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UNITED ORTHOPEDIC CORPORATION

聯合骨科器材股份有限公司

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1993Founded
NT$964MPaid-in capital
2Plants
129Certifications
8Patents
≥ NT$5BRevenue band
Unified Business No.
22099982
Industry
Other Manufacturing (2,432)
Main products
Medical devices & supplies (878)
Location
57, PARK AVE. 2, SCIENCE PARK, HSINCHU 300, TAIWAN R.O.C.
Hsinchu City (1,019) · East Dist. (401)
Listing
Listed (TPEx) (890) 4129
Registration status
Approved / Active
Organisation type
Company Limited by Shares
Founded
1993-03-05
Paid-in capital
NT$ 964,376,500
Representative
Lin Yen-sheng
Phone
(03)577-3351
Website
https://tw.unitedorthopedic.com/
Exporter
Yes — registered with the Trade Administration
Annual revenue band
≥ NT$5B
Ownership
Group subsidiary / corporate-held · Yi Sheng Co., Ltd.
North American market
FDA 510(k) clearance FDA medical device registration
Representative tenure
In office since at least 2013 (13+ years)
Growth & profitability
Revenue 2026-09 YoY -7.2%, year-to-date +10.8%
Gross margin 79%, operating margin 10%, net margin 7.4% (2026-Q2 YTD)
Compliance record
Labour Standards Act penalties: 1 case(s) in 5 years, latest 2025-10-03, fines NT$ 50,000 (Art. 24) — matched by company name

Plants 2

Certifications 129

Patents 8

  • 2023 Femoral retractor device
  • 2023 Femoral retractor hook
  • 2023 Guiding system for hip surgery implant

