Company · TW
United Orthopedic Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2026. Name variants (Inc, Corp, punctuation) are merged.
61510(k) clearances (1 in 12 months)
12recalls (6 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 23 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 11 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 6 |
| LXH | Orthopedic Manual Surgical Instrument | 4 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 4 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| LWH | Counter, Sponge, Surgical | 1 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2026 | K253948 | Momentum Acetabular Cup System United Orthopedic Corporation, TW | LZO |
| Sep 25, 2025 | K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type) United Orthopedic Corporation, TW | JWH |
| Aug 22, 2025 | K252303 | Stem Extension Line (USTAR II System) United Orthopedic Corporation, TW | KRO |
| Jul 31, 2025 | K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella United Orthopedic Corporation, TW | MBH |
| May 1, 2025 | K242315 | Resolve Modular Revision Hip Stem United Orthopedic Corporation, TW | MEH |
| Jan 6, 2025 | K243466 | Conformity Stem Extension Line, #0 United Orthopedic Corporation, TW | LZO |
| Dec 20, 2024 | K243024 | Cellbrick Knee Spacer United Orthopedic Corporation, TW | JWH |
| Aug 30, 2024 | K242249 | Conformity Stem Extension Line United Orthopedic Corporation, TW | LZO |
| Feb 28, 2023 | K221705 | U2 Total Knee System-PF+ United Orthopedic Corporation, TW | MBH |
| Jan 5, 2023 | K221149 | U-Motion II Acetabular System-Extension line United Orthopedic Corporation, TW | LZO |
| Nov 4, 2022 | K221675 | United U2 femoral head, 22mm delta ceramic head United Orthopedic Corporation, TW | LPH |
| Oct 6, 2022 | K222700 | Tibial baseplate, Tibial insert United Orthopedic Corporation, TW | JWH |
| Apr 21, 2021 | K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS United Orthopedic Corporation, TW | JWH |
| Jan 3, 2020 | K191056 | Conformity stem, cemented United Orthopedic Corporation, TW | JDI |
| Sep 23, 2019 | K190100 | USTAR II System United Orthopedic Corporation, TW | KRO |
| Aug 8, 2019 | K183312 | Conformity Stem United Orthopedic Corporation, TW | LZO |
| Jun 12, 2018 | K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup United Orthopedic Corporation, TW | OQI |
| Oct 24, 2017 | K172251 | UTS Stem United Orthopedic Corporation, TW | LPH |
| Oct 6, 2017 | K170089 | U-Motion II Acetabular System Additional sizes United Orthopedic Corporation, TW | LZO |
| Aug 25, 2017 | K163441 | Locking Cage, Full XPE Cup United Orthopedic Corporation, TW | LZO |
| Jul 17, 2017 | K162957 | U2 Femoral Head United Orthopedic Corporation, TW | LPH |
| Jun 8, 2017 | K163193 | UTF Stem, reduced, #0, #00 United Orthopedic Corporation, TW | LPH |
| Mar 16, 2017 | K161705 | U2 Total Knee System E-XPE products United Orthopedic Corporation, TW | JWH |
| Feb 1, 2017 | K161360 | U2 Total Knee System, PSA Tibial Insert United Orthopedic Corporation, TW | JWH |
| Apr 12, 2016 | K152430 | All Poly Tibial Component United Orthopedic Corporation, TW | JWH |
| Apr 7, 2016 | K152439 | U2 Bipolar Implant and 22mm Femoral Head United Orthopedic Corporation, TW | KWY |
| Mar 14, 2016 | K152530 | UCP Stem United Orthopedic Corporation, TW | LZO |
| Sep 25, 2015 | K150832 | U2 Femoral Component, CR, Porous Coated, Additional Sizes United Orthopedic Corporation, TW | MBH |
| Sep 25, 2015 | K150829 | U2 Total Knee System- Additional Sizes United Orthopedic Corporation, TW | JWH |
| Aug 13, 2015 | K151316 | U2 Hip Stem, Ti Porous Coated, Matrix United Orthopedic Corporation, TW | LPH |
| Jun 16, 2014 | K140073 | U2 FEMORAL COMPONENT, CR, CEMENTED United Orthopedic Corp., TW | JWH |
