# K053098: Optium DBM Gel and Putty

- Pathway: 510(k) (Traditional)
- Applicant: Lifenet
- Decided: Nov 28, 2005 after 25 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963562 (1997). 7 ancestors in all.
39 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020895: Allomatrix Model# 86, Wrightmedicaltechnologyinc (2004) Summary page 1.
- K041168: Allomatrix Putty, Wrightmedicaltechnologyinc (2004) Summary page 1.
- K043420: Osteofil, Optefil, Regenafil, Rti Allograft Paste, Regeneration Technologies, Inc. (2005) Summary page 1.
- K020078: Exactech Resorbable Bone Paste, Exactech, Inc. (2004) Summary page 1.

## Most influential descendants
- K063050: Cap Plus (2007), 34 descendants of its own
- K080329: Cap Plus, Equivabone, Cap/DBM (2008), 29 descendants of its own
- K090310: Equivabone (2009), 28 descendants of its own
- K090855: Equivabone Osteoinductive Bone Graft Substitute (2009), 25 descendants of its own
- K093447: Carrigen (2010), 21 descendants of its own

## Indications for use
These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into the bony voids or gaps of the skeletal system (e.g., extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone void filler that remodels into the recipient's skeletal system.

Source page: https://510kreport.com/device/K053098
Methodology: https://510kreport.com/methodology