# K031040: Therifil Bone Filler

- Pathway: 510(k) (Traditional)
- Applicant: Therics, Inc.
- Decided: Jul 24, 2003 after 114 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Orthovita’s Vitoss: named in the summary without a submission number
- (no number) Wright Medical’s WMT-TCP Bone Graft Substitute: named in the summary without a submission number

## Most influential descendants
- K040600: Genex Bone Graft Substitute (2004), 0 descendants of its own

## Indications for use
TheriFilTMBone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The product is intended for use in defects of the skeletal system (i. e., the extremities, spine and pelvis). TheriFilTMparts create an interlocking network within the defect site that resorbs during healing and is replaced by bone

Source page: https://510kreport.com/device/K031040
Methodology: https://510kreport.com/methodology