Distal Femoral Cut Guide, Modular Femur Trial, PS-Post/Revision Tibial Alignment Guide 0 degree Upper Tower PS-Post Box Resection Guide Klassic HD Femoral Canal Finder, Modular Tibial Sizer, Captured Pin, Klassic ONE Patella Sizer/ Clamp/ Drill Guide/ Reamer, Klassic ONE, Handle Femoral Cut Block, Narrow Alignment Rod, Klassic ONE Tibial Alignment Guide 6 degrees Spike Upper Tower, Klassic ONE Tibial Sizer and Trial, Klassic ONE Tibial Low Profile Cut Block, Klassic ONE, Left Tibial Broach Guide, Klassic ONE Intramedullary Rod, Klassic ONE Tibial Alignment Guide – Upper Tower, 0 degree, Klassic ONE AP Sizer, Klassic ONE Pin Driver, Triangle Tibial Alignment Guide – Lower Tower, Klassic ONE, Ankle Strap Tibial Insert Trial, PS-Max, Klassic ONE Contoura Femoral Head Trial Distal Femoral Cut Guide, Fixed Patella Caliper, Klassic ONE Fixed Distal Femoral Cut Guide, Klassic ONE Flexion/ Extension Cut Block, Klassic ONE Tibial Insert Trial, CR, Klassic ONE Tibial Insert Trial, PS-Post, Klassic ONE Universal Cut Block, Klassic ONE PS-Post Box Trial, Klassic ONE Tibial Alignment Guide – Upper Tower, 6 degree, Klassic ONE Tibial Stylus, Klassic ONE 3.2mm Stop Drill Rotating Distal Femoral Cut Guide, Klassic ONE Femoral Trial, PS-Post/ Revision, Klassic ONE Tibial Alignment Guide 0 degrees Spike Upper Tower, Klassic ONE Tibial Alignment Guide – Lower Tower, Klassic ONE Angel Wing, Klassic ONE Modular Slap Hammer Rod, Klassic ONE Tibial Alignment Guide – Upper Tower, 3 degree, Klassic ONE Tibial Baseplate Trial, Pegs, Klassic ONE Varus/ Valgus Cut Block, Klassic ONE Modular Handle/ Alignment Guide, Klassic ONE Tibial Ream Guide, Klassic ONE, 25/50mm Patella Sizer/ Clamp/ Drill Guide, Klassic ONE, Tip Patella Cement Clamp, Klassic ONE, Tip AP Sizer, Klassic ONE, Pegless Tibial Low Profile Cut Block, Klassic ONE, Right Tibial Alignment Guide 3 degrees Spike Upper Tower, Klassic ONE Femoral Shift Block Guide Pin, Triangle Head, 76mm Femoral Cut Block, Central Capture, Klassic ONE Platform® Acetabular Cup Sizers Platform® Hooded Acetabular Insert Trials Distal Femoral Augment Trial Posterior Femoral Augment Trial Universal™ Cone Trial Platform® Neutral Acetabular Insert Trials Femoral Stem Adapter Trial Revision Tibial Baseplate Sizer and Trial Intramedullary Resection Guide Adapter Femur Trial/Stem Trial Adapter Tibial Resection Tower Femoral Stem Adapter Reamer Guide Femoral Assembly Cradle Femoral Augment Alignment Guide Acetabular Reamer Adapter Stem Trial Tibial Sizer Resection Guide Adapter Distal Femoral Cut Guide with Short Pins Augment Trial, Tibial Modular Frog Eyes Klassic Sombrero Patellas Klassic HD® Femoral Head Adapter Sleeve Klassic HD® Cancellous Bone Screw Klassic HD® Acetabular Insert XLPE Klassic HD® Femoral Stem, Nonporous Klassic HD® Acetabular Cup w/Ti-Coat Klassic HD® Femoral Stem, Porous Klassic HD® Femoral Head Klassic HD® Acetabular Insert Klassic Femoral Augment, Distal Klassic Femoral Augment, Posterior Klassic Femoral Augment Screw, Posterior Klassic Tibial Augment Klassic Stem Adapter, Femoral Klassic Femoral Augment Screw, Distal Universal Cone Klassic Stem Extension, Cemented Notched Femur