510(k) · Cleared
ClearedHoffman II Micro External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 4, 2005 after a 53-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Mar 4, 2005
- Review
- 53 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK050048 Hoffman II Micro External Fixation SystemHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 2 of its ownK081244 Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK122210 Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013
- Descendant · 2 generations on · 0 of its ownK102843 Mac Male AdapterBiomet Trauma (Aka Ebi, LLC) · 2011
- Descendant · cites it directly · 0 of its ownK052498 Fragment Specific FixatorDavid J. Slutsky MD · 2005
Most influential descendants
Showing 4 of 4 · See all- K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · cites it directly2descendants
- K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013 · 2 generations on0descendants
- K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC) · 2011 · 2 generations on0descendants
- K052498Fragment Specific FixatorDavid J. Slutsky MD · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050048 | Hoffman II Micro External Fixation System | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K081244 | Lower Extremity External Fixation - Expanded Indications | Biomet Trauma | 2008 | 1 |
| +2 | K122210 | Newfix External Fixation System | Tecnologia Y Diseno Industrial, S.A DE C.V | 2013 | — |
| +2 | K102843 | Mac Male Adapter | Biomet Trauma (Aka Ebi, LLC) | 2011 | — |
| +1 | K052498 | Fragment Specific Fixator | David J. Slutsky MD | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
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?
- Of its descendants, K081244 (Biomet Trauma, 2008) has gone furthest, with 2 descendants 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?
The Hoffmann ® II Micro Tm External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
* Bone fracture fixation
* Osteotomy
* Arthrodesis
* Correction of deformity
* Revision procedure where other treatments or devices have been unsuccessful
* Non-unions and delayed unions
* Compression/distraction and lengthening
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050048: Hoffman II Micro External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050048
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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