# K031826: TRIHA +

- Pathway: 510(k) (Traditional)
- Applicant: Teknimed, S.A.
- Decided: Nov 28, 2003 after 168 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). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021963: Biosorb Resorbable Void Filler, Sciences ET Bio Materiaux (Sbm) (2003). Our reading of the summary gave K021763, FDA’s number for RS2MI Muscle Stimulator Family (Rs Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BIOSORB”.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.

## Most influential descendants
- K040669: Ceraform Bone Void Filler (2004), 1 descendant of its own
- K042911: Cementek LV (2004), 0 descendants of its own

## Recalls of this device
- Aug 31, 2006 · Not classified · Z-0423-2007: The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.

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

Source page: https://510kreport.com/device/K031826
Methodology: https://510kreport.com/methodology