# K180821: TruMatch Graft Cage - Long Bone

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa), LLC
- Decided: Dec 21, 2018 after 266 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K974017 (1998). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073115: Orthomesh, Synthes (Usa) (2008) Summary page 4.

## Indications for use
The DePuy Synthes TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally mature adults and adolescents (12-21)* for maintaining the relative position of bone grafts and/or bone graft substitutes within bone voids or surgical resections in the nonarticular regions of the humerus, femur, or tibia. The implant must be used in conjunction with traditional, rigid fixation. *The TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally immature adolescents, only if the device is not used across open physes. The TruMatch Graft Cage – Long Bone implant is for patients only when the treating physician deems there is appropriate time to conduct surgical planning, personalization, and manufacturing of a patient specific device. When considering the use of the TruMatch Graft Cage - Long Bone, please ensure that you request information on the amount of time needed to manufacture and ship the device from your local DePuy Synthes sales representative. There is a delay between when the device is ordered and when the device can be delivered.

Source page: https://510kreport.com/device/K180821
Methodology: https://510kreport.com/methodology