# K041421: Name Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Biotech
- Decided: Aug 26, 2004 after 90 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
Longest line of descent: 2 generations back to K994337 (2000). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 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 2.
- K021963: Biosorb Resorbable Void Filler, Sciences ET Bio Materiaux (Sbm) (2003) Summary page 2.
- K010555: JAX, Smith & Nephew, Inc. (2003) Summary page 2.
- K020895: Allomatrix Model# 86, Wrightmedicaltechnologyinc (2004) Summary page 2.

## Most influential descendants
- K051722: Tricos T (2005), 3 descendants of its own
- K073571: Tricos T Resorbable Bone Substitute (2008), 2 descendants of its own
- K081717: Tricos a Resorbable Bone Substitute (2008), 0 descendants of its own
- K081721: Tricos a Resorbable Substitute (2008), 0 descendants of its own

## Recalls of this device
- Aug 16, 2006 · Not classified · Z-0254-2007: Lack of Labeling Precautions. Calstrux should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with ov

## Indications for use
TCP Putty is indicated as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. It should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. TCP Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, the tri-calcium phosphate scaffold is resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K041421
Methodology: https://510kreport.com/methodology