Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

United Orthopedic Corporation · Predicate Candidate Screening

40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

191 daysmedian FDA review time
266 days90th percentile
40clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation2025-09-25280
K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation2025-08-22290
K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatUnited Orthopedic Corporation2025-07-312470
K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation2025-05-012690
K243466Conformity Stem Extension Line, #0United Orthopedic Corporation2025-01-06590
K243024Cellbrick Knee SpacerUnited Orthopedic Corporation2024-12-20840
K242249Conformity Stem Extension LineUnited Orthopedic Corporation2024-08-30300
K221705U2 Total Knee System-PF+United Orthopedic Corporation2023-02-282600
K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation2023-01-052600
K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation2022-11-041480
K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation2022-10-06290
K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation2021-04-21210
K191056Conformity stem, cementedUnited Orthopedic Corporation2020-01-032590
K190100USTAR II SystemUnited Orthopedic Corporation2019-09-232444
K183312Conformity StemUnited Orthopedic Corporation2019-08-082520
K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018-06-122660
K172251UTS StemUnited Orthopedic Corporation2017-10-24900
K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation2017-10-062690
K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation2017-08-252600
K162957U2 Femoral HeadUnited Orthopedic Corporation2017-07-172660
K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation2017-06-082050
K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation2017-03-162690
K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation2017-02-012610
K152430All Poly Tibial ComponentUnited Orthopedic Corporation2016-04-122300
K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation2016-04-072240
K152530UCP StemUnited Orthopedic Corporation2016-03-141930
K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation2015-09-251790
K150832U2 Femoral Component, CR, Porous Coated, Additional SizesUnited Orthopedic Corporation2015-09-251790
K151316U2 Hip Stem, Ti Porous Coated, MatrixUnited Orthopedic Corporation2015-08-13870
K132752ULTRACONGRUENT INSERTUnited Orthopedic Corporation2014-03-131910
K131864U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENTUnited Orthopedic Corporation2014-01-152050
K131116U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTERUnited Orthopedic Corporation2013-10-301910
K132207UTF STEM-REDUCED, ADDITIONAL SIZESUnited Orthopedic Corporation2013-08-30450
K130149U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USEUnited Orthopedic Corporation2013-06-061350
K123550UTF STEM, REDUCEDUnited Orthopedic Corporation2013-05-011630
K122504FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTHUnited Orthopedic Corporation2012-10-10550
K120507UNITED U2 FEMORAL COMPONENT, PS, #7United Orthopedic Corporation2012-05-04731
K112463UNITED 36MM CERAMIC FEMORAL HEAD, DELTAUnited Orthopedic Corporation2011-09-23281
K110245UNITED UTF STEMUnited Orthopedic Corporation2011-08-041891
K103733UNITED U2 XPE TOTAL KNEE SYSTEMUnited Orthopedic Corporation2011-08-022232

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