# K090288: Orthadapt PR

- Pathway: 510(k) (Traditional)
- Applicant: Pegasus Biologics, Inc.
- Decided: May 5, 2009 after 89 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: 12 generations back to K931386 (1993). 99 ancestors in all.
7 later devices descend from it; 2 cite it directly.
1 of 107 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043388: Pegasus Biologics Orthadapt Surgical Mesh, Pegasus Biologics, Inc. (2005) Summary page 1.
- K071065: Orthadapt Bioimplant, Pegasus Biologics, Inc. (2007) Summary page 1.
- K063712: Avaulta Support System/Avaulta Plus Biosynthetic Support System, C.R. Bard, Inc. (2007) Summary page 1.
- K080185: Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP Prolapse Repair System, American Medical Systems, Inc. (2008) Summary page 1.
- K040835: Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16, Pm Devices, Inc. (2004) Summary page 1.
- K080442: Seriscaffold Surgical Mesh, Serica Technologies, Inc. (2008) Summary page 1.
- K072370: Surgicraft Surgical Mesh System, Surgicraft, Ltd. (2008) Summary page 1.

## Most influential descendants
- K112786: Proseries Bioimplants-Proankle/Procuff (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
- K261621: TekBrace Solo Soft Tissue Reinforcement Device (2026), 1 descendant of its own
- K262729: TeKBrace Solo Soft Tissue Reinforcement Device (2026), 0 descendants of its own

## Indications for use
OrthADAPT® PR 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 other 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® PR 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.

Source page: https://510kreport.com/device/K090288
Methodology: https://510kreport.com/methodology