# K151347: MIS Spine Frame Instrument Case

- Pathway: 510(k) (Traditional)
- Applicant: Thompson Surgical Instruments
- Decided: Oct 16, 2015 after 149 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: 8 generations back to K844002 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131170: Sonicision Sterilization Tray, Covidien, Formerly Valleylab, A Division of Tyco H (2013) Summary page 5.

## Indications for use
Thompson Surgical Instruments MIS Spine Frame Instrument Case is intended for use in healthcare facilities to store, transport, organize, and sterilize surgical instruments such as retractor blades, retractor frame components, lighting accessories, and blade or frame accessories between uses when used in combination with an FDA cleared sterilization wrap. Validated sterilization parameters include pre-vacuum steam and gravity. CYCLE CYCLE TEMP EXPOSURE TIME DRY TIME Prevacuum 132°C (270°F) 4 Minutes 30 Minutes Gravity 121°C (250°F) 30 Minutes 30 Minutes

Source page: https://510kreport.com/device/K151347
Methodology: https://510kreport.com/methodology