# K033552: Jax-TCP

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 10, 2004 after 211 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.
4 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)
- None. The FDA summary names no predicate by number.

## 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

## Indications for use
The Jax-tcp granules may be used alone or can be mixed with the gel to create a cohesive mass that can be applied to the defect site. The get is contradicted for use without the use of the granules. When used together, the granules and gel should be combined in a 1:1 ratio. JAX-tcp is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. JAX-tcp is indicated to be gently packed into bony voids or gaps of the skeletal system, (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. JAX-tcp provides a filter that is resorbed and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K033552
Methodology: https://510kreport.com/methodology