510(k) · Cleared
ClearedAcumed Wrist Plating System
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 Apr 22, 2024 as substantially equivalent to K012655 (Acu Med, Inc., 2001) and 2 other predicates after a 206-day review. Its family tree reaches back 5 generations to 2000. 3 later devices descend from it.
- Decided
- Apr 22, 2024
- Review
- 206 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K000684 (2000). 10 ancestors in all, the oldest K890939 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 4 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 3 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 2 generations backK102998 Congruent Bone Plate SystemAcumed, LLC · 2011
- 1 generation backK120903 Congruent Bone Plate System: Acu-Loc 2 PlateAcumed, LLC · 2012
- This deviceK233311 Acumed Wrist Plating SystemAcumed, LLC · 2024
- Descendant · cites it directly · 1 of its ownK251132 The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation…Acumed, LLC · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK251732 Wrist Fracture SystemMet One Technologies, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK252356 The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC · 2025
Most influential descendants
Showing 3 of 3 · See all- K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC · 2025 · cites it directly1descendant
- K251732Wrist Fracture SystemMet One Technologies, LLC · 2026 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −5 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −4 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −3 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −2 | K102998 | Congruent Bone Plate System | Acumed, LLC | 2011 | — |
| −1 | K120903 | Congruent Bone Plate System: Acu-Loc 2 Plate | Acumed, LLC | 2012 | — |
| 0 (this device) | K233311 | Acumed Wrist Plating System | Acumed, LLC | 2024 | — |
| +1 | K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System -… | Acumed, LLC | 2025 | 1 |
| +1 | K251732 | Wrist Fracture System | Met One Technologies, LLC | 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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K012655 | Congruent Bone Plate SystemSummary page 4…21 CFR 888.3040 Product Code: HRS, HWC III. Legally Marketed Primary Predicate Devices Primary Predicate Device: Congruent Bone Plate System, K012655 Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessori… | 2001 |
| * | K120903 | Congruent Bone Plate System: Acu-Loc 2 PlateSummary page 4…metallic bone fixation appliances and Accessories Regulation Number: 21 CFR 888.3030 Product Code: HRS Predicate Device: Congruent Bone Plate System – Acu-Loc 2 Plate, K120903 / K102998 Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and… | 2012 |
| * | K102998 | Congruent Bone Plate SystemSummary page 4…one fixation appliances and Accessories Regulation Number: 21 CFR 888.3030 Product Code: HRS Predicate Device: Congruent Bone Plate System – Acu-Loc 2 Plate, K120903 / K102998 Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and Accessori… | 2011 |
| † | K132769 | Acumed Hand Plating System | 2014 |
| † | K130986 | Frag-Loc System | 2013 |
What descends from it? (3)
2 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 24 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K251132 (Acumed, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 27 other devices also cite its predicate K012655.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Acumed Wrist Plating System provides fixation for fractures, fusions, or osteotomies of the distal radius and ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233311: Acumed Wrist Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233311
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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