# K043420: Osteofil, Optefil, Regenafil, Rti Allograft Paste

- Pathway: 510(k) (Traditional)
- Applicant: Regeneration Technologies, Inc.
- Decided: Feb 10, 2005 after 59 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 13 (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; 8 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. The FDA summary names its predicate without a number.
- (no number) Pro Osteon Implant 500R Resorbable Bone Graft Substitute: named in the summary without a submission number

## Most influential descendants
- K062459: Origen DBM with Bioactive Glass (2007), 56 descendants of its own
- K072184: Vitoss Bioactive Foam Bone Graft Substitute (2007), 51 descendants of its own
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute (2008), 50 descendants of its own
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute (2008), 47 descendants of its own
- K053098: Optium DBM Gel and Putty (2005), 39 descendants of its own

## Recalls of this device
- Apr 9, 2011 · Not classified · Z-2634-2011: RTI Biologics issued a recall of Osteofil DBM Paste, 5cc that was distributed on 03/04/2008 to one customer. The product was labeled as 5.0cc but should have been labeled as 0.5cc. All customers were 
- Oct 14, 2005 · Not classified · Z-0481-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0491-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0492-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0499-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0490-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0500-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0497-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0498-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0487-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0493-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0494-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th
- Oct 14, 2005 · Not classified · Z-0496-06: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate th

## 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 bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.

Source page: https://510kreport.com/device/K043420
Methodology: https://510kreport.com/methodology