# K073115: Orthomesh

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jul 15, 2008 after 253 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: 3 generations back to K974017 (1998). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033918: Ebi Lactosorb Graft Containment System, Ebi, L.P. (2004) Summary page 1.
- K003788: Synthes Resorable Meshes and Sheets, Synthes (Usa) (2001) Summary page 1.
- K960988: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 1.
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 1.
- K992158: Lactosorb Sheets, Biomet, Inc. (1999) Summary page 1.
- K003281: Lactosorb Rapidflap, Biomet, Inc. (2001) Summary page 1.
- K030069: Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation System, Synthes (Usa) (2003) Summary page 1.
- K041611: Synthes (Usa) Rapid Resorbable Cranial Clamp, Synthes (Usa) (2004) Summary page 1.
- K050204: Synthes Rapid Resorbable Tack System, Synthes (Usa) (2005) Summary page 1.
- K062789: Synthes (Usa) Rapid Resorbable Fixation System, Synthes (Usa) (2007) Summary page 1.

## Most influential descendants
- K180821: TruMatch Graft Cage - Long Bone (2018), 0 descendants of its own

## Indications for use
The Synthes OrthoMesh Resorbable Graft Containment system is indicated for use in maintaining the relative position of weak bony tissue such as bone grafts, bone graft substitutes or bone fragments from comminuted fractures. OrthoMesh implants may be used alone (without traditional rigid fixation) to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in non-load-bearing reconstructive procedures involving areas where bone stability has not been compromised, such as tumor resections and iliac crest graft harvest sites. OrthoMesh implants must be used in conjunction with traditional rigid fixation in load bearing applications to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in reconstructive procedures involving long bones, flat bones, short bones, irregular bones, appendicular skeleton and thorax. These devices are not intended for use in the spine. The devices are not intended for load bearing indications unless used in conjunction with traditional rigid fixation

Source page: https://510kreport.com/device/K073115
Methodology: https://510kreport.com/methodology