# K960267: TBM Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Biocoll Laboratories, Inc.
- Decided: Nov 5, 1996 after 292 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K043573: Dynagraft II Dental (2005), 5 descendants of its own
- K060306: Accell Connexus Demineralized Bone Matrix Putty (2006), 3 descendants of its own
- K080462: Progenix DBM Putty (2008), 2 descendants of its own
- K081950: Progenix Plus (2008), 1 descendant of its own
- K082463: Progenix (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K960267
Methodology: https://510kreport.com/methodology