# K102544: Smith & Nephew Hip Arthroscopy Repair Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Inc., Endoscopy Div.
- Decided: Jan 5, 2011 after 124 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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: 7 generations back to K844002 (1984). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090562: Smith & Nephew Instrument Trays, Smith & Nephew, Inc. (2009) Summary page 2.
- K091627: Smith & Nephew Instrument Trays, Smith & Nephew, Inc. (2009) Summary page 2.

## Recalls of this device
- May 19, 2011 · Not classified · Z-2646-2011: Hip Arthroscopy Repair Instrument Tray shipped with an incorrect Instructions For Use (IFU)

## Indications for use
Smith & Nephew Hip Arthroscopy Repair Instrument Tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The subject instrument tray is suitable for use in a pre-vacuum steam sterilization method. The subject instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices.

Source page: https://510kreport.com/device/K102544
Methodology: https://510kreport.com/methodology