510(k) · Cleared
ClearedConventus Orthopaedics Ulna Fixation 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 Jul 26, 2016 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 4 other predicates after a 103-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Jul 26, 2016
- Review
- 103 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K962616 (1996). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
- 2 generations backK131552 Conventus DRSConventus Orthopaedics · 2014
- 1 generation backK151379 Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
- This deviceK161048 Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK042437 Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC · 2004
- 4 generations backK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
- 3 generations backK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
- 2 generations backK131552 Conventus DRSConventus Orthopaedics · 2014
- 1 generation backK151379 Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
- This deviceK161048 Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K042437 | Dorsal Intramedullary Plate | Deo Volente Orthopaedics, LLC | 2004 | — |
| −4 | K071809 | Ensplintrx Bone Fixation System | Sonoma Orthopedic Products, Inc. | 2008 | — |
| −3 | K102689 | Conventus Orthopaedics Fracture Fixation System | Conventus Orthopaedics | 2013 | — |
| −2 | K131552 | Conventus DRS | Conventus Orthopaedics | 2014 | — |
| −1 | K151379 | Conventus PRS System | Conventus Orthopaedics, Inc. | 2015 | — |
| 0 (this device) | 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 | 3 | 0 |
| 2004 | 2 | 0 |
| 2008 | 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? (5)
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 |
|---|---|---|---|
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 5…cleared by the FDA: • Primary predicate: Synthes T-Plate (Small Fragment Dynamic Compression Locking System) (K000684) • Synthes Olecranon Osteotomy Nailing System (K073402) • Conventus DRS™… | 2000 |
| * | K073402 | Synthes Olecranon Osteotomy Nailing SystemSummary page 5…te (Small Fragment Dynamic Compression Locking System) (K000684) • Synthes Olecranon Osteotomy Nailing System (K073402) • Conventus DRS™ System (K102689, K131552) • Conventus PRS™ System (K151… | 2008 |
| * | K102689 | Conventus Orthopaedics Fracture Fixation SystemSummary page 5…ression Locking System) (K000684) • Synthes Olecranon Osteotomy Nailing System (K073402) • Conventus DRS™ System (K102689, K131552) • Conventus PRS™ System (K151379) This finding is supported by t… | 2013 |
| * | K131552 | Conventus DRSSummary page 5…ocking System) (K000684) • Synthes Olecranon Osteotomy Nailing System (K073402) • Conventus DRS™ System (K102689, K131552) • Conventus PRS™ System (K151379) This finding is supported by the follow… | 2014 |
| * | K151379 | Conventus PRS SystemSummary page 5…Olecranon Osteotomy Nailing System (K073402) • Conventus DRS™ System (K102689, K131552) • Conventus PRS™ System (K151379) This finding is supported by the following pre-clinical tests that have be… | 2015 |
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 20 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 68 other devices also cite its predicate K000684.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Orthopaedics Ulna Fixation System is indicated for treatment of distal or proximal ulna 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161048: Conventus Orthopaedics Ulna 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/K161048
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