510(k) · Cleared
ClearedAdvantageRib System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sig Medical Corporation · HRS Plate, Fixation, Bone
Cleared on Feb 14, 2019 as substantially equivalent to K141241 (Synthes (USA) Products, LLC, 2014) after a 76-day review. Its family tree reaches back 6 generations to 2000. 4 later devices descend from it.
- Decided
- Feb 14, 2019
- Review
- 76 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000684 (2000). 27 ancestors in all, the oldest K890939 (1989). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 4 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 3 generations backK051410 Acumed Rib Congrient Bone Plate SystemAcumed, LLC · 2005 · Recalled
- 2 generations backK113318 Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · Recalled
- 1 generation backK141241 Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014
- This deviceK183317 AdvantageRib SystemSig Medical Corporation · 2019
- Descendant · cites it directly · 3 of its ownK203474 Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021
- Descendant · 2 generations on · 0 of its ownK261892 ProRib Fixation SystemCosta Surgical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260411 PC Fix SystemChest Wall Innovations, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241282 RibFix Titan™ Fixation SystemRiverpoint Medical · 2024
Most influential descendants
Showing 4 of 4 · See all- K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021 · cites it directly3descendants
- K261892ProRib Fixation SystemCosta Surgical, Inc. · 2026 · 2 generations on0descendants
- K260411PC Fix SystemChest Wall Innovations, Inc. · 2026 · 2 generations on0descendants
- K241282RibFix Titan™ Fixation SystemRiverpoint Medical · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −4 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −3 | K051410 | Acumed Rib Congrient Bone Plate System | Acumed, LLC | 2005 | 1 |
| −2 | K113318 | Acute Innovations Modular Ribloc System | Acute Innovations, LLC | 2012 | 1 |
| −1 | K141241 | Matrixrib Endo Thoracoscopic Rib Plating System | Synthes (USA) Products, LLC | 2014 | — |
| 0 (this device) | K183317 | AdvantageRib System | Sig Medical Corporation | 2019 | — |
| +1 | K203474 | Biomet Microfixation RibFix Advantage System | Biomet Micofixation | 2021 | — |
| +2 | K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026 | — |
| +2 | K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026 | — |
| +2 | K241282 | RibFix Titan™ Fixation System | Riverpoint Medical | 2024 | — |
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 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K141241 | Matrixrib Endo Thoracoscopic Rib Plating SystemSummary page 4…Class: Class II Product Codes: HRS, HWC Reviewing Panel: Orthopedic Primary Predicate Device: MatrixRIB Endo Thorascopic Rib Plating System (K141241) Device Description: The AdvantageRib System consists of bridges (with locking posts) and locking caps for the thoracoscopic fi… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203474 | Biomet Microfixation RibFix Advantage System | 2021 | 3 |
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 19 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- 7 of the 27 ancestors have a recall of any class.
- Of its descendants, K203474 (Biomet Micofixation, 2021) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183317: AdvantageRib System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183317
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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