# K060096: Modular Trocar System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Jan 24, 2006 after 11 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990028 (1999). 4 ancestors in all.
10 later devices descend from it; 6 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932995: Surgical Trocar and Cannula, Applied Medical Resources (1993) Summary page 1.
- K032889: Optical Separator, Applied Medical Resources (2003) Summary page 1.

## Most influential descendants
- K083638: Fixation Trocars (2008), 4 descendants of its own
- K211577: SoftFix Balloon Trocar (2021), 2 descendants of its own
- K072674: Kii Trocar System (2007), 2 descendants of its own
- K252714: C-Lant Port (2026), 0 descendants of its own
- K233263: Disposable Trocars (2024), 0 descendants of its own

## Recalls of this device
- Dec 11, 2025 · Class II · Z-1010-2026: There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
- May 4, 2017 · Class II · Z-2533-2017: Due to possibility of insufficient sterilization.
- Dec 18, 2009 · Not classified · Z-3066-2011: The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426
- Dec 18, 2009 · Not classified · Z-3068-2011: The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426
- Dec 18, 2009 · Not classified · Z-3067-2011: The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426
- Dec 18, 2009 · Not classified · Z-3069-2011: The recall was expanded on December 22, 2009 to include four models: C0R36, C0R37, C0R38, and C0R39. Initially, Applied Medical conducted a voluntary recall on June 9, 2009 of two lot numbers, 1084426
- Jun 4, 2009 · Not classified · Z-2226-2009: Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula ti

## Indications for use
The Applied Medical Modular Trocar System is a sterile single use device, or may be used with a reusable stainless steel or reusable DuraGold© cannula and is intended for use in conjunction with Applied's currently marketed trocar products to establish a path of entry for endoscopic instruments for use during general, abdominal, gynecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments. If utilizing the Applied Medical Optical Separator Obturator with the Modular Trocar System it may be used with or without visualization for primary and secondary insertions.

Source page: https://510kreport.com/device/K060096
Methodology: https://510kreport.com/methodology