510(k) · Cleared
ClearedConventus Orthopaedics Fracture Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conventus Orthopaedics · HRS Plate, Fixation, Bone
Cleared on Jan 17, 2013 as substantially equivalent to K071809 (Sonoma Orthopedic Products, Inc., 2008) and 1 other predicate after an 853-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it.
- Decided
- Jan 17, 2013
- Review
- 853 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962616 (1996). 11 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 2 generations backK042437 Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC · 2004
- 1 generation backK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
- This deviceK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
- Descendant · cites it directly · 2 of its ownK131552 Conventus DRSConventus Orthopaedics · 2014
- Descendant · cites it directly · 1 of its ownK151379 Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK161048 Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK141737 Conventus PHS SystemConventus Orthopaedics, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K131552Conventus DRSConventus Orthopaedics · 2014 · cites it directly2descendants
- K151379Conventus PRS SystemConventus Orthopaedics, Inc. · 2015 · cites it directly1descendant
- K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016 · cites it directly0descendants
- K141737Conventus PHS SystemConventus Orthopaedics, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −4 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −2 | K042437 | Dorsal Intramedullary Plate | Deo Volente Orthopaedics, LLC | 2004 | — |
| −1 | K071809 | Ensplintrx Bone Fixation System | Sonoma Orthopedic Products, Inc. | 2008 | — |
| 0 (this device) | K102689 | Conventus Orthopaedics Fracture Fixation System | Conventus Orthopaedics | 2013 | — |
| +1 | K131552 | Conventus DRS | Conventus Orthopaedics | 2014 | — |
| +1 | K151379 | Conventus PRS System | Conventus Orthopaedics, Inc. | 2015 | — |
| +1 | K161048 | Conventus Orthopaedics Ulna Fixation System | Conventus Orthopaedics, Inc. | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K071809 | Ensplintrx Bone Fixation SystemSummary page 2…Plate (Pre-amendment device), Sonoma Orthopedic Products EnsplintRXTM Intramedullary Distal Radius Fixation Device (K07 1809), Wright Radial Nail System (MICRONAIL®R) (K04093 8). Like the identified p… | 2008 |
| * | K040938 | Radial Nail SystemSummary page 2…ucts EnsplintRXTM Intramedullary Distal Radius Fixation Device (K07 1809), Wright Radial Nail System (MICRONAIL®R) (K04093 8). Like the identified predicates, the Conventus DRSTM can capture distal ra… | 2004 |
| * | — | Synthes T-Plate (Pre-amendment device) Named without a submission number |
What descends from it? (4)
4 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 17 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K131552 (Conventus Orthopaedics, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K071809.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 DRSTM is intended for the fixation of distal radius fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102689 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102689: Conventus Orthopaedics Fracture 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/K102689
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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