510(k) · Cleared
ClearedNuVasive Sterilization Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 28, 2015 as substantially equivalent to K102103 (Skeletal Dynamics, LLC, 2010) after a 253-day review. Its family tree reaches back 7 generations to 1984. 3 later devices descend from it.
- Decided
- Aug 28, 2015
- Review
- 253 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K844002 (1984). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 5 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 4 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 3 generations backK073551 Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2008
- 2 generations backK090562 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- 1 generation backK102103 Skeletal Dynamics Sterilization TraysSkeletal Dynamics, LLC · 2010
- This deviceK143579 NuVasive Sterilization TraysNu Vasive, Incorporated · 2015
- Descendant · cites it directly · 2 of its ownK173391 OsteoMed QuickFix Hybrid MMF Sterilization TrayOsteomed, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK212068 Biotech Dental KitsBiotech Dental, Sas · 2021
- Descendant · 2 generations on · 0 of its ownK202105 OsteoMed ExtremiFix Mini & Small System TrayOsteomed, LLC · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −6 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −5 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −4 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −3 | K073551 | Smith & Nephew Instrument Trays | Smith & Nephew Inc., Endoscopy Div. | 2008 | — |
| −2 | K090562 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| −1 | K102103 | Skeletal Dynamics Sterilization Trays | Skeletal Dynamics, LLC | 2010 | — |
| 0 (this device) | K143579 | NuVasive Sterilization Trays | Nu Vasive, Incorporated | 2015 | — |
| +1 | K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | Osteomed, LLC | 2018 | — |
| +2 | K212068 | Biotech Dental Kits | Biotech Dental, Sas | 2021 | — |
| +2 | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K102103 | Skeletal Dynamics Sterilization TraysSummary page 7…Predicate Devices The subject NuVasive Sterilization Trays are substantially equivalent to the primary predicate device, Skeletal Dynamics Sterilization Trays (K102103). D. Device Description The NuVasive Sterilization Trays are designed to contain NuVasive implants and instruments f… | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | 2018 | 2 |
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 31 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K173391 (Osteomed, LLC, 2018) has gone furthest, with 2 descendants of its own.
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. 2015, 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?
The NuVasive Sterilization Trays are intended to contain NuVasive implants and surgical instruments for sterilization, storage and handling. The NuVasive Sterilization Trays are suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices.…
Read the full statement (175 words)
The NuVasive Sterilization Trays are intended to contain NuVasive implants and surgical instruments for sterilization, storage and handling. The NuVasive Sterilization Trays are suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices.
Sterilization validations for three level worst case tray (20.5" x 10" x 7.375") included three different loading configurations: implant only content (26.4 Ibs.), instrument only content (39.95 1bs.) and mixed instruments and implants content (30.45 lbs.)
Validated worst case loading configurations included 23 instruments with lumens including the following worst case lumen dimensions:
- 1.6 mm x 306.8 mm
- 1.1 mmx 166.4 mm
-7.2mmx 331.9 mm
-5.5mmx 356.9 mm
Do not exceed a maximum load of 25 1bs in the sterilization tray.
Validated sterilization parameters for NuVasive Sterilization Trays:
Method: Steam
Cycle: Pre-Vacuum
Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Minimum Cool Down Time: 40 minutes
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/K143579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143579: NuVasive Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143579
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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