Impactor, PS-Post Femoral Stem Impactor with Anteversion Femur/Tibia Implant Impactor Handle Femur Extractor/Impactor Curved Acetabular Cup Impactor Modular Knee Impactor Head, Universal Femur Extractor/Impactor Head Acetabular Insert Impactor Modular Liner Impactor Head Modular Knee Impactor Head, All-Poly Tibial Impactor Head Femoral Head Impactor Universal Impactor Head Universal™ Cone Impactor Head Tibial Broach Impactor, Revision All-Poly Tibial Impactor Head Notched Femur Impactor Curved Acetabular Cup Impactor – Ball Hex Driver Modular Hip Impactor Head, Femoral Head Modular Knee Impactor Head, Femur Blade Femoral Stem Impactor, Ball Tip Blade Femoral Stem Impactor, Angled Tip Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert Klassic Knee Instrument Set Sterilization Cases Klassic HD Hip Instrument Set Sterilization Cases Klassic HD Hip Offset Instrument Set Sterilization Case Klassic BiPolar Instrument Set Sterilization Case Klassic ONE Knee CR/Ultra PS Auxiliary Instrumentation Tray Klassic ONE Knee CR/Ultra PS Primary Instrumentation Tray PS-Post™ Knee Instrument Set Klassic ONE Knee PS-Post Auxiliary Instrumentation Tray Klassic ONE Knee PS-Post Primary Instrumentation Tray Klassic® ONE, CR/Ultra-PS, PS-Post Conversion Instrumentation Tray Klassic ONE Universal Cone & Revision Baseplate Tray Klassic Knee PS-Max, Stems/Augments Instrumentation Tray Universal Cone System Instrument Case Klassic ONE Universal Cone & Revision Baseplate Tray, Pin Mat Insert Intermedullary Reamer, Revision Intramedullary Reamer Cone Reamer Guide Distal Hip Reamer Modular Cone Reamer, Handle Modular Cone Reamer, Handle Sleeve Canal Finder Reamer Universal™ Cone Reamer, Basket Tibial Stem Extension Reamer, Combined Size 100 and 150mm Tibial Reamer, Klassic ONE Tibial Stem Extension Reamer Hemispherical Acetabular Reamer PS-Post Box Reamer, Trephine PS-Post Box Reamer, Trephine, Klassic ONE Femoral Head Adaptor Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length Klassic Blade Femoral Stem, Porous Klassic Blade Offset Femoral Stem, Porous Klassic® Tibial Baseplate, Revision, Cemented Klassic® Femurs with Cobalt 3D™ Klassic® Tibial Baseplates with Ti-Coat® 3.2mm Drill 8mm Drill Femur/Patella Peg Drill 3.2mm Drill with Stop 3.2mm Drill Tip 3-in-1 Drill Klassic HD Hip System, Offset Femoral Stem, Non-porous Klassic HD Hip System, Offset Femoral Stem, Porous Klassic Tibial Stem Extensions PLATFORM® ACETABULAR CUP WITH TI-COAT® PLATFORM® ACETABULAR INSERT, NEUTRAL, E-LINK POLY PLATFORM® ACETABULAR INSERT, HOODED, E-LINK POLY Femoral Broach All-Poly Tibial Broach, Klassic ONE Modular Tibial Broach, Klassic ONE Tibial Broach Stem, Starter Revision Modular Tibial Broach All-Poly Tibial Broach Tower Assembly Klassic Blade Femoral Broach Klassic HD Modular Femoral Broach Tibial Broach Stem Anterior Starter Broach Klassic Femur, Nonporous, size 7 Klassic Knee Tibial Baseplate Klassic Knee Domed Patella Klassic Knee Femur, Nonporous Klassic Knee Tibial Set Screw Klassic Knee Tibial Dome Extension Klassic Knee Tibial Insert, Ultra-PS Klassic Knee Tibial Insert, CR/Congruent

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198