North American market evidence 63

  • FDA 510(k) clearance K253948 2026-09-02
    Momentum Acetabular Cup System
  • FDA 510(k) clearance K252725 2025-09-25
    Stem Extension Line (U2 Total Knee System—PSA Type)
  • FDA 510(k) clearance K252303 2025-08-22
    Stem Extension Line (USTAR II System)
  • FDA 510(k) clearance K243656 2025-07-31
    U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella
  • FDA 510(k) clearance K242315 2025-05-01
    Resolve Modular Revision Hip Stem
  • FDA 510(k) clearance K243466 2025-01-06
    Conformity Stem Extension Line, #0
  • FDA 510(k) clearance K243024 2024-12-20
    Cellbrick Knee Spacer
  • FDA 510(k) clearance K242249 2024-08-30
    Conformity Stem Extension Line
  • FDA 510(k) clearance K221705 2023-02-28
    U2 Total Knee System-PF+
  • FDA 510(k) clearance K221149 2023-01-05
    U-Motion II Acetabular System-Extension line
  • FDA 510(k) clearance K221675 2022-11-04
    United U2 femoral head, 22mm delta ceramic head
  • FDA 510(k) clearance K222700 2022-10-06
    Tibial baseplate, Tibial insert
  • FDA 510(k) clearance K210961 2021-04-21
    U2 Total Knee System, XPE Tibial Insert, PS PLUS
  • FDA 510(k) clearance K191056 2020-01-03
    Conformity stem, cemented
  • FDA 510(k) clearance K190100 2019-09-23
    USTAR II System
  • FDA 510(k) clearance K183312 2019-08-08
    Conformity Stem
  • FDA 510(k) clearance K172833 2018-06-12
    E-XPE Acetabular Components and U-Motion II Acetabular Cup
  • FDA 510(k) clearance K172251 2017-10-24
    UTS Stem
  • FDA 510(k) clearance K170089 2017-10-06
    U-Motion II Acetabular System— Additional sizes
  • FDA 510(k) clearance K163441 2017-08-25
    Locking Cage, Full XPE Cup
  • FDA 510(k) clearance K162957 2017-07-17
    U2 Femoral Head
  • FDA 510(k) clearance K163193 2017-06-08
    UTF Stem, reduced, #0, #00
  • FDA 510(k) clearance K161705 2017-03-16
    U2 Total Knee System E-XPE products
  • FDA 510(k) clearance K161360 2017-02-01
    U2 Total Knee System, PSA Tibial Insert
  • FDA 510(k) clearance K152430 2016-04-12
    All Poly Tibial Component
  • FDA 510(k) clearance K152439 2016-04-07
    U2 Bipolar Implant and 22mm Femoral Head
  • FDA 510(k) clearance K152530 2016-03-14
    UCP Stem
  • FDA 510(k) clearance K150829 2015-09-25
    U2 Total Knee System- Additional Sizes
  • FDA 510(k) clearance K150832 2015-09-25
    U2 Femoral Component, CR, Porous Coated, Additional Sizes
  • FDA 510(k) clearance K151316 2015-08-13
    U2 Hip Stem, Ti Porous Coated, Matrix
  • FDA 510(k) clearance K140073 2014-06-16
    U2 FEMORAL COMPONENT, CR, CEMENTED
  • FDA 510(k) clearance K140075 2014-06-13
    U2 FEMORAL COMPONENT, CR, POROUS COATED
  • FDA 510(k) clearance K132752 2014-03-13
    ULTRACONGRUENT INSERT
  • FDA 510(k) clearance K131864 2014-01-15
    U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT
  • FDA 510(k) clearance K131116 2013-10-30
    U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER
  • FDA 510(k) clearance K132455 2013-09-03
    U-MOTION II PS+ CUP
  • FDA 510(k) clearance K132207 2013-08-30
    UTF STEM-REDUCED, ADDITIONAL SIZES
  • FDA 510(k) clearance K130149 2013-06-06
    U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
  • FDA 510(k) clearance K123550 2013-05-01
    UTF STEM, REDUCED
  • FDA 510(k) clearance K122185 2013-02-22
    U-MOTION II ACETABULAR SYSTEM
  • FDA 510(k) clearance K122183 2013-02-05
    AUGMENT AND SCREW, PSA TYPE
  • FDA 510(k) clearance K122504 2012-10-10
    FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
  • FDA 510(k) clearance K121777 2012-07-18
    U2 ACETABULAR CUP, PLASMA SPRAY
  • FDA 510(k) clearance K120507 2012-05-04
    UNITED U2 FEMORAL COMPONENT, PS, #7
  • FDA 510(k) clearance K112463 2011-09-23
    UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
  • FDA 510(k) clearance K110245 2011-08-04
    UNITED UTF STEM
  • FDA 510(k) clearance K103733 2011-08-02
    UNITED U2 XPE TOTAL KNEE SYSTEM
  • FDA 510(k) clearance K111546 2011-07-01
    U2 HIP SYSTEM
  • FDA 510(k) clearance K103497 2011-03-04
    CERAMIC FEMORAL HEAD
  • FDA 510(k) clearance K101670 2010-10-08
    UNITED U2 BIPOLAR IMPLANT
  • FDA 510(k) clearance K100981 2010-06-14
    UNITED STEM, PSA TYPE
  • FDA 510(k) clearance K082424 2008-12-16
    UNITED U2 TOTAL KNEE SYSTEM
  • FDA 510(k) clearance K082469 2008-09-26
    UNITED U2 PATELLA
  • FDA 510(k) clearance K062978 2007-01-16
    U2 HIP STEM, TI PLASMA SPRAY
  • FDA 510(k) clearance K051640 2006-03-01
    U2 TOTAL KNEE SYSTEM
  • FDA 510(k) clearance K050269 2005-08-29
    U1 HIP SYSTEM - BIPOLAR
  • FDA 510(k) clearance K050262 2005-08-15
    U2 ACETABULAR COMPONENT
  • FDA 510(k) clearance K022520 2003-02-25
    U2 ACETABULAR CUP
  • FDA 510(k) clearance K021657 2002-08-12
    UKNEE TOTAL KNEE SYSTEM
  • FDA 510(k) clearance K003237 2001-01-10
    U2 HIP STEM, TI POROUS COATED
  • FDA 510(k) clearance K994078 2000-12-04
    U1 HIP SYSTEM
  • FDA medical device registration 3012329926 2000-12-12 – 2026-09-03
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented and more (32)
  • FDA medical device registration 9681642 2000-12-12 – 2026-09-03
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented and more (32)

Recent changes 5

  • Certification expiry · UpcomingMedical device license (Class II) certificate expires on 2026-11-15
  • Certification expiryMedical device license (Class II) certificate expired on 2026-04-23
  • Certification expiryMedical device license (Class II) certificate expired on 2026-02-03
  • Certification expiryMedical device license (Class I) certificate expired on 2025-10-23
  • PenaltiesLabour Standards Act penalties: latest case 2025-10-03; 1 case(s) in 5 years, fines NT$ 50,000

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