510(k) · Cleared
ClearedReprocessed Stryker External Fixation Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Sustainability Solutions · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 13, 2016 as substantially equivalent to K052062 (Alliance Medical Corp., 2005) and 1 other predicate after a 49-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Jan 13, 2016
- Review
- 49 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K802722 (1980). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK802722 External Fixation SystemHowmedica Corp. · 1980
- 2 generations backK012648 Reprocessed Howmedica External Fixation DevicesAlliance Medical Corp. · 2002
- 1 generation backK052062 Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005
- This deviceK153415 Reprocessed Stryker External Fixation DevicesStryker Sustainability Solutions · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K802722 | External Fixation System | Howmedica Corp. | 1980 | — |
| −2 | K012648 | Reprocessed Howmedica External Fixation Devices | Alliance Medical Corp. | 2002 | — |
| −1 | K052062 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | 2005 | — |
| 0 (this device) | K153415 | Reprocessed Stryker External Fixation Devices | Stryker Sustainability Solutions | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 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 |
|---|---|---|---|
| * | K052062 | Alliance Medical Corporation Reprocessed External Fixation DevicesSummary page 5…ion Devices Page 1 of 3 PREDICATE DEVICES: 510(k) Number 510(k) Title Original Manufacturer K052062 – Modification to Reprocessed Howmedica Alliance Medical Corporation Primary External Fixation Devi… | 2005 |
| * | K012648 | Reprocessed Howmedica External Fixation DevicesSummary page 5…Manufacturer K052062 – Modification to Reprocessed Howmedica Alliance Medical Corporation Primary External Fixation Devices [Non-Sterile] K012648 - Reprocessed Howmedica External Fixation Alliance Medical Corporation Secondary Devices [Sterile] Tab… | 2002 |
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 3 companies; a new generation was cleared every 10.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
Reprocessed Stryker External Fixation Devices are indicated for use in patients requiring external fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153415: Reprocessed Stryker External Fixation Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153415
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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