# K121216: STR Graft

- Pathway: 510(k) (Traditional)
- Applicant: Soft Tissue Regeneration, Inc.
- Decided: Nov 21, 2012 after 212 days
- Product code: OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon)
- 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: 10 generations back to K921895 (1992). 37 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083307: Synthasome X-Repair, Synthasome, Inc. (2009) Summary page 1.
- K071887: Sportmesh or Artelon Tissue Reinforcement, Artimplant AB (2007) Summary page 1.
- K052830: Sportmesh, Artimplant AB (2006) Summary page 1.

## Most influential descendants
- K203267: The BioBrace Implant (2021), 4 descendants of its own
- K241906: BioBrace®  Reinforced Implant (2024), 3 descendants of its own
- K242187: BioBrace® (2024), 1 descendant of its own
- K252946: BioBrace® Extra-Articular Ligament Augmentation Kit (2025), 0 descendants of its own
- K250395: BioBrace ® RC Delivery System (2025), 0 descendants of its own

## Indications for use
The STIR GRAFT is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The STIR GRAFT is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The STIR GRAFT is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the tendon repair.

Source page: https://510kreport.com/device/K121216
Methodology: https://510kreport.com/methodology