# K042125: AFT

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Jul 28, 2005 after 356 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Osteoset®: named in the summary without a submission number
- (no number) Exactech Resorbable Bone Paste: named in the summary without a submission number

## Recalls of this device
- Dec 22, 2023 · Class II · Z-1066-2024: Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
- Dec 22, 2023 · Class II · Z-1067-2024: Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
- Apr 21, 2016 · Class II · Z-2004-2016: AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.

## Indications for use
AFT is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. AFT is indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. AFT is intended for single patient use only.

Source page: https://510kreport.com/device/K042125
Methodology: https://510kreport.com/methodology