510(k) · Cleared
Recalled · Class II · 2013Acute Innovations Modular Ribloc System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acute Innovations, LLC · HRS Plate, Fixation, Bone
Cleared on Jan 12, 2012 as substantially equivalent to K073556 (Medxpert GmbH, 2008) and 2 other predicates after a 63-day review. Its family tree reaches back 4 generations to 2000. 8 later devices descend from it. It has been recalled once.
- Decided
- Jan 12, 2012
- Review
- 63 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000684 (2000). 22 ancestors in all, the oldest K890939 (1989). 8 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 2 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 1 generation backK051410 Acumed Rib Congrient Bone Plate SystemAcumed, LLC · 2005 · Recalled
- This deviceK113318 Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012
- Descendant · cites it directly · 5 of its ownK141241 Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014
- Descendant · 2 generations on · 4 of its ownK183317 AdvantageRib SystemSig Medical Corporation · 2019
- Descendant · 3 generations on · 3 of its ownK203474 Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021
- Descendant · cites it directly · 1 of its ownK221412 ARIX Rib SystemJeil Medical Corporation · 2022
- Descendant · 4 generations on · 0 of its ownK261892 ProRib Fixation SystemCosta Surgical, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014 · cites it directly5descendants
- K183317AdvantageRib SystemSig Medical Corporation · 2019 · 2 generations on4descendants
- K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021 · 3 generations on3descendants
- K221412ARIX Rib SystemJeil Medical Corporation · 2022 · cites it directly1descendant
- K261892ProRib Fixation SystemCosta Surgical, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −3 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −2 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −1 | K051410 | Acumed Rib Congrient Bone Plate System | Acumed, LLC | 2005 | 1 |
| 0 (this device) | K113318 | Acute Innovations Modular Ribloc System | Acute Innovations, LLC | 2012 | — |
| +1 | K141241 | Matrixrib Endo Thoracoscopic Rib Plating System | Synthes (USA) Products, LLC | 2014 | — |
| +2 | K183317 | AdvantageRib System | Sig Medical Corporation | 2019 | — |
| +3 | K203474 | Biomet Microfixation RibFix Advantage System | Biomet Micofixation | 2021 | — |
| +1 | K221412 | ARIX Rib System | Jeil Medical Corporation | 2022 | — |
| +4 | K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K073556 | Medxpert P.E.S. (Pectus Exacvatum System), Medxpert StratosSummary page 1…ation presented in the 5 10(k) supports the substantial equivalence of the ACUTE Innovations® Modular RibLoc System to the following predicate devices: MedXpert STRATOS (K073556); ACUTE Innovations® RibLoc System (K051410); and ACUTE Innovations Sternal Fixation System (KI10I1170). Substant… | 2008 |
| * | K051410 | Acumed Rib Congrient Bone Plate SystemSummary page 1…substantial equivalence of the ACUTE Innovations® Modular RibLoc System to the following predicate devices: MedXpert STRATOS (K073556); ACUTE Innovations® RibLoc System (K051410); and ACUTE Innovations Sternal Fixation System (KI10I1170). Substantial Equivalence: The components of the Acute… | 2005 |
| * | K101170 | Acute Innovations Sternal Fixation System | 2010 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2013 | Class II | Z-0852-2014 | Under Investigation by firm | The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K141241 (Synthes (USA) Products, LLC, 2014) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K073556.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 ACUTE Innovations® Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113318: Acute Innovations Modular Ribloc System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113318
Report an extraction error
Are you the manufacturer?
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