# K003339: Collagen Periodontal Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Jan 8, 2001 after 75 days
- Product code: NPL (Barrier, Animal Source, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- 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.
87 later devices descend from it; 3 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K012751: Healos Bone Graft Material (2001), 84 descendants of its own
- K043308: Modification to: Healos Bone Graft Material (2005), 67 descendants of its own
- K051386: Mastergraft Putty Bone Void Filler (2005), 59 descendants of its own
- K033679: Copsios Bone Void Filler (BVF) (2004), 54 descendants of its own
- K071813: Mastergraft Putty (2007), 47 descendants of its own

## Recalls of this device
- Mar 19, 2019 · Class II · Z-1389-2019: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box

Source page: https://510kreport.com/device/K003339
Methodology: https://510kreport.com/methodology