# K243128: Klockner Kits

- Pathway: 510(k) (Traditional)
- Applicant: Soadco, S.L.
- Decided: Dec 18, 2024 after 79 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173642: Klockner Surgical Box, Soadco, S.L. (2018) Summary page 7.

## Indications for use
Indications for Use for the KIT WT SNIPER KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT SNIPER and the associated instruments is 820 grams. The weight of the empty KIT WT SNIPER is 620 grams. The KIT WT SNIPER is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT WT SNIPER JSI KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT SNIPER JSI and the associated instruments is 920 grams. The weight of the empty KIT WT SNIPER JSI is 620 grams. The KIT WT SNIPER JSI is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE 1.5 families and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT WT INTERNA KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT INTERNA and the associated instruments is 840 grams. The weight of the empty KIT WT INTERNA is 620 grams. The KIT WT INTERNA is exclusively indicated to assist in the installation of implants of both the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT WT VEGA KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT VEGA and the associated instruments is 820 grams. The weight of the empty KIT WT VEGA is 620 grams. The KIT WT VEGA is exclusively indicated to assist in the installation of implants of the VEGA® family and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT WT ESSENTIAL KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT WT ESSENTIAL and the associated instruments is 800 grams. The weight of the empty KIT WT ESSENTIAL is 620 grams. The KIT WT ESSENTIAL is exclusively indicated to assist in the installation of implants of the ESSENTIAL® CONE family and is not compatible with other lines and systems of other manufacturers. Indications for Use for the KIT MEDGUIDE® KLOCKNER KITS are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. KLOCKNER KITS are intended to allow sterilization of the enclosed medical devices. KLOCKNER KITS require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Dynamic air removal steam sterilization – Exposure at 134 °C for 4 minutes and 16 minutes dry time. KLOCKNER KITS are intended for sterilization of non-porous loads. KLOCKNER KITS are recommended not to be stacked during sterilization. The combined weight of the KIT MEDGUIDE® and the associated instruments is 240 grams. The weight of the empty KIT MEDGUIDE® is 160 grams. The KIT MEDGUIDE® is exclusively indicated to assist in the installation of implants of the VEGA® and ESSENTIAL® CONE families and is not compatible with other lines and systems of other manufacturers.

Source page: https://510kreport.com/device/K243128
Methodology: https://510kreport.com/methodology