# K053228: Therigraft TCP Putty Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Therics, LLC
- Decided: Jan 31, 2006 after 74 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K994337 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 3.

## Recalls of this device
- Aug 26, 2010 · Not classified · Z-0169-2011: The firm's quality control testing determined that a separation was occurring between the flowable carrier and the B-TriCalcium Phosphate within some of the product syringes.
- Jul 11, 2008 · Not classified · Z-2375-2008: The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.

## Indications for use
TheriGraftTM Bone Void Filler is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and is 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). TheriGraftTM putty creates a network within the defect site that resorbs during healing and is replaced by bone.

Source page: https://510kreport.com/device/K053228
Methodology: https://510kreport.com/methodology