510(k) · Cleared
ClearedAcumed Wrist Spanning Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumed, LLC · HRS Plate, Fixation, Bone
Cleared on Sep 5, 2013 as substantially equivalent to K082807 (Synthes (Usa), 2008) after an 80-day review. Its family tree reaches back 4 generations to 1998. 7 later devices descend from it.
- Decided
- Sep 5, 2013
- Review
- 80 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981372 (1998). 12 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- This deviceK131764 Acumed Wrist Spanning PlateAcumed, LLC · 2013
- Descendant · cites it directly · 2 of its ownK191848 APTUS Wrist Spanning Plates 2.5Medartis AG · 2019
- Descendant · cites it directly · 1 of its ownK251132 The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation…Acumed, LLC · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK243308 Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal…Bonebridge AG · 2024
- Descendant · 3 generations on · 0 of its ownK261351 SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026
- Descendant · 2 generations on · 0 of its ownK252356 The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191848APTUS Wrist Spanning Plates 2.5Medartis AG · 2019 · cites it directly2descendants
- K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC · 2025 · cites it directly1descendant
- K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG · 2024 · 2 generations on1descendant
- K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026 · 3 generations on0descendants
- K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −3 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −2 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −1 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| 0 (this device) | K131764 | Acumed Wrist Spanning Plate | Acumed, LLC | 2013 | — |
| +1 | K191848 | APTUS Wrist Spanning Plates 2.5 | Medartis AG | 2019 | — |
| +1 | K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System -… | Acumed, LLC | 2025 | 1 |
| +2 | K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System… | Bonebridge AG | 2024 | — |
| +3 | K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026 | — |
| +2 | K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | Acumed, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 2…usions, as well as the detailed test reports can be found in Section 36. Legally Marketed Predicate Device: Synthes 3.5mm Locking Compression Plate standard bone plate (K082807) Predicate Indications for Use: The Synthes 3.5 mm Locking Compression Plate (LCP) System is indicated for fixation of fractures… | 2008 |
What descends from it? (7)
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 15 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K191848 (Medartis AG, 2019) has gone furthest, with 2 descendants of its own.
- 42 other devices also cite its predicate K082807.
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 Acumed Wrist Spanning Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131764 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131764: Acumed Wrist Spanning Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131764
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