United Orthopedic Corp.
Hsinchu, TW
UNITED ORTHOPEDIC CORP. appears in FDA device records in Hsinchu, TW. FDA records list 60 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 12 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 60FDA records hold 60 510(k) clearances for United Orthopedic Corp. between 2000 and 2025. The busiest year on record is 2013, with 7. The most recent is 2025, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2010 | 2 |
| 2011 | 5 |
| 2012 | 3 |
| 2013 | 7 |
| 2014 | 4 |
| 2015 | 3 |
| 2016 | 3 |
| 2017 | 7 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | JWH | Substantially Equivalent | |
| K252303 | Stem Extension Line (USTAR II System) | KRO | Substantially Equivalent | |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | MBH | Substantially Equivalent | |
| K242315 | Resolve Modular Revision Hip Stem | MEH | Substantially Equivalent | |
| K243466 | Conformity Stem Extension Line, #0 | LZO | Substantially Equivalent | |
| K243024 | Cellbrick Knee Spacer | JWH | Substantially Equivalent | |
| K242249 | Conformity Stem Extension Line | LZO | Substantially Equivalent | |
| K221705 | U2 Total Knee System-PF+ | MBH | Substantially Equivalent | |
| K221149 | U-Motion II Acetabular System-Extension line | LZO | Substantially Equivalent | |
| K221675 | United U2 femoral head, 22mm delta ceramic head | LPH | Substantially Equivalent | |
| K222700 | Tibial baseplate, Tibial insert | JWH | Substantially Equivalent | |
| K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | JWH | Substantially Equivalent | |
| K191056 | Conformity stem, cemented | JDI | Substantially Equivalent | |
| K190100 | USTAR II System | KRO | Substantially Equivalent | |
| K183312 | Conformity Stem | LZO | Substantially Equivalent | |
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | OQI | Substantially Equivalent | |
| K172251 | UTS Stem | LPH | Substantially Equivalent | |
| K170089 | U-Motion II Acetabular System— Additional sizes | LZO | Substantially Equivalent | |
| K163441 | Locking Cage, Full XPE Cup | LZO | Substantially Equivalent | |
| K162957 | U2 Femoral Head | LPH | Substantially Equivalent | |
| K163193 | UTF Stem, reduced, #0, #00 | LPH | Substantially Equivalent | |
| K161705 | U2 Total Knee System E-XPE products | JWH | Substantially Equivalent | |
| K161360 | U2 Total Knee System, PSA Tibial Insert | JWH | Substantially Equivalent | |
| K152430 | All Poly Tibial Component | JWH | Substantially Equivalent | |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | KWY | Substantially Equivalent | |
| K152530 | UCP Stem | LZO | Substantially Equivalent | |
| K150832 | U2 Femoral Component, CR, Porous Coated, Additional Sizes | MBH | Substantially Equivalent | |
| K150829 | U2 Total Knee System- Additional Sizes | JWH | Substantially Equivalent | |
| K151316 | U2 Hip Stem, Ti Porous Coated, Matrix | LPH | Substantially Equivalent | |
| K140073 | U2 FEMORAL COMPONENT, CR, CEMENTED | JWH | Substantially Equivalent | |
| K140075 | U2 FEMORAL COMPONENT, CR, POROUS COATED | MBH | Substantially Equivalent | |
| K132752 | ULTRACONGRUENT INSERT | JWH | Substantially Equivalent | |
| K131864 | U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT | JWH | Substantially Equivalent | |
| K131116 | U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER | JWH | Substantially Equivalent | |
| K132455 | U-MOTION II PS+ CUP | LZO | Substantially Equivalent | |
| K132207 | UTF STEM-REDUCED, ADDITIONAL SIZES | LPH | Substantially Equivalent | |
| K130149 | U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE | LPH | Substantially Equivalent | |
| K123550 | UTF STEM, REDUCED | LPH | Substantially Equivalent | |
| K122185 | U-MOTION II ACETABULAR SYSTEM | LZO | Substantially Equivalent | |
| K122183 | AUGMENT AND SCREW, PSA TYPE | JWH | Substantially Equivalent | |
| K122504 | FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH | LPH | Substantially Equivalent | |
| K121777 | U2 ACETABULAR CUP, PLASMA SPRAY | LPH | Substantially Equivalent | |
| K120507 | UNITED U2 FEMORAL COMPONENT, PS, #7 | JWH | Substantially Equivalent | |
| K112463 | UNITED 36MM CERAMIC FEMORAL HEAD, DELTA | LZO | Substantially Equivalent | |
| K110245 | UNITED UTF STEM | LPH | Substantially Equivalent | |
| K103733 | UNITED U2 XPE TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | |
| K111546 | U2 HIP SYSTEM | LPH | Substantially Equivalent | |
| K103497 | CERAMIC FEMORAL HEAD | MEH | Substantially Equivalent | |
| K101670 | UNITED U2 BIPOLAR IMPLANT | KWY | Substantially Equivalent | |
| K100981 | UNITED STEM, PSA TYPE | JWH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681642 | 1000395711 | UNITED ORTHOPEDIC CORP. | No. 16, Luke 1st Rd. Luzhu Dist.,, Kaohsiung 82151 TW | 2026 | and 22 more, listed in full below |
| 3012329926 | 3012329926 | UNITED ORTHOPEDIC CORPORATION | 57 Park Ave. 2, Science Park, Hsinchu Hsinchu(County) TW NOTA300 TW | 2026 | and 22 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HXWBender
- HTWBit, Drill
- KTZCaliper
- HWRDriver, Prosthesis
- HWBExtractor
- HTJGauge, Depth
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- HWAImpactor
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HRSPlate, Fixation, Bone
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HWPPunch, Femoral Neck
- HTOReamer
- MQPSpinal Vertebral Body Replacement Device
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered
- HWTTemplate
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2886-2026 | Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. | Class II | Open, Classified | |
| Z-2885-2026 | Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. | Class II | Open, Classified | |
| Z-2884-2026 | Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. | Class II | Open, Classified | |
| Z-2883-2026 | Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. | Class II | Open, Classified | |
| Z-2898-2026 | Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. | Class II | Open, Classified | |
| Z-2897-2026 | Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A | Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant. | Class II | Open, Classified | |
| Z-1217-2024 | USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm | Their is a potential that the implant curved stem may be oriented incorrectly. | Class II | Open, Classified | |
| Z-1216-2024 | USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x125mm, PE25153015 - 15x100mm, PE25153215 - 15x150mm | Their is a potential that the implant curved stem may be oriented incorrectly. | Class II | Open, Classified | |
| Z-1215-2024 | USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm, | Their is a potential that the implant curved stem may be oriented incorrectly. | Class II | Open, Classified | |
| Z-1129-2018 | U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery. | UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling. | Class II | Terminated | |
| Z-1128-2018 | U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery. | UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling. | Class II | Terminated | |
| Z-1692-2017 | UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial. | The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain