# K031969: Depuy Restore Orthobiologic Soft Tissue Implant

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jul 28, 2003 after 32 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: 5 generations back to K921895 (1992). 24 ancestors in all.
91 later devices descend from it; 8 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982330: Depuy Orthotech Restore Orthobiologic Soft Tissue Implant, Depuy, Inc. (1998) Summary page 1.
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000)

## Most influential descendants
- 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
- K071887: Sportmesh or Artelon Tissue Reinforcement (2007), 28 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, during rotator cuff repair surgery. The Restore@Implant is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures to repair the tear and suture or bone anchors to reattach the tissue to the bone provide mechanical strength for the rotator cuff repair. The Restore@Implant reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient’s own soft tissue.

Source page: https://510kreport.com/device/K031969
Methodology: https://510kreport.com/methodology