# K083307: Synthasome X-Repair

- Pathway: 510(k) (Traditional)
- Applicant: Synthasome, Inc.
- Decided: Mar 27, 2009 after 137 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). 36 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071887: Sportmesh or Artelon Tissue Reinforcement, Artimplant AB (2007) Summary page 1.
- K052830: Sportmesh, Artimplant AB (2006) Summary page 1.
- K810428: Vicryl, ETHICON, Inc. (1981) Summary page 1.

## Most influential descendants
- K121216: STR Graft (2012), 5 descendants of its own
- 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

## Indications for use
X-Repair is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. X-Repair 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. X-Repair is not intended to replace normal body structure 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 the bone, provide mechanical strength for the tendon repair.

Source page: https://510kreport.com/device/K083307
Methodology: https://510kreport.com/methodology