| Jun 13, 2014 | K140075 | U2 FEMORAL COMPONENT, CR, POROUS COATED United Orthopedic Corp., TW | MBH |
| Mar 13, 2014 | K132752 | ULTRACONGRUENT INSERT United Orthopedic Corporation, TW | JWH |
| Jan 15, 2014 | K131864 | U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT United Orthopedic Corporation, TW | JWH |
| Oct 30, 2013 | K131116 | U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER United Orthopedic Corporation, TW | JWH |
| Sep 3, 2013 | K132455 | U-MOTION II PS+ CUP United Orthopedic Corp., TW | LZO |
| Aug 30, 2013 | K132207 | UTF STEM-REDUCED, ADDITIONAL SIZES United Orthopedic Corporation, TW | LPH |
| Jun 6, 2013 | K130149 | U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE United Orthopedic Corporation, TW | LPH |
| May 1, 2013 | K123550 | UTF STEM, REDUCED United Orthopedic Corporation, TW | LPH |
| Feb 22, 2013 | K122185 | U-MOTION II ACETABULAR SYSTEM United Orthopedic Corp., TW | LZO |
| Feb 5, 2013 | K122183 | AUGMENT AND SCREW, PSA TYPE United Orthopedic Corp., TW | JWH |
| Oct 10, 2012 | K122504 | FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH United Orthopedic Corporation, TW | LPH |
| Jul 18, 2012 | K121777 | U2 ACETABULAR CUP, PLASMA SPRAY United Orthopedic Corp., TW | LPH |
| May 4, 2012 | K120507 | UNITED U2 FEMORAL COMPONENT, PS, #7 United Orthopedic Corporation, TW | JWH |
| Sep 23, 2011 | K112463 | UNITED 36MM CERAMIC FEMORAL HEAD, DELTA United Orthopedic Corporation, TW | LZO |
| Aug 4, 2011 | K110245 | UNITED UTF STEM United Orthopedic Corporation, TW | LPH |
| Aug 2, 2011 | K103733 | UNITED U2 XPE TOTAL KNEE SYSTEM United Orthopedic Corporation, TW | JWH |
| Jul 1, 2011 | K111546 | U2 HIP SYSTEM United Orthopedic Corp., TW | LPH |
| Mar 4, 2011 | K103497 | CERAMIC FEMORAL HEAD United Orthopedic Corp., TW | MEH |
| Oct 8, 2010 | K101670 | UNITED U2 BIPOLAR IMPLANT United Orthopedic Corp., TW | KWY |
Newest 50 of 61.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2026 | United Orthopedic Corp. 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
Comp Open, Classified |
LXH | None listed |
| Aug 6, 2026 | United Orthopedic Corp. 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
Comp Open, Classified |
LWH | None listed |
| Aug 5, 2026 | United Orthopedic Corp. 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, 93 Open, Classified |
LXH | None listed |
| Aug 5, 2026 | United Orthopedic Corp. 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 Surgica Open, Classified |
LXH | None listed |
| Aug 5, 2026 | United Orthopedic Corp. 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
P Open, Classified |
KRO | K190100 |
| Aug 5, 2026 | United Orthopedic Corp. 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
Produ Open, Classified |
JWH | K082424 |
| Feb 29, 2024 | United Orthopedic Corporation USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers:
REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE251 Open, Classified |
KRO | K190100 |
| Feb 29, 2024 | United Orthopedic Corporation USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers:
REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE2515311 Open, Classified |
KRO | K190100 |
| Feb 29, 2024 | United Orthopedic Corporation 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, Open, Classified |
KRO | K190100 |
| Nov 24, 2017 | United Orthopedic Corporation 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 func Terminated |
JWH | K082424 |
| Nov 24, 2017 | United Orthopedic Corporation 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 i Terminated |
JWH | K051640 |
| Mar 1, 2017 | United Orthopedic Corporation 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. Terminated |
LXH | None listed |