Cage, Knee
A knee cage is an external orthotic device consisting of a rigid or semi-rigid frame fitted around the knee joint to provide mediolateral stability and limit unwanted knee motion, used in the management of knee ligament injuries or instability. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITM, regulated under 21 CFR 890.3475, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- ITM
- Device Class
- FDA class 1
- Regulation Number
- 890.3475
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K832742 | EXTENSION CONTROL KNEE ORTHOSIS | Sep 20, 1983 | Substantially Equivalent | Orthomedics |
| K812064 | POLI-AXIAL KNEE CAGE | Aug 13, 1981 | Substantially Equivalent | Generation II Orthotics, Inc. |
| K770900 | CAST BRWM, FRACTURE | Jul 21, 1977 | Substantially Equivalent | Chase Mfg. Co. |
| K770899 | FRACTURE CAST BRACE, POLY | Jul 21, 1977 | Substantially Equivalent | Chase Mfg. Co. |
| K760573 | IMPROVED KNEE DRESSING | Oct 05, 1976 | Substantially Equivalent | Richard'S Medical Equip., Inc. |
FEI Numbers
This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.