510(k) · Cleared
ClearedHoffmann 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 Dec 19, 2025 as substantially equivalent to K233741 (Stryker GmbH, 2023) and 6 other predicates after an 84-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Dec 19, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K962616 (1996). 91 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK191241 AutoStrutOrthospin · 2019
- 2 generations backK202810 AutoStrut G2Orthospin, Ltd. · 2021
- 1 generation backK231922 DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes · 2023
- This deviceK253202 Hoffmann LRF SystemStryker GmbH · 2025
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- 4 generations backK161417 DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC · 2016
- 3 generations backK191241 AutoStrutOrthospin · 2019
- 2 generations backK202810 AutoStrut G2Orthospin, Ltd. · 2021
- 1 generation backK231922 DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes · 2023
- This deviceK253202 Hoffmann LRF SystemStryker GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| −4 | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | Synthes USA, LLC | 2016 | — |
| −3 | K191241 | AutoStrut | Orthospin | 2019 | — |
| −2 | K202810 | AutoStrut G2 | Orthospin, Ltd. | 2021 | — |
| −1 | K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | DePuy Synthes | 2023 | — |
| 0 (this device) | K253202 | Hoffmann LRF System | Stryker GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 8 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 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? (7)
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 |
|---|---|---|---|
| * | K233741 | Hoffmann LRF SystemSummary page 5…one fixation fastener (21 CFR § 888.3040) Regulatory Class: Class II Primary Predicate: Hoffmann LRF System (K233741) Additional Predicates: Stryker Apex Pins (K061493) Stryker RingFix (K071394)… | 2023 |
| * | K061493 | Apex PinsSummary page 5…R § 888.3040) Regulatory Class: Class II Primary Predicate: Hoffmann LRF System (K233741) Additional Predicates: Stryker Apex Pins (K061493) Stryker RingFix (K071394) S&N Taylor Spatial Frame (K210953)… | 2006 |
| * | K071394 | Modification to:Sbi RingfixSummary page 5…Primary Predicate: Hoffmann LRF System (K233741) Additional Predicates: Stryker Apex Pins (K061493) Stryker RingFix (K071394) S&N Taylor Spatial Frame (K210953) Depuy Synthes MAXFRAME (K211313… | 2007 |
| * | K210953 | SMART Taylor Spatial FrameSummary page 5…itional Predicates: Stryker Apex Pins (K061493) Stryker RingFix (K071394) S&N Taylor Spatial Frame (K210953) Depuy Synthes MAXFRAME (K211313) Depuy Synthes MAXFRAME AUTOSTRUT… | 2021 |
| * | K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Summary page 5…Stryker RingFix (K071394) S&N Taylor Spatial Frame (K210953) Depuy Synthes MAXFRAME (K211313) Depuy Synthes MAXFRAME AUTOSTRUT (K231922) S&N Ilizarov Frame (K20… | 2021 |
| * | K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemSummary page 5…S&N Taylor Spatial Frame (K210953) Depuy Synthes MAXFRAME (K211313) Depuy Synthes MAXFRAME AUTOSTRUT (K231922) S&N Ilizarov Frame (K201353) System Description: The Hoffmann LRF System is a modular, ring-base… | 2023 |
| * | K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV… Our reading of the summary gave K201353, FDA’s number for CenterMed Patient Matched Assisted Surgical Planning (ASP)… (Centermed, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “S&N Ilizarov Frame”. | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 9 companies; a new generation was cleared every 2.1 years on median.
- 23 of the 91 ancestors have a recall of any class.
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. 2025, 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 (2 through 21 years of age) and adult patients 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…
Read the full statement (152 words)
The Stryker Hoffmann LRF System is indicated in pediatric (2 through 21 years of age) and adult patients 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/K253202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253202: 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/K253202
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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