510(k) · Cleared
ClearedVersitomic Acl Flexible Reamer System Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tag Medical Products · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Aug 9, 2010 as substantially equivalent to K032119 (Paragon Medical, Inc., 2003) after a 132-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Aug 9, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K844002 (1984). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 4 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 3 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 2 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 1 generation backK032119 Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc. · 2003
- This deviceK100887 Versitomic Acl Flexible Reamer System Sterilization TrayTag Medical Products · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −4 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −3 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −2 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −1 | K032119 | Paragon Medical Surgical Instrument Delivery System Various | Paragon Medical, Inc. | 2003 | — |
| 0 (this device) | K100887 | Versitomic Acl Flexible Reamer System Sterilization Tray | Tag Medical Products | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K032119 | Paragon Medical Surgical Instrument Delivery System VariousSummary page 1…Name: VersiTomic ThACL Flexible Reamer System Sterilization Tray 3. Predicate Device: Paragon Medical Surgical Instrumentation Delivery System (K0321 19) 4. Description: The VersiTomic mACL Flexible Reamer System Sterilization Tray is a reusab… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K032119.
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?
The VersiTomicTm ACL Flexible Reamer System Sterilization Tray is indicated to enclose the VersiTomnic ACL Flexible Reamer System instruments that are to be sterilized by a health care provider. The Sterilization Tray consists of an interlocking tray and lid, which are both perforated to allow the passage of the sterilizing agent from outside the tray to the devices placed inside. The VersiTomicTm ACL Flexible Reamer System Sterilization tray has been…
Read the full statement (178 words)
The VersiTomicTm ACL Flexible Reamer System Sterilization Tray is indicated to enclose the VersiTomnic ACL Flexible Reamer System instruments that are to be sterilized by a health care provider.
The Sterilization Tray consists of an interlocking tray and lid, which are both perforated to allow the passage of the sterilizing agent from outside the tray to the devices placed inside.
The VersiTomicTm ACL Flexible Reamer System Sterilization tray has been validated with a load that consists of various metallic instruments and implants up to a length of 340 mm and minimum internal diameter of 1.4 mm. The maximum load is 9.6 kg (21.1 lb) which is distributed equally within the tray.
The VersiTomiCTm ACL Flexible Reamer System Sterilization Tray has been validated for steam sterilization using the following parameters:
Gravity-Displacement Steam Sterilization
* Sterilizer Type: Gravity
* Minimum Temperature: 1320C (2700 F)
* Minimum Exposure Time: 10 minutes
* Minimum Dry Time: 40 minutes
Pre-Vacuum Steam Sterilization
*Sterilizer Type: Pre-Vacuum
* Minimum Temperature: 13200 (2700 F)
* Minimum Exposure Time: 4 minutes
* Minimum Dry Time: 15 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100887: Versitomic Acl Flexible Reamer System Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100887
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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