# K040980: Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite Scaffold, Models 860C, 86XC, 86DR, 860D, 860T

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jul 14, 2004 after 90 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 4 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K040419: Dynagraft II (2005), 28 descendants of its own
- K050642: Orthoblast II Putty and Paste (2005), 8 descendants of its own
- K050690: Connexus (2005), 6 descendants of its own
- K061880: Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC (2007), 5 descendants of its own
- K113728: Surfuse Gel and Putty, Exfuse Gel and Putty (2012), 4 descendants of its own

## Indications for use
ALLOMATRIX® C Putty, ALLOMATRIX® Custom Putty and ALLOMATRIX® DR Putty are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® C Putty, ALLOMATRIX® Custom Putty and ALLOMATRIX® DR Putty are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Source page: https://510kreport.com/device/K040980
Methodology: https://510kreport.com/methodology