510(k) · Cleared
Recalled · Class II · 2018Hoffmann LRF (Limb Reconstruction Frame) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 29, 2012 as substantially equivalent to K031181 (Smith & Nephew, Inc., 2003) and 2 other predicates after a 140-day review. Its family tree reaches back 2 generations to 2000. 17 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 29, 2012
- Review
- 140 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K994143 (2000). 4 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
- 1 generation backK031181 External Fixation SystemsSmith & Nephew, Inc. · 2003
- This deviceK113327 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012
- Descendant · cites it directly · 15 of its ownK130907 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2013
- Descendant · cites it directly · 15 of its ownK130334 Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013
- Descendant · cites it directly · 14 of its ownK140961 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014
- Descendant · 2 generations on · 13 of its ownK153377 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · Recalled
- Descendant · 3 generations on · 12 of its ownK161753 Hoffman LRF SystemStryker GmbH · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K130907Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2013 · cites it directly15descendants
- K130334Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013 · cites it directly15descendants
- K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014 · cites it directly14descendants
- K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · 2 generations on13descendants
- K161753Hoffman LRF SystemStryker GmbH · 2016 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… | Smith & Nephew, Inc. | 2000 | 19 |
| −1 | K031181 | External Fixation Systems | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | K113327 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Corp. | 2012 | — |
| +1 | K130907 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Trauma AG | 2013 | — |
| +1 | K130334 | Hoffmann LRF (Limb Reconstruction Frame System) | Stryker Trauma AG | 2013 | — |
| +1 | K140961 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Trauma AG | 2014 | — |
| +2 | K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker GmbH | 2016 | 2 |
| +3 | K161753 | Hoffman LRF System | Stryker GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K031181 | External Fixation SystemsSummary page 2…parison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices: " K03 1181 External Fixation Systems (Smith & Nephew) * K04 1706 Hoffman 11 Foot Ring * K003018 Titan Tibial Nail (T2 Nail) Non-Clini… | 2003 |
| * | K041706 | Hoffmann II Foot RingSummary page 2…equivalent in intended, use, materials and performance characteristics to the following predicate devices: " K03 1181 External Fixation Systems (Smith & Nephew) * K04 1706 Hoffman 11 Foot Ring * K003018 Titan Tibial Nail (T2 Nail) Non-Clinical Testing: Non-clinical laboratory testing was performe… | 2004 |
| * | K003018 | Titan Tibial NailSummary page 2…als and performance characteristics to the following predicate devices: " K03 1181 External Fixation Systems (Smith & Nephew) * K04 1706 Hoffman 11 Foot Ring * K003018 Titan Tibial Nail (T2 Nail) Non-Clinical Testing: Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Recon… | 2000 |
What descends from it? (17)
See all 173 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 12, 2018 | Class II | Z-1526-2018 | Labeling mix-ups | The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling |
| Oct 25, 2012 | Class II | Z-0695-2013 | Device Design | Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients. |
| Jul 3, 2012 | Class II | Z-0266-2013 | Device Design | Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K130907 (Stryker Trauma AG, 2013) has gone furthest, with 15 descendants of its own.
- 8 other devices also cite its predicate K031181.
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. 2012, 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 bo~nes 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 bo~nes
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
Lisfiranc dislocations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113327: 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/K113327
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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