Medical Device Manufacturer · TW , Hsinchu

United Orthopedic Corporation

40 submissions · 40 cleared · Since 2011
40
Total
40
Cleared
0
Denied

United Orthopedic Corporation — FDA 510(k) Submissions

United Orthopedic Corporation has submitted 40 FDA 510(k) premarket notifications since 2011, of which 40 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer, Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer . Use the specialty filter in the sidebar to narrow results.

40 devices
1–25 of 40
Stem Extension Line (U2 Total Knee System?PSA Type)
K252725 · JWH Prosthesis, Knee,... · Orthopedic
Sep 2025 28d
Stem Extension Line (USTAR II System)
K252303 · KRO Prosthesis, Knee,... · Orthopedic
Aug 2025 29d
U2 Total Knee System ? PF+ Patella; USTAR II System? PF+ Patella
K243656 · MBH Prosthesis, Knee,... · Orthopedic
Jul 2025 247d
Resolve Modular Revision Hip Stem
K242315 · MEH Prosthesis, Hip,... · Orthopedic
May 2025 269d
Conformity Stem Extension Line, #0
K243466 · LZO Prosthesis, Hip,... · Orthopedic
Jan 2025 59d
Cellbrick Knee Spacer
K243024 · JWH Prosthesis, Knee,... · Orthopedic
Dec 2024 84d
Conformity Stem Extension Line
K242249 · LZO Prosthesis, Hip,... · Orthopedic
Aug 2024 30d
U2 Total Knee System-PF+
K221705 · MBH Prosthesis, Knee,... · Orthopedic
Feb 2023 260d
U-Motion II Acetabular System-Extension line
K221149 · LZO Prosthesis, Hip,... · Orthopedic
Jan 2023 260d
United U2 femoral head, 22mm delta ceramic head
K221675 · LPH Prosthesis, Hip,... · Orthopedic
Nov 2022 148d
Tibial baseplate, Tibial insert
K222700 · JWH Prosthesis, Knee,... · Orthopedic
Oct 2022 29d
U2 Total Knee System, XPE Tibial Insert, PS PLUS
K210961 · JWH Prosthesis, Knee,... · Orthopedic
Apr 2021 21d
Conformity stem, cemented
K191056 · JDI Prosthesis, Hip,... · Orthopedic
Jan 2020 259d
USTAR II System
K190100 · KRO Prosthesis, Knee,... · Orthopedic
Sep 2019 244d
Conformity Stem
K183312 · LZO Prosthesis, Hip,... · Orthopedic
Aug 2019 252d
E-XPE Acetabular Components and U-Motion II Acetabular Cup
K172833 · OQI Hip, Semi-constrained,... · Orthopedic
Jun 2018 266d
UTS Stem
K172251 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2017 90d
U-Motion II Acetabular System? Additional sizes
K170089 · LZO Prosthesis, Hip,... · Orthopedic
Oct 2017 269d
Locking Cage, Full XPE Cup
K163441 · LZO Prosthesis, Hip,... · Orthopedic
Aug 2017 260d
U2 Femoral Head
K162957 · LPH Prosthesis, Hip,... · Orthopedic
Jul 2017 266d
UTF Stem, reduced, #0, #00
K163193 · LPH Prosthesis, Hip,... · Orthopedic
Jun 2017 205d
U2 Total Knee System E-XPE products
K161705 · JWH Prosthesis, Knee,... · Orthopedic
Mar 2017 269d
U2 Total Knee System, PSA Tibial Insert
K161360 · JWH Prosthesis, Knee,... · Orthopedic
Feb 2017 261d
All Poly Tibial Component
K152430 · JWH Prosthesis, Knee,... · Orthopedic
Apr 2016 230d
U2 Bipolar Implant and 22mm Femoral Head
K152439 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Apr 2016 224d
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