510(k) · Cleared
Recalled · Class II · 2018Hoffmann LRF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Apr 14, 2017 as substantially equivalent to K161753 (Stryker GmbH, 2016) and 2 other predicates after a 112-day review. Its family tree reaches back 7 generations to 2000. 11 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 14, 2017
- Review
- 112 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 7 generations to K994143 (2000). 11 ancestors in all, the oldest K970748 (1997). 11 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
- 6 generations backK031181 External Fixation SystemsSmith & Nephew, Inc. · 2003
- 5 generations backK113327 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · Recalled
- 4 generations backK130334 Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013
- 3 generations backK140961 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014
- 2 generations backK153377 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · Recalled
- 1 generation backK161753 Hoffman LRF SystemStryker GmbH · 2016
- This deviceK163656 Hoffmann LRF SystemStryker GmbH · 2017
- Descendant · cites it directly · 10 of its ownK182968 Hoffmann LRF SystemStryker GmbH · 2019
- Descendant · 2 generations on · 8 of its ownK203568 Hoffmann LRF SystemStryker GmbH · 2021
- Descendant · 3 generations on · 5 of its ownK212895 Paragon 28 External Ring Fixation SystemParagon 28, Inc. · 2021
- Descendant · 4 generations on · 3 of its ownK232838 Monkey RingsTM External Fixation SystemParagon 28, Inc. · 2023
- Descendant · 5 generations on · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K182968Hoffmann LRF SystemStryker GmbH · 2019 · cites it directly10descendants
- K203568Hoffmann LRF SystemStryker GmbH · 2021 · 2 generations on8descendants
- K212895Paragon 28 External Ring Fixation SystemParagon 28, Inc. · 2021 · 3 generations on5descendants
- K232838Monkey RingsTM External Fixation SystemParagon 28, Inc. · 2023 · 4 generations on3descendants
- K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… | Smith & Nephew, Inc. | 2000 | 19 |
| −6 | K031181 | External Fixation Systems | Smith & Nephew, Inc. | 2003 | — |
| −5 | K113327 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Corp. | 2012 | 3 |
| −4 | K130334 | Hoffmann LRF (Limb Reconstruction Frame System) | Stryker Trauma AG | 2013 | — |
| −3 | K140961 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Trauma AG | 2014 | — |
| −2 | K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker GmbH | 2016 | 2 |
| −1 | K161753 | Hoffman LRF System | Stryker GmbH | 2016 | — |
| 0 (this device) | K163656 | Hoffmann LRF System | Stryker GmbH | 2017 | — |
| +1 | K182968 | Hoffmann LRF System | Stryker GmbH | 2019 | — |
| +2 | K203568 | Hoffmann LRF System | Stryker GmbH | 2021 | — |
| +3 | K212895 | Paragon 28 External Ring Fixation System | Paragon 28, Inc. | 2021 | — |
| +4 | K232838 | Monkey RingsTM External Fixation System | Paragon 28, Inc. | 2023 | — |
| +5 | K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K161753 | Hoffman LRF SystemSummary page 4…accessories (21 CFR § 888.3030) Regulatory Class: Class II Product Code: KTT Primary Predicate: Hoffmann LRF System, K161753 Additional Predicates: Taylor Spatial Frame External Fixation System, K970748 External Fi… | 2016 |
| * | K970748 | Taylor Spatial Frame External Fixation SystemSummary page 4…ct Code: KTT Primary Predicate: Hoffmann LRF System, K161753 Additional Predicates: Taylor Spatial Frame External Fixation System, K970748 External Fixation System (Ilizarov), K031181 System Description: The Hoffmann LRF System is a m… | 1997 |
| * | K031181 | External Fixation SystemsSummary page 4…ystem, K161753 Additional Predicates: Taylor Spatial Frame External Fixation System, K970748 External Fixation System (Ilizarov), K031181 System Description: The Hoffmann LRF System is a modular, ring-based, external fixation system designed to address certain ort… | 2003 |
What descends from it? (11)
See all 112 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 |
|---|---|---|---|---|
| Aug 28, 2018 | Class II | Z-0289-2019 | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in… |
| Aug 28, 2018 | Class II | Z-0290-2019 | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in… |
| Aug 28, 2018 | Class II | Z-0291-2019 | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in… |
| Aug 28, 2018 | Class II | Z-0288-2019 | Under Investigation by firm | The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in… |
| Jul 26, 2018 | Class II | Z-3240-2018 | Under Investigation by firm | When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K182968 (Stryker GmbH, 2019) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K161753.
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. 2017, 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 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, diaphyseal, or…
Read the full statement (146 words)
The Stryker Hoffmann LRF 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, diaphyseal, 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
• Bone transport
The 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 as stated in the FDA summary.
https://510kreport.com/device/K163656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163656: Hoffmann LRF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163656
Report an extraction error
Are you the manufacturer?
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