Joint, Knee, External Limb Component
A knee joint external limb component is a prosthetic knee unit for transfemoral amputees that provides controlled articulation at the knee level, supporting stance stability and swing-phase motion during ambulation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISY, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- ISY
- Device Class
- FDA class 1
- Regulation Number
- 890.3420
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K101859 | REL-K ARTIFICAL LIMB PROSTHESIS | Oct 13, 2010 | Substantially Equivalent | Rizzoli Ortopedica S.P.A. |
FEI Numbers
This FDA classification entry is associated with 65 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 65 registration numbers. Click on an entry to view related FDA registrations.