United Orthopedic Corporation
United Orthopedic Corporation holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026, with 6 FDA device recalls on record.
Top product codes for United Orthopedic Corporation
FDA recalls by United Orthopedic Corporation
- Z-1216-2024 — USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x125mm, PE25153015 - 15x100mm, PE25153215 - 15x150mm
- Z-1215-2024 — 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, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,
- Z-1217-2024 — USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm
- Z-1129-2018 — 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 function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
- Z-1128-2018 — 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 improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.
- Z-1692-2017 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by United Orthopedic Corporation
- K253948 — Momentum Acetabular Cup System
- K252725 — Stem Extension Line (U2 Total Knee SystemPSA Type)
- K252303 — Stem Extension Line (USTAR II System)
- K243656 — U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella
- K242315 — Resolve Modular Revision Hip Stem
- K243466 — Conformity Stem Extension Line, #0
- K243024 — Cellbrick Knee Spacer
- K242249 — Conformity Stem Extension Line
- K221705 — U2 Total Knee System-PF+
- K221149 — U-Motion II Acetabular System-Extension line
- K221675 — United U2 femoral head, 22mm delta ceramic head
- K222700 — Tibial baseplate, Tibial insert
- K210961 — U2 Total Knee System, XPE Tibial Insert, PS PLUS
- K191056 — Conformity stem, cemented
- K190100 — USTAR II System
- K183312 — Conformity Stem
- K172833 — E-XPE Acetabular Components and U-Motion II Acetabular Cup
- K172251 — UTS Stem
- K170089 — U-Motion II Acetabular System Additional sizes
- K163441 — Locking Cage, Full XPE Cup
- K162957 — U2 Femoral Head
- K163193 — UTF Stem, reduced, #0, #00
- K161705 — U2 Total Knee System E-XPE products
- K161360 — U2 Total Knee System, PSA Tibial Insert
- K152430 — All Poly Tibial Component
- K152439 — U2 Bipolar Implant and 22mm Femoral Head
- K152530 — UCP Stem
- K150829 — U2 Total Knee System- Additional Sizes
- K150832 — U2 Femoral Component, CR, Porous Coated, Additional Sizes
- K151316 — U2 Hip Stem, Ti Porous Coated, Matrix
- K132752 — ULTRACONGRUENT INSERT
- K131864 — U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT
- K131116 — U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
- K132207 — UTF STEM-REDUCED, ADDITIONAL SIZES
- K130149 — U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
- K123550 — UTF STEM, REDUCED
- K122504 — FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
- K120507 — UNITED U2 FEMORAL COMPONENT, PS, #7
- K112463 — UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
- K110245 — UNITED UTF STEM
- K103733 — UNITED U2 XPE TOTAL KNEE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.