510(k) · Cleared
ClearedOsteoMed ExtremiFix Mini & Small System Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Oct 29, 2020 as substantially equivalent to K173391 (Osteomed, LLC, 2018) after a 92-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- Oct 29, 2020
- Review
- 92 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K844002 (1984). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations between
- 3 generations backK102103 Skeletal Dynamics Sterilization TraysSkeletal Dynamics, LLC · 2010
- 2 generations backK143579 NuVasive Sterilization TraysNu Vasive, Incorporated · 2015
- 1 generation backK173391 OsteoMed QuickFix Hybrid MMF Sterilization TrayOsteomed, LLC · 2018
- This deviceK202105 OsteoMed ExtremiFix Mini & Small System TrayOsteomed, LLC · 2020
Show all 9 generations
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 8 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 7 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 6 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 5 generations backK073551 Smith & Nephew Instrument TraysSmith & Nephew Inc., Endoscopy Div. · 2008
- 4 generations backK090562 Smith & Nephew Instrument TraysSmith & Nephew, Inc. · 2009
- 3 generations backK102103 Skeletal Dynamics Sterilization TraysSkeletal Dynamics, LLC · 2010
- 2 generations backK143579 NuVasive Sterilization TraysNu Vasive, Incorporated · 2015
- 1 generation backK173391 OsteoMed QuickFix Hybrid MMF Sterilization TrayOsteomed, LLC · 2018
- This deviceK202105 OsteoMed ExtremiFix Mini & Small System TrayOsteomed, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −8 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −7 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −6 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −5 | K073551 | Smith & Nephew Instrument Trays | Smith & Nephew Inc., Endoscopy Div. | 2008 | — |
| −4 | K090562 | Smith & Nephew Instrument Trays | Smith & Nephew, Inc. | 2009 | — |
| −3 | K102103 | Skeletal Dynamics Sterilization Trays | Skeletal Dynamics, LLC | 2010 | — |
| −2 | K143579 | NuVasive Sterilization Trays | Nu Vasive, Incorporated | 2015 | — |
| −1 | K173391 | OsteoMed QuickFix Hybrid MMF Sterilization Tray | Osteomed, LLC | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K173391 | OsteoMed QuickFix Hybrid MMF Sterilization TraySummary page 4…Regulation: 880.6850 Regulatory Class: II Product Code: KCT III. PREDICATE DEVICE Predicate Device: OsteoMed MMF Sterilization Tray (K173391) Reference Device: NuVasive Sterilization Tray (K143579) IV. DEVICE DESCRIPTION The OsteoMed ExtremiFix M… | 2018 |
| † | K143579 | NuVasive Sterilization Trays | 2015 |
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 36 years and passes through 9 companies; a new generation was cleared every 2.7 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K173391.
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. 2020, 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 OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The system tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed…
Read the full statement (184 words)
The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The system tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The System Tray may also be used in conjunction with a legally marketed rigid container.
Sterilization validation was performed utilizing the ExtremiFix Mini & Small Cannulated Screw System implants and accessories such as surgical instrumentation. Do not exceed a maximum load of 14.1 lbs. in the sterilization system tray.
Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a wrapped configuration:
Method: Steam Cycle
Pre-Vacuum Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 50 minutes
Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a rigid container configuration:
Method: Steam Cycle
Pre-Vacuum Temperature: 270°F (132°C)
Exposure Time: 4 minutes
Minimum Dry Time: 30 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202105: OsteoMed ExtremiFix Mini & Small System Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202105
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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