Data / Medical devices / Taiwan / United Orthopedic Corp.
United Orthopedic Corp.: FDA-registered device maker in Kaohsiung, Taiwan, 60 510(k) clearances
United Orthopedic Corp. is registered with the FDA (registration 9681642) in Kaohsiung, Taiwan. It lists 32 device types. The FDA files 60 510(k) clearances under its listings, the newest dated September 2, 2026. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9681642
- FEI number
- 1000395711
- Address
- No. 16, Luke 1st Rd. Luzhu Dist., Kaohsiung, Taiwan, 82151
- Owner or operator
- UNITED ORTHOPEDIC CORPORATION (9025838)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 12, 2000
- Registered through
- 2027
- Brand names listed
- 22mm Femoral Head, All Poly Tibial Component, Atlantis Cervical Plate (ACPII ANTERIOR CERVICAL PLATE SYSTEM), Augment and Screw, PSA Type, BONE GRAFT WASHER, Bender, CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE), Caliper and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 2, 2026 | K253948 | Momentum Acetabular Cup System | LZO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| September 25, 2025 | K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| August 22, 2025 | K252303 | Stem Extension Line (USTAR II System) | KRO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| July 31, 2025 | K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella | MBH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| May 1, 2025 | K242315 | Resolve Modular Revision Hip Stem | MEH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| January 6, 2025 | K243466 | Conformity Stem Extension Line, #0 | LZO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| December 20, 2024 | K243024 | Cellbrick Knee Spacer | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| August 30, 2024 | K242249 | Conformity Stem Extension Line | LZO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| February 28, 2023 | K221705 | U2 Total Knee System-PF+ | MBH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| January 5, 2023 | K221149 | U-Motion II Acetabular System-Extension line | LZO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| November 4, 2022 | K221675 | United U2 femoral head, 22mm delta ceramic head | LPH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| October 6, 2022 | K222700 | Tibial baseplate, Tibial insert | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| April 21, 2021 | K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| January 3, 2020 | K191056 | Conformity stem, cemented | JDI | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| September 23, 2019 | K190100 | USTAR II System | KRO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| August 8, 2019 | K183312 | Conformity Stem | LZO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| June 12, 2018 | K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | OQI | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| October 24, 2017 | K172251 | UTS Stem | LPH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| October 6, 2017 | K170089 | U-Motion II Acetabular System Additional sizes | LZO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| August 25, 2017 | K163441 | Locking Cage, Full XPE Cup | LZO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| July 17, 2017 | K162957 | U2 Femoral Head | LPH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| June 8, 2017 | K163193 | UTF Stem, reduced, #0, #00 | LPH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| March 16, 2017 | K161705 | U2 Total Knee System E-XPE products | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| February 1, 2017 | K161360 | U2 Total Knee System, PSA Tibial Insert | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| April 12, 2016 | K152430 | All Poly Tibial Component | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| April 7, 2016 | K152439 | U2 Bipolar Implant and 22mm Femoral Head | KWY | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| March 14, 2016 | K152530 | UCP Stem | LZO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| September 25, 2015 | K150832 | U2 Femoral Component, CR, Porous Coated, Additional Sizes | MBH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| September 25, 2015 | K150829 | U2 Total Knee System- Additional Sizes | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| August 13, 2015 | K151316 | U2 Hip Stem, Ti Porous Coated, Matrix | LPH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| June 16, 2014 | K140073 | U2 FEMORAL COMPONENT, CR, CEMENTED | JWH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| June 13, 2014 | K140075 | U2 FEMORAL COMPONENT, CR, POROUS COATED | MBH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| March 13, 2014 | K132752 | ULTRACONGRUENT INSERT | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| January 15, 2014 | K131864 | U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| October 30, 2013 | K131116 | U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| September 3, 2013 | K132455 | U-MOTION II PS+ CUP | LZO | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| August 30, 2013 | K132207 | UTF STEM-REDUCED, ADDITIONAL SIZES | LPH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| May 1, 2013 | K123550 | UTF STEM, REDUCED | LPH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| February 22, 2013 | K122185 | U-MOTION II ACETABULAR SYSTEM | LZO | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| February 5, 2013 | K122183 | AUGMENT AND SCREW, PSA TYPE | JWH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| October 10, 2012 | K122504 | FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH | LPH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| July 18, 2012 | K121777 | U2 ACETABULAR CUP, PLASMA SPRAY | LPH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| May 4, 2012 | K120507 | UNITED U2 FEMORAL COMPONENT, PS, #7 | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| September 23, 2011 | K112463 | UNITED 36MM CERAMIC FEMORAL HEAD, DELTA | LZO | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| August 4, 2011 | K110245 | UNITED UTF STEM | LPH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| August 2, 2011 | K103733 | UNITED U2 XPE TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | United Orthopedic Corporation | accessdata.fda.gov |
| July 1, 2011 | K111546 | U2 HIP SYSTEM | LPH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| March 4, 2011 | K103497 | CERAMIC FEMORAL HEAD | MEH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| October 8, 2010 | K101670 | UNITED U2 BIPOLAR IMPLANT | KWY | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| June 14, 2010 | K100981 | UNITED STEM, PSA TYPE | JWH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| December 16, 2008 | K082424 | UNITED U2 TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| September 26, 2008 | K082469 | UNITED U2 PATELLA | JWH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| January 16, 2007 | K062978 | U2 HIP STEM, TI PLASMA SPRAY | LWJ | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| March 1, 2006 | K051640 | U2 TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| August 29, 2005 | K050269 | U1 HIP SYSTEM - BIPOLAR | KWY | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| August 15, 2005 | K050262 | U2 ACETABULAR COMPONENT | LWJ | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| February 25, 2003 | K022520 | U2 ACETABULAR CUP | LPH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| August 12, 2002 | K021657 | UKNEE TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| January 10, 2001 | K003237 | U2 HIP STEM, TI POROUS COATED | LPH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
| December 4, 2000 | K994078 | U1 HIP SYSTEM | LPH | Substantially Equivalent | United Orthopedic Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 20, 2026 | 99026 | Class II | Ongoing | 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 | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. | accessdata.fda.gov |
| March 19, 2026 | 99025 | Class II | Ongoing | 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. | accessdata.fda.gov |
| January 3, 2024 | 93858 | Class II | Ongoing | 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, | Their is a potential that the implant curved stem may be oriented incorrectly. | accessdata.fda.gov |
| November 24, 2017 | 79321 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| February 10, 2017 | 76540 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Orthosis, Spondylolisthesis Spinal Fixation
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Updated September 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.