510(k) · Cleared
ClearedConventus PHS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conventus Orthopaedics, Inc. · JDS Nail, Fixation, Bone
Cleared on Apr 8, 2015 as substantially equivalent to K983853 (Depuy Ace Medical Co., 1998) and 2 other predicates after a 285-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Apr 8, 2015
- Review
- 285 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K962616 (1996). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK042437 Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC · 2004
- 2 generations backK071809 Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc. · 2008
- 1 generation backK102689 Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013
- This deviceK141737 Conventus PHS SystemConventus Orthopaedics, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K042437 | Dorsal Intramedullary Plate | Deo Volente Orthopaedics, LLC | 2004 | — |
| −2 | K071809 | Ensplintrx Bone Fixation System | Sonoma Orthopedic Products, Inc. | 2008 | — |
| −1 | K102689 | Conventus Orthopaedics Fracture Fixation System | Conventus Orthopaedics | 2013 | — |
| 0 (this device) | K141737 | Conventus PHS System | Conventus Orthopaedics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 JDS? 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 JDS device
- #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 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 |
|---|---|---|---|
| * | K983853 | Depuy Ace Timax Meta PlateSummary page 5…bstantially equivalent to the following devices that have been previously cleared by the FDA: DePuy ACE TiMAX Meta Plate (K983853) Synthes Titanium Cannulated Humeral Nail System (K033071) Conventus Orthopae… | 1998 |
| * | K033071 | Synthes (Usa) Cannulated Titanium Humeral Nail SystemSummary page 5…previously cleared by the FDA: DePuy ACE TiMAX Meta Plate (K983853) Synthes Titanium Cannulated Humeral Nail System (K033071) Conventus Orthopaedics, Inc. DRS™ System (K102689) This finding is supported by… | 2003 |
| * | K102689 | Conventus Orthopaedics Fracture Fixation SystemSummary page 5…a Plate (K983853) Synthes Titanium Cannulated Humeral Nail System (K033071) Conventus Orthopaedics, Inc. DRS™ System (K102689) This finding is supported by the following pre-clinical tests that have been perfor… | 2013 |
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 19 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 4 other devices also cite its predicate K983853.
How does its category compare?
All JDS devicesJDS Nail, 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 · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, 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 | 2 | — | 0 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Conventus Orthopaedics PHSTM System is indicated for the fixation of proximal humerus fractures except when there are too many fracture fragments to repair the articular surface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141737: Conventus PHS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141737
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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