# K060161: Aft Allograft Filler Tube

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Mar 21, 2006 after 60 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (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
- 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 in the extremities, spine and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury. AFT is intended for single patient use only.

Source page: https://510kreport.com/device/K060161
Methodology: https://510kreport.com/methodology