# K083638: Fixation Trocars

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Dec 23, 2008 after 14 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990028 (1999). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060096: Modular Trocar System, Applied Medical Resources Corp. (2006) Summary page 1.

## Most influential descendants
- K211577: SoftFix Balloon Trocar (2021), 2 descendants of its own
- K252714: C-Lant Port (2026), 0 descendants of its own
- K233263: Disposable Trocars (2024), 0 descendants of its own
- K200517: Standard Trocar (2020), 0 descendants of its own

## Recalls of this device
- Jan 28, 2019 · Class II · Z-1959-2019: The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.

## Indications for use
Applied Medical Modular Trocar Systems are sterile, single-use devices consisting of an obturator, a cannula and seal. These systems are indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Source page: https://510kreport.com/device/K083638
Methodology: https://510kreport.com/methodology