Skip to content

EXULT Knee Replacement System

by Corentec Co., Ltd 3 variants

510(k) K250889

EXULT Knee Replacement System is a Class II device made by Corentec Co., Ltd, cleared under FDA 510(k) K250889 on 17 Apr 2025, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK250889 Date17 Apr 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JWH
FDA applicant
Corentec Co., Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K250889

220 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K250889
UDI-DISize and differences
EXULT Knee Replacement System K3.IEX.3657-12T
Corentec Co., Ltd
K3.IEX.3657-12T08809945888856
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.3860-09T
Corentec Co., Ltd
K3.IEX.3860-09T08809945888771
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.3860-18T
Corentec Co., Ltd
K3.IEX.3860-18T08809945888702
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.3860-22T
Corentec Co., Ltd
K3.IEX.3860-22T08809945888689
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4063-10T
Corentec Co., Ltd
K3.IEX.4063-10T08809945888658
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4063-11T
Corentec Co., Ltd
K3.IEX.4063-11T08809945888641
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4063-18T
Corentec Co., Ltd
K3.IEX.4063-18T08809945888597
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4266-10T
Corentec Co., Ltd
K3.IEX.4266-10T08809945888542
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4266-13T
Corentec Co., Ltd
K3.IEX.4266-13T08809945888511
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4266-16T
Corentec Co., Ltd
K3.IEX.4266-16T08809945888498
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4266-18T
Corentec Co., Ltd
K3.IEX.4266-18T08809945888481
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4469-09T
Corentec Co., Ltd
K3.IEX.4469-09T08809945888443
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4469-11T
Corentec Co., Ltd
K3.IEX.4469-11T08809945888429
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4469-18T
Corentec Co., Ltd
K3.IEX.4469-18T08809945888375
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4469-22T
Corentec Co., Ltd
K3.IEX.4469-22T08809945888351
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4572-14T
Corentec Co., Ltd
K3.IEX.4572-14T08809945888283
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4572-20T
Corentec Co., Ltd
K3.IEX.4572-20T08809945888252
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4572-24T
Corentec Co., Ltd
K3.IEX.4572-24T08809945888238
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4775-14T
Corentec Co., Ltd
K3.IEX.4775-14T08809945888177
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.4775-22T
Corentec Co., Ltd
K3.IEX.4775-22T08809945888139
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.5079-10T
Corentec Co., Ltd
K3.IEX.5079-10T08809945888108
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.5079-24T
Corentec Co., Ltd
K3.IEX.5079-24T08809945888016
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.5383-11T
Corentec Co., Ltd
K3.IEX.5383-11T08809945887989
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.5383-18T
Corentec Co., Ltd
K3.IEX.5383-18T08809945887934
Single use: yes
On the market
EXULT Knee Replacement System K3.IEX.5786-11T
Corentec Co., Ltd
K3.IEX.5786-11T08809945887873
Single use: yes
On the market
EXULT Knee Replacement System KA.IUC.R212
Corentec Co., Ltd
KA.IUC.R21208809945893362
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R222
Corentec Co., Ltd
KA.IUC.R22208809945893317
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R224
Corentec Co., Ltd
KA.IUC.R22408809945893478
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R313
Corentec Co., Ltd
KA.IUC.R31308809945893546
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R314
Corentec Co., Ltd
KA.IUC.R31408809945893553
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R322
Corentec Co., Ltd
KA.IUC.R32208809945893485
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R413
Corentec Co., Ltd
KA.IUC.R41308809945893706
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R510
Corentec Co., Ltd
KA.IUC.R51008809945893836
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R513
Corentec Co., Ltd
KA.IUC.R51308809945893867
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R516
Corentec Co., Ltd
KA.IUC.R51608809945893898
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R518
Corentec Co., Ltd
KA.IUC.R51808809945893911
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R524
Corentec Co., Ltd
KA.IUC.R52408809945893966
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R611
Corentec Co., Ltd
KA.IUC.R61108809945894000
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R618
Corentec Co., Ltd
KA.IUC.R61808809945894079
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R622
Corentec Co., Ltd
KA.IUC.R62208809945893973
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R718
Corentec Co., Ltd
KA.IUC.R71808809945894239
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R913
Corentec Co., Ltd
KA.IUC.R91308809945894499
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.R914
Corentec Co., Ltd
KA.IUC.R91408809945894505
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.RA09
Corentec Co., Ltd
KA.IUC.RA0908809945894604
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.RA13
Corentec Co., Ltd
KA.IUC.RA1308809945894659
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.RA24
Corentec Co., Ltd
KA.IUC.RA2408809945894611
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.RB09
Corentec Co., Ltd
KA.IUC.RB0908809945894765
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.RB12
Corentec Co., Ltd
KA.IUC.RB1208809945894789
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.RB14
Corentec Co., Ltd
KA.IUC.RB1408809945894796
Single use: no
On the market
EXULT Knee Replacement System KA.IUC.RB20
Corentec Co., Ltd
KA.IUC.RB2008809945894826
Single use: no
On the market

Other devices from Corentec Co., Ltd

See all devices from Corentec Co., Ltd →