# K071016: Depuy Restore Orthobiologic Soft Tissue Implant

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Sep 4, 2007 after 147 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: 8 generations back to K921895 (1992). 45 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K061892: Propatch Soft Tissue Repair Matrix, Cryolife, Inc. (2006) Summary page 1.
- K033671: Gore Bioabsorbable Mesh, W. L. Gore & Associates, Inc. (2003) Summary page 1.

## Most influential descendants
- K073219: WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6 CM X 8 CM, Model 89XM-6X08 (2008), 12 descendants of its own
- K120019: Collagen Ribbon (2012), 11 descendants of its own
- K131143: Trellis Collagen Ribbon (2013), 10 descendants of its own
- K151083: BioBridge Collagen Matrix (2016), 9 descendants of its own
- K222978: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own

## Indications for use
The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

Source page: https://510kreport.com/device/K071016
Methodology: https://510kreport.com/methodology