Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
No recalls linked.
Predicate lineage
Cited as predicate by: K103352, K110245, K111546, K112463, K121777, K122185, K122504, K123550, K151316, K162957, K163585, K172833, K242315
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-03-12 | VAI | Voluntary action indicated | United Orthopedic Corp. | 0 |
| 2026-03-12 | VAI | Voluntary action indicated | United Orthopedic Corp. | 0 |
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- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.
- 'POLARSTEM¿' Smith & Nephew, Inc.