510(k) · Cleared
ClearedConventus PRS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conventus Orthopaedics, Inc. · HRS Plate, Fixation, Bone
Cleared on Aug 13, 2015 as substantially equivalent to K042135 (Synthes (Usa), 2004) and 2 other predicates after an 83-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Aug 13, 2015
- Review
- 83 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K962616 (1996). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
- 2 generations backK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
- 1 generation backK131552 Conventus DRSConventus Orthopaedics · 2014
- This deviceK151379 Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK161048 Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK042437 Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC · 2004
- 3 generations backK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
- 2 generations backK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
- 1 generation backK131552 Conventus DRSConventus Orthopaedics · 2014
- This deviceK151379 Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K042437 | Dorsal Intramedullary Plate | Deo Volente Orthopaedics, LLC | 2004 | — |
| −3 | K071809 | Ensplintrx Bone Fixation System | Sonoma Orthopedic Products, Inc. | 2008 | — |
| −2 | K102689 | Conventus Orthopaedics Fracture Fixation System | Conventus Orthopaedics | 2013 | — |
| −1 | K131552 | Conventus DRS | Conventus Orthopaedics | 2014 | — |
| 0 (this device) | K151379 | Conventus PRS System | Conventus Orthopaedics, Inc. | 2015 | — |
| +1 | K161048 | Conventus Orthopaedics Ulna Fixation System | Conventus Orthopaedics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K042135 | Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)Summary page 5…by the FDA: Primary predicate: Synthes T-Plate (Pre-Amendment) Synthes Elastic Intramedullary Nail System (K042135) Conventus DRS™ System (K102689 and K131552) This finding is supported… | 2004 |
| * | K102689 | Conventus Orthopaedics Fracture Fixation SystemSummary page 5…Synthes T-Plate (Pre-Amendment) Synthes Elastic Intramedullary Nail System (K042135) Conventus DRS™ System (K102689 and K131552) This finding is supported by the following pre-clinical tests that… | 2013 |
| * | K131552 | Conventus DRSSummary page 5…ate (Pre-Amendment) Synthes Elastic Intramedullary Nail System (K042135) Conventus DRS™ System (K102689 and K131552) This finding is supported by the following pre-clinical tests that have be… | 2014 |
| * | — | Synthes T-Plate Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161048 | Conventus Orthopaedics Ulna Fixation System | 2016 | 0 |
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 19 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K161048 (Conventus Orthopaedics, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K042135.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Conventus PRS™ System is indicated for treatment of proximal radial fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151379: Conventus PRS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151379
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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