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 Jul 18, 2007 as substantially equivalent to K012655 (Acu Med, Inc., 2001) after a 26-day review. Its family tree reaches back 3 generations to 2000. 34 later devices descend from it.
- Decided
- Jul 18, 2007
- Review
- 26 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). 34 later devices descend from it, 8 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 deviceK071715 Acumed Congruent Bone Plate SystemAcumed, LLC · 2007
- Descendant · cites it directly · 15 of its ownK080184 Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · Recalled
- Descendant · cites it directly · 11 of its ownK113733 Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
- Descendant · 2 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 2 generations on · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
- Descendant · 3 generations on · 4 of its ownK182718 Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · cites it directly15descendants
- K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012 · cites it directly11descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 2 generations on10descendants
- K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014 · 2 generations on8descendants
- K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda. · 2019 · 3 generations on4descendants
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) | K071715 | Acumed Congruent Bone Plate System | Acumed, LLC | 2007 | — |
| +1 | K080184 | Distal Humeral Plates with Angular Stability | I.T.S. Implantat-Technologie-Systeme GmbH | 2008 | 1 |
| +1 | K113733 | Small and Large Fragments Osteosynthesis System Neofix | Neoortho Produtos Ortopedicos S/A | 2012 | — |
| +2 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +2 | K142419 | Mini and Micro Fragments Reconstruction System-NEOFIX | Neoortho Productos Orthopedicos S/A | 2014 | — |
| +3 | K182718 | Mini and Micro Fragments Reconstruction System – GMReis | Gm Dos Reis Industria E Comerico Ltda. | 2019 | — |
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 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2017 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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: HRS Legally Marketed Equivalent Device(s): Acumed LLC Congruent Bone Plate System K01 2655 Device Description: The Acumed Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteo… | 2001 |
What descends from it? (34)
See all 348 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 |
| K113733 | Small and Large Fragments Osteosynthesis System Neofix | 2012 | 11 |
| K140357 | Oic Variable Angle Small Fragment Locking Plate System | 2014 | 2 |
| K130008 | Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous… | 2013 | 1 |
| K103513 | Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left… | 2011 | 1 |
| K242988 | Genostis Osteosynthesis System | 2025 | 0 |
| K161861 | APTUS® Coronoid 2.0 | 2017 | 0 |
| K142306 | Flower Upper Extremity Plating Set | 2014 | 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 7 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. 2007, 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 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/K071715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071715: Acumed Congruent Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071715
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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