510(k) · Cleared
ClearedCongruent 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 Jan 4, 2011 as substantially equivalent to K012655 (Acu Med, Inc., 2001) after an 88-day review. Its family tree reaches back 3 generations to 2000. 91 later devices descend from it.
- Decided
- Jan 4, 2011
- Review
- 88 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). 91 later devices descend from it, 10 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 deviceK102998 Congruent Bone Plate SystemAcumed, LLC · 2011
- Descendant · cites it directly · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- Descendant · 2 generations on · 38 of its ownK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 23 of its ownK141478 Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 21 of its ownK151732 Arthrex Fracture PlatesArthrex, Inc. · 2015
- Descendant · 2 generations on · 15 of its ownK170518 In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · Recalled
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · cites it directly71descendants
- K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · 2 generations on38descendants
- K141478Arthrex Fracture Plates and ScrewsArthrex, Inc. · 2014 · 2 generations on23descendants
- K151732Arthrex Fracture PlatesArthrex, Inc. · 2015 · 2 generations on21descendants
- K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC · 2017 · 2 generations on15descendants
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) | K102998 | Congruent Bone Plate System | Acumed, LLC | 2011 | — |
| +1 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| +2 | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | 1 |
| +2 | K141478 | Arthrex Fracture Plates and Screws | Arthrex, Inc. | 2014 | 1 |
| +2 | K151732 | Arthrex Fracture Plates | Arthrex, Inc. | 2015 | — |
| +2 | K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | 2017 | 1 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 0 |
| 2026 | 20 | 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 2…Page 2 of 2 Predicate Device: The modified Congruent Bone Plate System is substantially equivalent to the predicate Congruent Bone Plate System pre'viously cleared in K012655 with respect to indications, design, function, and materials. Preclinical Testing: The new components were subjected to static a… | 2001 |
What descends from it? (91)
See all 9110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123241 | Arthrex Fracture Plates | 2013 | 71 |
| K120903 | Congruent Bone Plate System: Acu-Loc 2 Plate | 2012 | 6 |
| K130774 | Universal Distal Radius System | 2013 | 5 |
| K233311 | Acumed Wrist Plating System | 2024 | 3 |
| K200538 | Skeletal Dynamics Forearm Plating System | 2020 | 1 |
| K242988 | Genostis Osteosynthesis System | 2025 | 0 |
| K243469 | Signex | 2025 | 0 |
| K171372 | Alians Elbow Locking Plating System | 2018 | 0 |
| K170310 | Alians Clavicle range | 2017 | 0 |
| K131834 | Wolf Long Bone Plate System | 2013 | 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 11 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, K123241 (Arthrex, Inc., 2013) has gone furthest, with 71 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. 2011, 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 clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102998 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102998: Congruent Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102998
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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