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Data / Medical devices / United States / UOC USA Inc.

UOC USA Inc.: FDA-registered device maker in Irvine, CA, United States, 68 510(k) clearances

UOC USA Inc. is registered with the FDA (registration 3009760038) in Irvine, CA, United States. It lists 32 device types. The FDA files 68 510(k) clearances under its listings, the newest dated September 25, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch UOC USA Inc.
FDA registration number
3009760038
Address
16601 Hale Ave, Irvine, CA, United States, 92606
Owner or operator
UNITED ORTHOPEDIC CORPORATION (9025838)
Roles
Manufacturer, Manufacturer for export
First device listed
December 12, 2000
Registered through
2026
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

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Manufacturer, Manufacturer for exportaccessdata.fda.gov
BenderHXW1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Bit, DrillHTW1Manufacturer, Manufacturer for exportaccessdata.fda.gov
CaliperKTZ1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Driver, ProsthesisHWR1Manufacturer, Manufacturer for exportaccessdata.fda.gov
ExtractorHWB1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Gauge, DepthHTJ1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous UncementedOQI2Manufacturer, Manufacturer for exportaccessdata.fda.gov
ImpactorHWA1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, MetalKWL2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedLWJ2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateMEH2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerKRO2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOIY2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Punch, Femoral NeckHWP1Manufacturer, Manufacturer for exportaccessdata.fda.gov
ReamerHTO1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Table, Surgical With Orthopedic Accessories, Ac-PoweredJEA1Manufacturer, Manufacturer for exportaccessdata.fda.gov
TemplateHWT1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufacturer, Manufacturer for exportaccessdata.fda.gov
WrenchHXC1Manufacturer, Manufacturer for exportaccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 25, 2025K252725Stem Extension Line (U2 Total Knee System—PSA Type)JWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
August 22, 2025K252303Stem Extension Line (USTAR II System)KROSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
July 31, 2025K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaMBHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
May 1, 2025K242315Resolve Modular Revision Hip StemMEHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
January 6, 2025K243466Conformity Stem Extension Line, #0LZOSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
December 20, 2024K243024Cellbrick Knee SpacerJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
August 30, 2024K242249Conformity Stem Extension LineLZOSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
February 28, 2023K221705U2 Total Knee System-PF+MBHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
January 5, 2023K221149U-Motion II Acetabular System-Extension lineLZOSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
November 4, 2022K221675United U2 femoral head, 22mm delta ceramic headLPHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
October 6, 2022K222700Tibial baseplate, Tibial insertJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
April 21, 2021K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
January 3, 2020K191056Conformity stem, cementedJDISubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
September 23, 2019K190100USTAR II SystemKROSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
August 8, 2019K183312Conformity StemLZOSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
June 12, 2018K172833E-XPE Acetabular Components and U-Motion II Acetabular CupOQISubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
October 24, 2017K172251UTS StemLPHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
October 6, 2017K170089U-Motion II Acetabular System— Additional sizesLZOSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
August 25, 2017K163441Locking Cage, Full XPE CupLZOSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
July 17, 2017K162957U2 Femoral HeadLPHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
June 8, 2017K163193UTF Stem, reduced, #0, #00LPHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
March 16, 2017K161705U2 Total Knee System E-XPE productsJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
February 1, 2017K161360U2 Total Knee System, PSA Tibial InsertJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
April 12, 2016K152430All Poly Tibial ComponentJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
April 7, 2016K152439U2 Bipolar Implant and 22mm Femoral HeadKWYSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
March 14, 2016K152530UCP StemLZOSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
