# K040134: Therilink Bone Void Filler

- Pathway: 510(k) (Special)
- Applicant: Therics, Inc.
- Decided: Mar 9, 2004 after 48 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Therics' TheriFill Bone Void Filler: named in the summary without a submission number
- (no number) Orthovita's Vitoss: named in the summary without a submission number

## Recalls of this device
- Aug 26, 2008 · Not classified · Z-1965-2009: Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.

## Indications for use
TheriLink TM Bone 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). TheriLinkTM parts create a network within the defect site that resorbs during healing and is replaced by bone.

Source page: https://510kreport.com/device/K040134
Methodology: https://510kreport.com/methodology