DeviceClearance

Product code JWH— Orthopedic

ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Total cleared
915
First cleared
Most recent

Market context for product code JWH

FDA has cleared 915 devices under product code JWH between 1976 and 2026, filed by 147 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code JWH

Adverse events under product code JWH

product code JWH
Death
26
Injury
51,564
Malfunction
9,725
Other
9
Total
61,324

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

Recent clearances under product code JWH

1–100 of 915

Data sourced from openFDA. This site is unofficial and independent of the FDA.