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
- K163293
Cited as predicate by: K172300, K181113, K181843, K182402, K190385, K190391, K191535, K193543, K200762, K201149, K203698, K210060, K212487, K213069, K213698
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 |
|---|---|---|---|---|
| 2019-03-08 | VAI | Voluntary action indicated | In2bones USA, LLC | 3 |
| 2019-03-08 | VAI | Voluntary action indicated | In2bones USA, LLC | 3 |
- 3.3mm Screw Fastener Self Tapping 14mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 16mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 18mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 20mm Osteocentric Technologies, Inc.
- 4.0 x 22mm LOCKING BONE SCREW FASTENER ST Osteocentric Technologies, Inc.
- Biosteon® IntraLine® BIOCOMPOSITES LTD
- CORTICAL BONE SCREW 3.5mm x 16mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CORTICAL BONE SCREW 3.5mm x 20mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CORTICAL BONE SCREW 3.5mm x 24mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CORTICAL BONE SCREW 3.5mm x 26mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Container FOURNITURES HOSPITALIERES INDUSTRIE
- Locking Fibula Plate, 5 Holes FLOWER ORTHOPEDICS CORPORATION