# K982330: Depuy Orthotech Restore Orthobiologic Soft Tissue Implant

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Sep 25, 1998 after 85 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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 K921895 (1992). 8 ancestors in all.
92 later devices descend from it; 3 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970561: Graft Patch, Organogenesis, Inc. (1997) Summary page 1.
- K974540: Sis Hernia Repair Device, Sentron Medical, Inc. (1998) Summary page 1.
- K923657: Supple Peri-Guard, Bio-Vascular, Inc. (1992) Summary page 1.
- K973170: Sis Wound Dressing, Cook Biotech, Inc. (1998) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.

## Most influential descendants
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant (2003), 91 descendants of its own
- K042809: Cuffpatch (2004), 72 descendants of its own
- K052830: Sportmesh (2006), 44 descendants of its own
- K053562: Zimmer Collagen Repair Patch (2006), 41 descendants of its own
- K051766: Orthomend (2005), 35 descendants of its own

## Indications for use
The DePuy OrthoTech Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

Source page: https://510kreport.com/device/K982330
Methodology: https://510kreport.com/methodology