# K001738: Depuy Restore Orthobiologic Soft Tissue Implant

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 27, 2000 after 203 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: 4 generations back to K921895 (1992). 22 ancestors in all.
173 later devices descend from it; 10 cite it directly.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K973170: Sis Wound Dressing, Cook Biotech, Inc. (1998) Summary page 1.
- K993948: Sis Wound Dressing II, Cook Biotech, Inc. (2000) Summary page 1.
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc, Bio-Vascular, Inc. (1998) Summary page 1.
- K970561: Graft Patch, Organogenesis, Inc. (1997) Summary page 1.
- K974540: Sis Hernia Repair Device, Sentron Medical, Inc. (1998) Summary page 1.

## Most influential descendants
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant (2003), 91 descendants of its own
- K042809: Cuffpatch (2004), 72 descendants of its own
- K021056: Permacol (2002), 51 descendants of its own
- K043388: Pegasus Biologics Orthadapt Surgical Mesh (2005), 49 descendants of its own

## Indications for use
The DePuy Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues which are repaired by suture or suture anchors limited to the supraspinatus during rotator cuff repair surgery.

Source page: https://510kreport.com/device/K001738
Methodology: https://510kreport.com/methodology