Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
United Orthopedic Corp. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
254 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140073 | U2 FEMORAL COMPONENT, CR, CEMENTED | United Orthopedic Corp. | 2014-06-16 | 154 | 0 |
| K140075 | U2 FEMORAL COMPONENT, CR, POROUS COATED | United Orthopedic Corp. | 2014-06-13 | 151 | 0 |
| K132455 | U-MOTION II PS+ CUP | United Orthopedic Corp. | 2013-09-03 | 28 | 0 |
| K122185 | U-MOTION II ACETABULAR SYSTEM | United Orthopedic Corp. | 2013-02-22 | 214 | 0 |
| K122183 | AUGMENT AND SCREW, PSA TYPE | United Orthopedic Corp. | 2013-02-05 | 197 | 0 |
| K121777 | U2 ACETABULAR CUP, PLASMA SPRAY | United Orthopedic Corp. | 2012-07-18 | 30 | 1 |
| K111546 | U2 HIP SYSTEM | United Orthopedic Corp. | 2011-07-01 | 28 | 1 |
| K103497 | CERAMIC FEMORAL HEAD | United Orthopedic Corp. | 2011-03-04 | 95 | 0 |
| K101670 | UNITED U2 BIPOLAR IMPLANT | United Orthopedic Corp. | 2010-10-08 | 116 | 1 |
| K100981 | UNITED STEM, PSA TYPE | United Orthopedic Corp. | 2010-06-14 | 66 | 0 |
| K082424 | UNITED U2 TOTAL KNEE SYSTEM | United Orthopedic Corp. | 2008-12-16 | 116 | 1 |
| K082469 | UNITED U2 PATELLA | United Orthopedic Corp. | 2008-09-26 | 30 | 0 |
| K062978 | U2 HIP STEM, TI PLASMA SPRAY | United Orthopedic Corp. | 2007-01-16 | 109 | 0 |
| K051640 | U2 TOTAL KNEE SYSTEM | United Orthopedic Corp. | 2006-03-01 | 254 | 0 |
| K050269 | U1 HIP SYSTEM - BIPOLAR | United Orthopedic Corp. | 2005-08-29 | 206 | 0 |
| K050262 | U2 ACETABULAR COMPONENT | United Orthopedic Corp. | 2005-08-15 | 192 | 0 |
| K022520 | U2 ACETABULAR CUP | United Orthopedic Corp. | 2003-02-25 | 210 | 0 |
| K021657 | UKNEE TOTAL KNEE SYSTEM | United Orthopedic Corp. | 2002-08-12 | 84 | 0 |
| K003237 | U2 HIP STEM, TI POROUS COATED | United Orthopedic Corp. | 2001-01-10 | 85 | 0 |
| K994078 | U1 HIP SYSTEM | United Orthopedic Corp. | 2000-12-04 | 368 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda