UNITED U2 TOTAL KNEE SYSTEM— 510(k) K082424

Clearance details

Applicant

United Orthopedic Corp.

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2008-08-22

Decision date

2008-12-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hsinchu, TW

• K260063 — GSPE Spacer2026-09-11
• K262293 — EVOLUTION MPX Total Knee System2026-09-10
• K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
• K262130 — ATTUNE Revision Knee System2026-09-04
• K253961 — SK Knee System2026-09-01

• K140073 — U2 FEMORAL COMPONENT, CR, CEMENTED2014-06-16
• K140075 — U2 FEMORAL COMPONENT, CR, POROUS COATED2014-06-13
• K132455 — U-MOTION II PS+ CUP2013-09-03
• K122185 — U-MOTION II ACETABULAR SYSTEM2013-02-22
• K122183 — AUGMENT AND SCREW, PSA TYPE2013-02-05

Death

26

Injury

51,564

Malfunction

9,725

Other

9

Total

61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2883-2026 — Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/AClass II·Ongoing·United Orthopedic Corp.·20260520
• 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.Class II·Terminated·United Orthopedic Corporation·20171124

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082424.