# K203753: Straumann Surgical Cassettes

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA, LLC
- Decided: Jul 29, 2021 after 218 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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 K844002 (1984). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180791: Straumann BLX Surgical Cassette, Institut Straumann AG (2018) Summary page 4.
- K191522: Straumann Modular Cassette, Institut Straumann AG (2019) Summary page 5.

## Most influential descendants
- K233264: Anthogyr INTEGRAL Guided Surgery Cassettes (2023), 0 descendants of its own

## Indications for use
The Straumann Cassettes are used to organize, store, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals. The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time. The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments.

Source page: https://510kreport.com/device/K203753
Methodology: https://510kreport.com/methodology