September 25, 2015K150832U2 Femoral Component, CR, Porous Coated, Additional SizesMBHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
September 25, 2015K150829U2 Total Knee System- Additional SizesJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
August 13, 2015K151316U2 Hip Stem, Ti Porous Coated, MatrixLPHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
June 16, 2014K140073U2 FEMORAL COMPONENT, CR, CEMENTEDJWHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
June 13, 2014K140075U2 FEMORAL COMPONENT, CR, POROUS COATEDMBHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
March 13, 2014K132752ULTRACONGRUENT INSERTJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
January 15, 2014K131864U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENTJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
October 30, 2013K131116U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTERJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
September 3, 2013K132455U-MOTION II PS+ CUPLZOSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
August 30, 2013K132207UTF STEM-REDUCED, ADDITIONAL SIZESLPHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
May 1, 2013K123550UTF STEM, REDUCEDLPHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
February 22, 2013K122185U-MOTION II ACETABULAR SYSTEMLZOSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
February 5, 2013K122183AUGMENT AND SCREW, PSA TYPEJWHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
October 10, 2012K122504FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTHLPHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
July 18, 2012K121777U2 ACETABULAR CUP, PLASMA SPRAYLPHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
May 4, 2012K120507UNITED U2 FEMORAL COMPONENT, PS, #7JWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
September 23, 2011K112463UNITED 36MM CERAMIC FEMORAL HEAD, DELTALZOSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
August 4, 2011K110245UNITED UTF STEMLPHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
August 2, 2011K103733UNITED U2 XPE TOTAL KNEE SYSTEMJWHSubstantially EquivalentUnited Orthopedic Corporationaccessdata.fda.gov
July 1, 2011K111546U2 HIP SYSTEMLPHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
March 4, 2011K103497CERAMIC FEMORAL HEADMEHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
October 8, 2010K101670UNITED U2 BIPOLAR IMPLANTKWYSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
June 14, 2010K100981UNITED STEM, PSA TYPEJWHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
December 16, 2008K082424UNITED U2 TOTAL KNEE SYSTEMJWHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
September 26, 2008K082469UNITED U2 PATELLAJWHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
January 16, 2007K062978U2 HIP STEM, TI PLASMA SPRAYLWJSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
March 1, 2006K051640U2 TOTAL KNEE SYSTEMJWHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
August 29, 2005K050269U1 HIP SYSTEM - BIPOLARKWYSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
August 15, 2005K050262U2 ACETABULAR COMPONENTLWJSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
October 7, 2004K042498VERTEX RECONSTRUCTION SYSTEMKWPSubstantially EquivalentMedtronic Sofamor Danekaccessdata.fda.gov
October 7, 2004K042453MODIFICATION TO EQUATION FIXATION SYSTEMMNISubstantially EquivalentMedtronic Sofamor Danek, Inc.accessdata.fda.gov
September 4, 2003K032037CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)MNISubstantially EquivalentMedtronic Sofamor Danekaccessdata.fda.gov
February 25, 2003K022520U2 ACETABULAR CUPLPHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
August 12, 2002K021657UKNEE TOTAL KNEE SYSTEMJWHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
October 24, 2001K010930LIFT VB SPINAL SYSTEMMQPSubstantially EquivalentMedtronic Sofamor Danek, Inc.accessdata.fda.gov
January 10, 2001K003237U2 HIP STEM, TI POROUS COATEDLPHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
December 4, 2000K994078U1 HIP SYSTEMLPHSubstantially EquivalentUnited Orthopedic Corp.accessdata.fda.gov
February 18, 2000K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118KWQSubstantially EquivalentDanek Medical, Inc.accessdata.fda.gov
May 28, 1999K991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORMNHSubstantially EquivalentDanek Medical, Inc.accessdata.fda.gov
October 5, 1998K982490TENOR SPINAL SYSTEMKWPSubstantially EquivalentSofamor Danek USA,Inc.accessdata.fda.gov
May 2, 1997K970806ACPII ANTERIOR CERVICAL PLATE SYSTEMKWQSubstantially Equivalent for Some IndicationsSofamor Danek USA,Inc.accessdata.fda.gov
December 17, 1992K924085RECONSTRUCTION PLATE SYSTEMHRSSubstantially Equivalent for Some IndicationsSofamor Danek Mfg., Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 27, 202188692Class IITerminatedUnited Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Catalog # 2915-1025Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.accessdata.fda.gov

Compare with other makers

Updated September 25, 2025. 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.