# K043388: Pegasus Biologics Orthadapt Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Pegasus Biologics, Inc.
- Decided: Aug 5, 2005 after 239 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: 6 generations back to K921895 (1992). 25 ancestors in all.
49 later devices descend from it; 4 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020049: Fortaflex Surgical Mesh, Organogenesis, Inc. (2002) Summary page 1.
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K071065: Orthadapt Bioimplant (2007), 44 descendants of its own
- K071887: Sportmesh or Artelon Tissue Reinforcement (2007), 28 descendants of its own
- K061892: Propatch Soft Tissue Repair Matrix (2006), 17 descendants of its own
- K071016: Depuy Restore Orthobiologic Soft Tissue Implant (2007), 13 descendants of its own
- 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

## Indications for use
The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. OrthADAPT® 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. OrthADAPT® is intended for one-time use only.

Source page: https://510kreport.com/device/K043388
Methodology: https://510kreport.com/methodology