# K063648: Surgi-Wrap Mast Tendon Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Mast Biosurgery USA, Inc.
- Decided: Mar 7, 2007 after 90 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 9 generations back to K921895 (1992). 44 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061473: Surgi-Wrap Mast Bioresorbable Sheet, Mast Biosurgery USA, Inc. (2006) Summary page 3.
- K053655: Tendon Wrap Tendon Protector, Integra LifeSciences Corporation (2006) Summary page 3.
- K060989: Tissuemend Soft Tissue Repair Matrix, Tei Biosciences, Inc. (2006) Summary page 3.
- K973379: Sterile Suprafoil Smooth Nylon Foil Sheets, S. Jackson, Inc. (1997) Summary page 3.

## Most influential descendants
- K072190: Ortho-Wrap Bioresorbable Sheet (2008), 10 descendants of its own
- K083823: Securian Tissue Reinforcement Matrix (2009), 9 descendants of its own
- K111584: Xylos Macro-Porous Surgical Mesh (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), 2 descendants of its own

## Indications for use
The Surgi-Wrap MAST Tendon Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the tissues. The Surgi-Wrap MAST Tendon Sheet is also indicated for reinforcement of soft tisssues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Surgi-Wrap MAST Tendon Sheet 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 Surgi-Wrap MAST Tendon Sheet reinforces soft tissue and provides a remodelable scaffold that is replaced by the patients own soft tissue. The device is indicated for open and laparoscopic / endoscopic procedures. Laparoscopic / endoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.

Source page: https://510kreport.com/device/K063648
Methodology: https://510kreport.com/methodology