510(k) · Cleared
ClearedReprocessed Howmedica External Fixation Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jun 24, 2002 as substantially equivalent to K802722 (Howmedica Corp., 1980) and 2 other predicates after a 315-day review. Its family tree reaches back 1 generation to 1980. 2 later devices descend from it.
- Decided
- Jun 24, 2002
- Review
- 315 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K802722 (1980). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK802722 External Fixation SystemHowmedica Corp. · 1980
- This deviceK012648 Reprocessed Howmedica External Fixation DevicesAlliance Medical Corp. · 2002
- Descendant · cites it directly · 1 of its ownK052062 Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005
- Descendant · cites it directly · 0 of its ownK153415 Reprocessed Stryker External Fixation DevicesStryker Sustainability Solutions · 2016
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 |
|---|---|---|---|---|---|
| −1 | K802722 | External Fixation System | Howmedica Corp. | 1980 | — |
| 0 (this device) | K012648 | Reprocessed Howmedica External Fixation Devices | Alliance Medical Corp. | 2002 | — |
| +1 | K052062 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | 2005 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2016 | 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 21.4 · 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? (3)
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 |
|---|---|---|---|
| * | K802722 | External Fixation SystemSummary page 2…nent Metallic Bone Fixation Appliances and Accessories Reprocessed d evicets): Predicate device(s): K802722 Extended Ball Joint with Rod Hoffmann External Fixation System… | 1980 |
| * | K930836 | Howmedica (R) Mono-Tube (TM) External Fixator SystemSummary page 2…K802722 Extended Ball Joint with Rod Hoffmann External Fixation System K930836 Howmedica Mono-TubeTM External Fixation System… | 1995 |
| * | K971755 | Hoffmann II Compact External Fixation SystemSummary page 2…K930836 Howmedica Mono-TubeTM External Fixation System K971755 Hoffmn I1 Compact External Fixation System Device description: External fixation devices are specially designed fra… | 1997 |
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?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K052062 (Alliance Medical Corp., 2005) has gone furthest, with 1 descendant of its own.
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.
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 external fixation devices are indicated for use in patients requiring external skeletal fixation oand 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/K012648 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012648: Reprocessed Howmedica External Fixation Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012648
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026