# K052735: Allocraft DBM

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corp.
- Decided: Dec 28, 2005 after 89 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: 2 (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) Musculoskeletal Transplant Foundation's DBX® Demineralized Bone Matrix: named in the summary without a submission number
- (no number) Wright Medical's AlloMatrix®: named in the summary without a submission number
- (no number) Exactech's Resorbable Bone Paste: named in the summary without a submission number

## Recalls of this device
- Oct 17, 2007 · Not classified · Z-1299-2008: Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reac
- Oct 17, 2007 · Not classified · Z-1298-2008: Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reac

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

Source page: https://510kreport.com/device/K052735
Methodology: https://510kreport.com/methodology