510(k) · Cleared
ClearedHoffmann LRF (Limb Reconstruction Frame) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma AG · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 10, 2014 as substantially equivalent to K113327 (Stryker Corp., 2012) and 3 other predicates after a 209-day review. Its family tree reaches back 4 generations to 2000. 14 later devices descend from it.
- Decided
- Nov 10, 2014
- Review
- 209 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K994143 (2000). 7 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
- 3 generations backK031181 External Fixation SystemsSmith & Nephew, Inc. · 2003
- 2 generations backK113327 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · Recalled
- 1 generation backK130334 Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013
- This deviceK140961 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014
- Descendant · cites it directly · 13 of its ownK153377 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · Recalled
- Descendant · 2 generations on · 12 of its ownK161753 Hoffman LRF SystemStryker GmbH · 2016
- Descendant · 3 generations on · 11 of its ownK163656 Hoffmann LRF SystemStryker GmbH · 2017 · Recalled
- Descendant · 4 generations on · 10 of its ownK182968 Hoffmann LRF SystemStryker GmbH · 2019
- Descendant · 5 generations on · 8 of its ownK203568 Hoffmann LRF SystemStryker GmbH · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · cites it directly13descendants
- K161753Hoffman LRF SystemStryker GmbH · 2016 · 2 generations on12descendants
- K163656Hoffmann LRF SystemStryker GmbH · 2017 · 3 generations on11descendants
- K182968Hoffmann LRF SystemStryker GmbH · 2019 · 4 generations on10descendants
- K203568Hoffmann LRF SystemStryker GmbH · 2021 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… | Smith & Nephew, Inc. | 2000 | 19 |
| −3 | K031181 | External Fixation Systems | Smith & Nephew, Inc. | 2003 | — |
| −2 | K113327 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Corp. | 2012 | 3 |
| −1 | K130334 | Hoffmann LRF (Limb Reconstruction Frame System) | Stryker Trauma AG | 2013 | — |
| 0 (this device) | K140961 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Trauma AG | 2014 | — |
| +1 | K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker GmbH | 2016 | 2 |
| +2 | K161753 | Hoffman LRF System | Stryker GmbH | 2016 | — |
| +3 | K163656 | Hoffmann LRF System | Stryker GmbH | 2017 | 5 |
| +4 | K182968 | Hoffmann LRF System | Stryker GmbH | 2019 | — |
| +5 | K203568 | Hoffmann LRF System | Stryker GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K113327 | Hoffmann LRF (Limb Reconstruction Frame) SystemSummary page 5…32 641 66 60 [email protected] Date Prepared: April 10, 2014 Description: Originally cleared in K113327, the Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, a… | 2012 |
| * | K130334 | Hoffmann LRF (Limb Reconstruction Frame System)Summary page 5…telescopic strut and wire bolt components, as part of the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327, were cleared in K130334. • Additional components (carbon foot ring, foot arch, hinge coupling) were cleared in K130907 as a line extension to… | 2013 |
| * | K130907 | Hoffmann LRF (Limb Reconstruction Frame) SystemSummary page 5…construction Frame) System in K113327, were cleared in K130334. • Additional components (carbon foot ring, foot arch, hinge coupling) were cleared in K130907 as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327. • This Trad… | 2013 |
| * | K031181 | External Fixation SystemsSummary page 6…o the following predicate devices: • Hoffmann LRF (Limb Reconstruction Frame) System- K113327/ K130334/ K130907 • External Fixation System (Smith and Nephew)- K031181 Non-Clinical Testing: Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on t… | 2003 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | 2016 | 13 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K153377 (Stryker GmbH, 2016) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K113327.
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. 2014, 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?
The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of: Open and Closed Fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis or non-union of long bones Limb lengthening by epiphyseal or…
Read the full statement (131 words)
The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:
Open and Closed Fractures
Post-traumatic joint contracture which has resulted in loss of range of motion
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Pseudoarthrosis or non-union of long bones
Limb lengthening by epiphyseal or metaphyseal distraction
Correction of bony or soft tissue deformity
Correction of segmental bony or soft tissue defects
Joint arthrodesis
Management of comminuted intra-articular fractures of the distal radius
The Stryker Hoffmann LRF System is indicated in adults for:
Osteotomy
Revision procedure where other treatments or devices have been unsuccessful
Bone reconstruction procedures
Fusions and replantations of the foot
Charcot foot reconstruction
Lisfranc dislocations
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140961: Hoffmann LRF (Limb Reconstruction Frame) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140961
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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