510(k) · Cleared
ClearedAcumed Congruent Bone Plate 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 Dec 7, 2006 as substantially equivalent to K012655 (Acu Med, Inc., 2001) after a 22-day review. Its family tree reaches back 3 generations to 2000. 21 later devices descend from it.
- Decided
- Dec 7, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000684 (2000). 8 ancestors in all, the oldest K890939 (1989). 21 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 2 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 1 generation backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- This deviceK063460 Acumed Congruent Bone Plate SystemAcumed, LLC · 2006
- Descendant · cites it directly · 15 of its ownK080184 Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · Recalled
- Descendant · 2 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 3 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · cites it directly15descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 2 generations on10descendants
- K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 3 generations on3descendants
- K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · 2 generations on3descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −2 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −1 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| 0 (this device) | K063460 | Acumed Congruent Bone Plate System | Acumed, LLC | 2006 | — |
| +1 | K080184 | Distal Humeral Plates with Angular Stability | I.T.S. Implantat-Technologie-Systeme GmbH | 2008 | 1 |
| +2 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +3 | K161327 | Syntec Humeral Nail System | Syntec Scientific Corporation | 2017 | — |
| +2 | K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017 | — |
| +3 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K012655 | Congruent Bone Plate SystemSummary page 1…Class II, 21 CFR 888.3030 Device Product Code: fiRS Legally Marketed Equivalent Device(s): Acumed LLC Congruent Bone Plate System K012655 Device Description: The Acumed Scapula Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, a… | 2001 |
What descends from it? (21)
See all 215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080184 | Distal Humeral Plates with Angular Stability | 2008 | 15 |
| K103513 | Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left… | 2011 | 1 |
| K181843 | MLP Special Locking Bone Plate System | 2019 | 0 |
| K142306 | Flower Upper Extremity Plating Set | 2014 | 0 |
| K110322 | Olecra Intramedullary Fixation System | 2011 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K080184 (I.T.S. Implantat-Technologie-Systeme GmbH, 2008) has gone furthest, with 15 descendants 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.
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 Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia. and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063460 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063460: Acumed Congruent Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063460
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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