# K961940: Innerdyne Step Trocar Expandable Port, Onestep

- Pathway: 510(k) (Traditional)
- Applicant: Innerdyne, Inc.
- Decided: Jul 10, 1996 after 51 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: 1 generation back to K940232 (1994). 4 ancestors in all.
68 later devices descend from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943253: Innerdyne Step Trocar Expandable Port, S.T.E.P., Innerdyne Medical, Inc. (1994) Summary page 1.
- K940232: Innerdyne Step Trocar Expandable Port, S.T.E.P., Innerdyne Medical, Inc. (1994) Summary page 1.
- K950632: Innerdyne Step Trocar Expandable Port, Step, Innerdyne, Inc. (1995) Summary page 1.
- K950658: Innerdyne Step Trocar Expandable Port, Step:, Innerdyne, Inc. (1995) Summary page 1.

## Most influential descendants
- K012539: Verastep (2001), 67 descendants of its own
- K072814: Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic Procedures (2008), 59 descendants of its own
- K082619: Sils Port, Models SILSPT5, SILSPT12 (2008), 58 descendants of its own
- K090902: Spider Single Port Surgical Device, Support Arm Accessory,  Model 90001, 90002, 90003 (2009), 46 descendants of its own
- K112208: Intutive Surgical DA Vinci Single Site Instruments and Accessories (2011), 43 descendants of its own

## Recalls of this device
- Mar 1, 2023 · Class II · Z-1387-2023: Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, 

## Indications for use
The Step ®family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick.

Source page: https://510kreport.com/device/K961940
Methodology: https://510kreport.com/methodology