United Orthopedic Corp.
FDA Regulatory Profile
United Orthopedic Corp. appears in FDA public data with 6 recalls, 20 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2885-2026, Class II) was initiated on May 20, 2026. Its most recent 510(k) clearance was granted on June 16, 2014.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 20
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2885-2026 | Class II | Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalo | May 20, 2026 |
| Z-2886-2026 | Class II | Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left a | May 20, 2026 |
| Z-2883-2026 | Class II | Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 M | May 20, 2026 |
| Z-2884-2026 | Class II | Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1- | May 20, 2026 |
| Z-2898-2026 | Class II | Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog N | March 19, 2026 |
| Z-2897-2026 | Class II | Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog N | March 19, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K140073 | U2 FEMORAL COMPONENT, CR, CEMENTED | June 16, 2014 |
| K140075 | U2 FEMORAL COMPONENT, CR, POROUS COATED | June 13, 2014 |
| K132455 | U-MOTION II PS+ CUP | September 3, 2013 |
| K122185 | U-MOTION II ACETABULAR SYSTEM | February 22, 2013 |
| K122183 | AUGMENT AND SCREW, PSA TYPE | February 5, 2013 |
| K121777 | U2 ACETABULAR CUP, PLASMA SPRAY | July 18, 2012 |
| K111546 | U2 HIP SYSTEM | July 1, 2011 |
| K103497 | CERAMIC FEMORAL HEAD | March 4, 2011 |
| K101670 | UNITED U2 BIPOLAR IMPLANT | October 8, 2010 |
| K100981 | UNITED STEM, PSA TYPE | June 14, 2010 |
| K082424 | UNITED U2 TOTAL KNEE SYSTEM | December 16, 2008 |
| K082469 | UNITED U2 PATELLA | September 26, 2008 |
| K062978 | U2 HIP STEM, TI PLASMA SPRAY | January 16, 2007 |
| K051640 | U2 TOTAL KNEE SYSTEM | March 1, 2006 |
| K050269 | U1 HIP SYSTEM - BIPOLAR | August 29, 2005 |
| K050262 | U2 ACETABULAR COMPONENT | August 15, 2005 |
| K022520 | U2 ACETABULAR CUP | February 25, 2003 |
| K021657 | UKNEE TOTAL KNEE SYSTEM | August 12, 2002 |
| K003237 | U2 HIP STEM, TI POROUS COATED | January 10, 2001 |
| K994078 | U1 HIP SYSTEM | December 4, 2000 |