FDA product code ISY: Joint, Knee, External Limb Component
ISY is the FDA product code for joint, knee, external limb component. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under ISY. The average 510(k) review took 103 days (median 103). FDA has posted 17 recalls for ISY devices.
Classification
| Field | Value |
|---|---|
| Device name | Joint, Knee, External Limb Component |
| Device class | Class I |
| Regulation | 21 CFR 890.3420 |
| 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 ISY clearance
Top ISY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rizzoli Ortopedica S.P.A. | 1 | 2010-10-13 |
Most recent ISY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101859 | Rizzoli Ortopedica S.P.A. | REL-K ARTIFICAL LIMB PROSTHESIS | 2010-10-13 | 103 |
Recalls for ISY devices
17 product recalls in 11 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-01-10.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 3 |
Frequently asked questions
What is FDA product code ISY?
ISY is the FDA product code for joint, knee, external limb component. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.
What device class is ISY?
Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ISY?
Across 1 cleared submissions the average was 103 days from receipt to decision (median 103).
Which companies have the most ISY clearances?
Rizzoli Ortopedica S.P.A. (1).
Have ISY devices been recalled?
Yes: 17 product recalls across 11 recall events; the most recent began 2019-01-10.
Next steps
- Run an FDA pathway report with predicate devices for product code ISY
- Run a recall and safety report across every ISY manufacturer
- Watch product code ISY 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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