510(k) · Cleared
ClearedSmith & Nephew Instrument Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Inc., Endoscopy Div. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on May 21, 2008 as substantially equivalent to K012105 (Symmetry Medical, Inc., 2002) and 1 other predicate after a 155-day review. Its family tree reaches back 4 generations to 1984. 13 later devices descend from it.
- Decided
- May 21, 2008
- Review
- 155 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K844002 (1984). 7 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 3 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 2 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 1 generation backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- This deviceK073551 Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2008
- Descendant · cites it directly · 12 of its ownK090562 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- Descendant · 2 generations on · 4 of its ownK102103 Skeletal Dynamics Sterilization TraysSkeletal Dynamics, LLC · 2010
- Descendant · cites it directly · 4 of its ownK091627 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK143579 NuVasive Sterilization TraysNu Vasive, Incorporated · 2015
- Descendant · 4 generations on · 2 of its ownK173391 OsteoMed QuickFix Hybrid MMF Sterilization TrayOsteomed, LLC · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090562Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009 · cites it directly12descendants
- K102103Skeletal Dynamics Sterilization TraysSkeletal Dynamics, LLC · 2010 · 2 generations on4descendants
- K091627Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009 · cites it directly4descendants
- K143579NuVasive Sterilization TraysNu Vasive, Incorporated · 2015 · 3 generations on3descendants
- K173391OsteoMed QuickFix Hybrid MMF Sterilization TrayOsteomed, LLC · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −3 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −2 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −1 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| 0 (this device) | K073551 | Smith & Nephew Instrument Trays | Smith & Nephew Inc., Endoscopy Div. | 2008 | — |
| +1 | K090562 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| +2 | K102103 | Skeletal Dynamics Sterilization Trays | Skeletal Dynamics, LLC | 2010 | — |
| +1 | K091627 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| +3 | K143579 | NuVasive Sterilization Trays | Nu Vasive, Incorporated | 2015 | — |
| +4 | K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | Osteomed, LLC | 2018 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K012105 | Polyvac Surgical Instrument Delivery SystemSummary page 1…ially equivalent in design, materials, and intended use to the following devices in commercial distribution: PolyVac Surgical Instrument Delivery System 510(k)# K012105 and Riley Medical, Inc. Meta-Pak Multipurpose Instrument Tray 510(k)# K993535 E. Description of Device The Smith & Nep… | 2002 |
| * | K993535 | Metapak Multi-Purpose Instrument TraySummary page 1…s in commercial distribution: PolyVac Surgical Instrument Delivery System 510(k)# K012105 and Riley Medical, Inc. Meta-Pak Multipurpose Instrument Tray 510(k)# K993535 E. Description of Device The Smith & Nephew instrument tray is designed to contain and protect reusable surgical instru… | 2001 |
What descends from it? (13)
See all 135 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 24 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K090562 (Smith & Nephew, Inc., 2009) has gone furthest, with 12 descendants of its own.
- 20 other devices also cite its predicate K012105.
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. 2008, 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 Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument tray is suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The 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…
Read the full statement (132 words)
The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument tray is suitable for use in prevacuum steam and high temperature gravity steam sterilization methods.
The 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.
Validated Sterilization Parameters:
Method: Prevacuum Steam; Temperature: 132 0C - 135 0C (270°F-275 0 F); Exposure Time: 4 minutes; Drying Time: 30 minutes.
Method: High Temperature Gravity Steam; Temperature: 132 0C (270%); Exposure Time: 10 minutes; Drying Time: 70 minutes.
Device model that is the subject of this pre-market notification: 72201731 Tray, ACUFEX° DIRECTOR ELITE ° Drill Guide Systems
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073551 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073551: Smith & Nephew Instrument Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073551
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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