510(k) · Cleared
ClearedSkeletal Dynamics Sterilization Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Dynamics, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 7, 2010 as substantially equivalent to K090562 (Smith & Nephew, Inc., 2009) and 1 other predicate after a 133-day review. Its family tree reaches back 6 generations to 1984. 4 later devices descend from it.
- Decided
- Dec 7, 2010
- Review
- 133 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K844002 (1984). 9 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 4 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 3 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 2 generations backK073551 Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2008
- 1 generation backK090562 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- This deviceK102103 Skeletal Dynamics Sterilization TraysSkeletal Dynamics, LLC · 2010
- Descendant · cites it directly · 3 of its ownK143579 NuVasive Sterilization TraysNu Vasive, Incorporated · 2015
- Descendant · 2 generations on · 2 of its ownK173391 OsteoMed QuickFix Hybrid MMF Sterilization TrayOsteomed, LLC · 2018
- Descendant · 3 generations on · 0 of its ownK212068 Biotech Dental KitsBiotech Dental, Sas · 2021
- Descendant · 3 generations on · 0 of its ownK202105 OsteoMed ExtremiFix Mini & Small System TrayOsteomed, LLC · 2020
Most influential descendants
Showing 4 of 4 · See all- K143579NuVasive Sterilization TraysNu Vasive, Incorporated · 2015 · cites it directly3descendants
- K173391OsteoMed QuickFix Hybrid MMF Sterilization TrayOsteomed, LLC · 2018 · 2 generations on2descendants
- K212068Biotech Dental KitsBiotech Dental, Sas · 2021 · 3 generations on0descendants
- K202105OsteoMed ExtremiFix Mini & Small System TrayOsteomed, LLC · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −5 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −4 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −3 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −2 | K073551 | Smith & Nephew Instrument Trays | Smith & Nephew Inc., Endoscopy Div. | 2008 | — |
| −1 | K090562 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K102103 | Skeletal Dynamics Sterilization Trays | Skeletal Dynamics, LLC | 2010 | — |
| +1 | K143579 | NuVasive Sterilization Trays | Nu Vasive, Incorporated | 2015 | — |
| +2 | K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | Osteomed, LLC | 2018 | — |
| +3 | K212068 | Biotech Dental Kits | Biotech Dental, Sas | 2021 | — |
| +3 | K202105 | OsteoMed ExtremiFix Mini & Small System Tray | Osteomed, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090562 | Smith & Nephew Instrument TraysSummary page 1…me: Sterilization Cassettes, Instrument Tray, Sterilization Tray, Instrument Delivery System (Class: Class Il (KCT) Predicate Devices: Smith & Nephew Instrument Tray — K090562 ' Riley Medical, Inc. MetaPak Multi-Purpose Instrument Tray — K893535 Description of the Device: Skeletal Dynamics Sterilizatio… | 2009 |
| * | K993535 | Metapak Multi-Purpose Instrument Tray 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”. | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143579 | NuVasive Sterilization Trays | 2015 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K143579 (Nu Vasive, Incorporated, 2015) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K090562.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
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…
Read the full statement (222 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102103: Skeletal Dynamics Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102103
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026