# K102103: Skeletal Dynamics Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, LLC
- Decided: Dec 7, 2010 after 133 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: 6 generations back to K844002 (1984). 9 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 14 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 1.
- K993535: Metapak Multi-Purpose Instrument Tray, Riley Medical, Inc. (2001). Our OCR of the scanned summary read K893535, FDA’s number for Factor Vii Deficient Plasma (Medical Diagnostic Technologies, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Riley Medical, Inc. MetaPak Multi-Purpose Instrument Tray”.

## Most influential descendants
- K143579: NuVasive Sterilization Trays (2015), 3 descendants of its own
- K173391: OsteoMed QuickFix Hybrid MMF Sterilization Tray (2018), 2 descendants of its own
- K212068: Biotech Dental Kits (2021), 0 descendants of its own
- K202105: OsteoMed ExtremiFix Mini & Small System Tray (2020), 0 descendants of its own

## Indications for use
Skeletal Dynamics Sterilization Trays are intended to contain Skeletal Dynamics reusable medical devices for convenient organized storage, sterilization and transport between usages. The full Din and haif DIN trays include as accessories an insert to hold instruments and a caddy to hold implants and smaller components. The Akro-Vu tray only contains brackets to hold the Akro-Vu System’s reusable components. The full DIN and half DIN trays are suitable for use in both pre-vacuum steam and high temperature gravity steam sterilization methods. The Akro-Vu tray is suitable for use in pre-vacuum steam sterilization method. The trays are not intended to maintain sterility; they are intended to be used with a validated sterilization wrap in order to maintain the sterility of the enclosed devices. Validated Sterilization Parameters for full DIN and half DIN trays: Method Temperature Exposure Time Drying Time Pre-vacuum steam 270°F 4 minutes 20 minutes High Temperature 270°F 15 minutes 20 minutes Gravity Steam Validated Sterilization Parameters for Akro-Vu tray: Method Temperature Exposure Time Drying Time Pre-vacuum steam 270°F 4 minutes 20 minutes Device models that are the subject of this pre-market notification: Reference Description Dimensions (L x W x H) TRAY-STT-CBF1 Tray, Sterilization Full Din (Align) 19in x 9.5in x 3.6in TRAY-STT-CBH1 Tray, Sterilization Half Din (Implate) 9.7in x 9.7in x 3.6in AKR-CTR-CBC1 Tray, Sterilization Akro-Vu 15in x 12in x 4in

Source page: https://510kreport.com/device/K102103
Methodology: https://510kreport.com/methodology