510(k) · Cleared
ClearedStryker Universal Select Sterilization Tray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Medical · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Apr 18, 2018 as substantially equivalent to K163279 (Medtronic Sofamor Danek USA, Inc., 2017) after a 147-day review. Its family tree reaches back 8 generations to 1984. 2 later devices descend from it.
- Decided
- Apr 18, 2018
- Review
- 147 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K844002 (1984). 14 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 6 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 5 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 4 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 3 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 2 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 1 generation backK163279 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2017
- This deviceK173615 Stryker Universal Select Sterilization Tray SystemParagon Medical · 2018
- Descendant · cites it directly · 0 of its ownK181845 Pivot System Sterilization caseRp Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK183701 Stryker ChestShield Sterilization Tray SystemParagon Medical · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −7 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −6 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −5 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −4 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −3 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −2 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −1 | K163279 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2017 | — |
| 0 (this device) | K173615 | Stryker Universal Select Sterilization Tray System | Paragon Medical | 2018 | — |
| +1 | K181845 | Pivot System Sterilization case | Rp Medical, Inc. | 2019 | — |
| +1 | K183701 | Stryker ChestShield Sterilization Tray System | Paragon Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 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 |
|---|---|---|---|
| * | K163279 | Medtronic Transportation/Sterilization CassettesSummary page 5…on Tray System is substantially equivalent to the following 510(k) cleared device: Medtronic Transportation/Sterilization Cassettes, K163279 8. Device Description: The Stryker Universal Select Sterilization Tray System consists of anodized aluminum impla… | 2017 |
| † | K792558 | Container System | 1979 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 34 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K181845 (Rp Medical, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K163279.
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. 2018, 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 Stryker Universal Select Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker Universal Select Sterilization Tray System has been validated for use in the following sterilization…
Read the full statement (290 words)
The Stryker Universal Select Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker Universal Select Sterilization Tray System has been validated for use in the following sterilization cycles:
Pre-vacuum Steam
Enclosure Rigid Container Rigid Container
Temperature 132°C (270°F) 135°C (275°F)
Sterilization Time 4 minutes 3 minutes
Minimum Dry Time 30 minutes 30 minutes
Maximum Weight 25 lbs / 11.36 kg 25 lbs / 11.36 kg
The maximum validated product loads for the trays in containers are as follows:
Configuration Maximum Validated Load Set Contents
3-Level Rack – Qty. 2 (29-13910) in a Full DIN Rigid Sterilization Container
29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941)
29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941)
29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941)
29-17901 1.7 Mid-Face Plates Module with Lid (29-13941)
29-17903 1.7 Orthognathic Plates Inlay
29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921)
29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921)
29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941)
29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941)
29-23905 2.0/2.3 Mini Plates Inlay, Large
29-13904 Mandible Fracture Instrument Tray with Lid (29-13921)
29-13905 Trocar Instrument Tray with Lid (29-13921)
3-Level Rack – Qty. 1 (29-13910) in a ½ DIN Rigid Sterilization Container
29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941)
29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941)
29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay
29-13904 Mandible Fracture Instrument Tray with Lid (29-13921)
29-13905 Trocar Instrument Tray with Lid (29-13921)
29-13906 Mandible Reconstruction Instrument Tray with Lid (29-13921)
29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173615: Stryker Universal Select Sterilization Tray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173615
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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