Data / Medical devices / Taiwan / United Orthopedic Corporation
United Orthopedic Corporation: FDA-registered device maker in Hsinchu Hsinchu(County), Taiwan, 69 510(k) clearances
United Orthopedic Corporation is registered with the FDA (registration 3012329926) in Hsinchu Hsinchu(County), Taiwan. It lists 32 device types. The FDA files 69 510(k) clearances under its listings, the newest dated September 2, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012329926
- Address
- 57 Park Ave. 2, Science Park, Hsinchu Hsinchu(County), Taiwan, TW NOTA300
- Owner or operator
- UNITED ORTHOPEDIC CORPORATION (9025838)
- Roles
- 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 |
| October 7, 2004 | K042498 | VERTEX RECONSTRUCTION SYSTEM | KWP | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| October 7, 2004 | K042453 | MODIFICATION TO EQUATION FIXATION SYSTEM | MNI | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| September 4, 2003 | K032037 | CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) | MNI | Substantially Equivalent | Medtronic Sofamor Danek | 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 |
| October 24, 2001 | K010930 | LIFT VB SPINAL SYSTEM | MQP | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | 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 |
| February 18, 2000 | K994122 | BONE GRAFT WASHER, MODEL 9090114 - 9090118 | KWQ | Substantially Equivalent | Danek Medical, Inc. | accessdata.fda.gov |
| May 28, 1999 | K991528 | MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR | MNH | Substantially Equivalent | Danek Medical, Inc. | accessdata.fda.gov |
| October 5, 1998 | K982490 | TENOR SPINAL SYSTEM | KWP | Substantially Equivalent | Sofamor Danek USA,Inc. | accessdata.fda.gov |
| May 2, 1997 | K970806 | ACPII ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent for Some Indications | Sofamor Danek USA,Inc. | accessdata.fda.gov |
| December 17, 1992 | K924085 | RECONSTRUCTION PLATE SYSTEM | HRS | Substantially Equivalent for Some Indications | Sofamor Danek Mfg., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Caliper
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.