510(k) · Cleared
Recalled · 2011Acumed Rib Congrient 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 21, 2005 as substantially equivalent to K012655 (Acu Med, Inc., 2001) and 2 other predicates after a 51-day review. Its family tree reaches back 3 generations to 2000. 9 later devices descend from it. It has been recalled once.
- Decided
- Jul 21, 2005
- Review
- 51 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000684 (2000). 11 ancestors in all, the oldest K890939 (1989). 9 later devices descend from it, 1 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 deviceK051410 Acumed Rib Congrient Bone Plate SystemAcumed, LLC · 2005
- Descendant · cites it directly · 8 of its ownK113318 Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK141241 Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014
- Descendant · 3 generations on · 4 of its ownK183317 AdvantageRib SystemSig Medical Corporation · 2019
- Descendant · 4 generations on · 3 of its ownK203474 Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021
- Descendant · 2 generations on · 1 of its ownK221412 ARIX Rib SystemJeil Medical Corporation · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · cites it directly8descendants
- K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014 · 2 generations on5descendants
- K183317AdvantageRib SystemSig Medical Corporation · 2019 · 3 generations on4descendants
- K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021 · 4 generations on3descendants
- K221412ARIX Rib SystemJeil Medical Corporation · 2022 · 2 generations on1descendant
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) | K051410 | Acumed Rib Congrient Bone Plate System | Acumed, LLC | 2005 | — |
| +1 | K113318 | Acute Innovations Modular Ribloc System | Acute Innovations, LLC | 2012 | 1 |
| +2 | K141241 | Matrixrib Endo Thoracoscopic Rib Plating System | Synthes (USA) Products, LLC | 2014 | — |
| +3 | K183317 | AdvantageRib System | Sig Medical Corporation | 2019 | — |
| +4 | K203474 | Biomet Microfixation RibFix Advantage System | Biomet Micofixation | 2021 | — |
| +2 | K221412 | ARIX Rib System | Jeil Medical Corporation | 2022 | — |
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 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 1…Class 11, 21 CFR 888.3030 Device Product Code: HRS Legally Marketed Equivalent Device(s): Acumed LLC Congruent Bone Plate System K012655 KLS-Martin Sternal Plating System K032413… | 2001 |
| * | K032413 | KLS-Martin Sternal Plating SystemSummary page 1…Legally Marketed Equivalent Device(s): Acumed LLC Congruent Bone Plate System K012655 KLS-Martin Sternal Plating System K032413 MacroPore OS Trauma K024169 Device Description: The Acumed Rib Congruent Bone Plat… | 2003 |
| * | K024169 | Macropore OS ReconstructionSummary page 1…te System K012655 KLS-Martin Sternal Plating System K032413 MacroPore OS Trauma K024169 Device Description: The Acumed Rib Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and… | 2003 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113318 | Acute Innovations Modular Ribloc System | 2012 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2011 | Not classified | Z-0336-2012 | Process control | RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K113318 (Acute Innovations, LLC, 2012) has gone furthest, with 8 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 Rib Congruent Bone Plate System provides fixation during fractures,
fusions, and osteotomies for the rib.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051410: Acumed Rib Congrient 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/K051410
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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