510(k) · Cleared
ClearedEnsplintrx Bone Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoma Orthopedic Products, Inc. · HRS Plate, Fixation, Bone
Cleared on Feb 21, 2008 as substantially equivalent to K994061 (Wrightmedicaltechnologyinc, 2000) and 2 other predicates after a 234-day review. Its family tree reaches back 6 generations to 1996. 6 later devices descend from it.
- Decided
- Feb 21, 2008
- Review
- 234 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K962616 (1996). 10 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 4 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 3 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 1 generation backK042437 Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC · 2004
- This deviceK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
- Descendant · 2 generations on · 2 of its ownK131552 Conventus DRSConventus Orthopaedics · 2014
- Descendant · 2 generations on · 1 of its ownK151379 Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK161048 Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK141737 Conventus PHS SystemConventus Orthopaedics, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013 · cites it directly4descendants
- K131552Conventus DRSConventus Orthopaedics · 2014 · 2 generations on2descendants
- K151379Conventus PRS SystemConventus Orthopaedics, Inc. · 2015 · 2 generations on1descendant
- K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016 · 2 generations on0descendants
- K141737Conventus PHS SystemConventus Orthopaedics, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −5 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −4 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −3 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −1 | K042437 | Dorsal Intramedullary Plate | Deo Volente Orthopaedics, LLC | 2004 | — |
| 0 (this device) | K071809 | Ensplintrx Bone Fixation System | Sonoma Orthopedic Products, Inc. | 2008 | — |
| +1 | K102689 | Conventus Orthopaedics Fracture Fixation System | Conventus Orthopaedics | 2013 | — |
| +2 | K131552 | Conventus DRS | Conventus Orthopaedics | 2014 | — |
| +2 | K151379 | Conventus PRS System | Conventus Orthopaedics, Inc. | 2015 | — |
| +2 | K161048 | Conventus Orthopaedics Ulna Fixation System | Conventus Orthopaedics, Inc. | 2016 | — |
| +2 | K141737 | Conventus PHS System | Conventus Orthopaedics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K994061 | Locon-T Distal Radial PlateSummary page 1…Plate, Fixation, Bone 21 CIFR 888.3030 Predicate Device Wright Locon-T Radial Plate System K994061, cleared February 14, 2000 Wright Radial Nail System… | 2000 |
| * | K040938 | Radial Nail SystemSummary page 1…K994061, cleared February 14, 2000 Wright Radial Nail System K040938 cleared July 1, 2004 DVO Dorsal Intramedullary nail Plate… | 2004 |
| * | K042437 | Dorsal Intramedullary PlateSummary page 1…K040938 cleared July 1, 2004 DVO Dorsal Intramedullary nail Plate K(042437, cleared Ocotber 8, 2004 Description of device The EnsplintRx TMconfiguration consists of a… | 2004 |
What descends from it? (6)
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?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K102689 (Conventus Orthopaedics, 2013) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K994061.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The ENSPLINTRxTM Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: * Joint destruction and/or subluxation visible on x-ray; * Osteotomy and repair of distal radius malunion with or without bone graft; * Non-displaced fractures in which the physician and patient opt for rigid stability • Transverse fractures of the distal radius with dr without comminution (e.g. AO…
Read the full statement (143 words)
The ENSPLINTRxTM Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
* Joint destruction and/or subluxation visible on x-ray;
* Osteotomy and repair of distal radius malunion with or without bone graft;
* Non-displaced fractures in which the physician and patient opt for rigid stability
• Transverse fractures of the distal radius with dr without comminution (e.g. AO classifications A2 and A3)
* Transverse fractures of the distal radius with an extension into the joint without comminution (e.g. AO classification C 1);
* Failed fracture fixation with or without bone graft for the types of fractures above;
* The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, and C1) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071809: Ensplintrx Bone 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/K071809
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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