# K261935: Surgical and Prosthetic Trays

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Sep 4, 2026 after 87 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: 11 generations back to K844002 (1984). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220791: Surgical and Prosthetic Trays, Dentsply Sirona (2022) Summary page 6.

## Indications for use
The Surgical and Prosthetic Trays are intended for organizing, sterilizing, and storing of instruments. The Surgical and Prosthetic Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch. Sterilization parameters Pre-vacuum steam at 132°C (270°F) for 4 minutes with a 20 minute dry time. Do not exceed the worst-case validated maximum load: Item Number: 68015277 Product Name: Astra Tech Implant System EV Surgical Tray Maximum Load (gram): 719.5 Vent to Volume Ratio (inch-1): 0.031 Item Number: 68017201 Product Name: Astra Tech Implant System EV Surgical Tray GS Maximum Load (gram): 719.5 Vent to Volume Ratio (inch-1): 0.031 Item Number: 24349 Product Name: Surgical Tray Maximum Load (gram): 1024.8 Vent to Volume Ratio (inch-1): 0.033 Item Number:31036503 Product Name: Ankylos Surgical Kit Manual ABC Maximum Load (gram): 810.6 Vent to Volume Ratio (inch-1): 1.53 Item Number: 31036513 Product Name: Ankylos Surgical Kit Manual AB Maximum Load (gram): 810.6 Vent to Volume Ratio (inch-1): 1.53 Item Number: 31036523 Product Name: Ankylos Surgical Kit Motor AB Reamer Maximum Load (gram): 810.6 Vent to Volume Ratio (inch-1): 1.53 Item Number: 31036530 Product Name: Ankylos Surgical Kit Guided Surgery Maximum Load (gram): 810.6 Vent to Volume Ratio (inch-1): 1.53 Item Number: 31036531 Product Name: Ankylos Surgical Kit Tray Guided Surgery (empty) Maximum Load (gram): 810.6 Vent to Volume Ratio (inch-1): 1.53 Item Number: 31036540 Product Name: Ankylos Surgical Kit Tray ABC Empty Maximum Load (gram): 810.6 Vent to Volume Ratio (inch-1): 1.53 Item Number: 31036542 Product Name: Ankylos Surgical Kit Tray motor AB Reamer Empty Maximum Load (gram): 810.6 Vent to Volume Ratio (inch-1): 1.53 Item Number: 31036165 Product Name: Ankylos Prosthetic Tray Mini Maximum Load (gram): 64 Vent to Volume Ratio (inch-1): 0.24

Source page: https://510kreport.com/device/K261935
Methodology: https://510kreport.com/methodology