FDA product code ITM: Cage, Knee
ITM is the FDA product code for cage, knee. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 5 510(k) submissions under ITM, from 4 different applicants. The average 510(k) review took 45 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Cage, Knee |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every ITM clearance
Top ITM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chase Mfg. Co. | 2 | 1977-07-21 |
| Orthomedics | 1 | 1983-09-20 |
| Generation II Orthotics, Inc. | 1 | 1981-08-13 |
| Richard'S Medical Equip., Inc. | 1 | 1976-10-05 |
Most recent ITM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832742 | Orthomedics | EXTENSION CONTROL KNEE ORTHOSIS | 1983-09-20 | 36 |
| K812064 | Generation II Orthotics, Inc. | POLI-AXIAL KNEE CAGE | 1981-08-13 | 23 |
| K770899 | Chase Mfg. Co. | FRACTURE CAST BRACE, POLY | 1977-07-21 | 66 |
| K770900 | Chase Mfg. Co. | CAST BRWM, FRACTURE | 1977-07-21 | 66 |
| K760573 | Richard'S Medical Equip., Inc. | IMPROVED KNEE DRESSING | 1976-10-05 | 32 |
Recalls for ITM devices
openFDA lists no recalls for product code ITM.
Frequently asked questions
What is FDA product code ITM?
ITM is the FDA product code for cage, knee. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is ITM?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ITM?
Across 5 cleared submissions the average was 45 days from receipt to decision (median 36).
Which companies have the most ITM clearances?
Chase Mfg. Co. (2); Orthomedics (1); Generation II Orthotics, Inc. (1); Richard'S Medical Equip., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ITM
- Run a recall and safety report across every ITM manufacturer
- Watch product code ITM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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