510(k) · Cleared
Recalled · Class II · 2026The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
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 Jul 14, 2025 as substantially equivalent to K233311 (Acumed, LLC, 2024) and 1 other predicate after a 94-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 14, 2025
- Review
- 94 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K000684 (2000). 23 ancestors in all, the oldest K890939 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 4 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 3 generations backK102998 Congruent Bone Plate SystemAcumed, LLC · 2011
- 2 generations backK120903 Congruent Bone Plate System: Acu-Loc 2 PlateAcumed, LLC · 2012
- 1 generation backK233311 Acumed Wrist Plating SystemAcumed, LLC · 2024
- This deviceK251132 The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation…Acumed, LLC · 2025
- Descendant · cites it directly · 0 of its ownK252356 The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −4 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −3 | K102998 | Congruent Bone Plate System | Acumed, LLC | 2011 | — |
| −2 | K120903 | Congruent Bone Plate System: Acu-Loc 2 Plate | Acumed, LLC | 2012 | — |
| −1 | K233311 | Acumed Wrist Plating System | Acumed, LLC | 2024 | — |
| 0 (this device) | K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System -… | Acumed, LLC | 2025 | — |
| +1 | 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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K233311 | Acumed Wrist Plating SystemSummary page 5…3040 Product Code(s) HRS, HWC | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233311 The Acumed Wrist Plating System HRS K131764 Acumed Wrist Spanning Plate HRS Device Description Summary 21 CFR 807.92(a)(4) The A… | 2024 |
| * | K131764 | Acumed Wrist Spanning PlateSummary page 5…keted Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K233311 The Acumed Wrist Plating System HRS K131764 Acumed Wrist Spanning Plate HRS Device Description Summary 21 CFR 807.92(a)(4) The Acumed Wrist Fixation System is a new system… | 2013 |
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 |
|---|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2026 | Class II | Z-2532-2026 | Device Design | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 23 ancestors have a recall of any class.
- Of its descendants, K252356 (Acumed, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K233311.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Indications for Use for The Acumed Wrist Fixation System / Plates, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.
The Indications for Use for The Acumed Wrist Fixation System/ Screws, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.
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/K251132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251132: The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251132
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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