510(k) · Cleared
ClearedSynthes Rib Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Sep 8, 2008 after a 90-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.
- Decided
- Sep 8, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 2 citing it directly.
- This deviceK081623 Synthes Rib Fixation SystemSynthes (Usa) · 2008
- Descendant · cites it directly · 26 of its ownK133616 Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014
- Descendant · 2 generations on · 23 of its ownK142823 Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015
- Descendant · 3 generations on · 13 of its ownK151173 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015
- Descendant · 3 generations on · 11 of its ownK152253 Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016
- Descendant · 3 generations on · 9 of its ownK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K133616Matrixrib Fixation SystemSynthes (USA) Products, LLC · 2014 · cites it directly26descendants
- K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation · 2015 · 2 generations on23descendants
- K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2015 · 3 generations on13descendants
- K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation · 2016 · 3 generations on11descendants
- K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081623 | Synthes Rib Fixation System | Synthes (Usa) | 2008 | — |
| +1 | K133616 | Matrixrib Fixation System | Synthes (USA) Products, LLC | 2014 | — |
| +2 | K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| +3 | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2015 | — |
| +3 | K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016 | — |
| +3 | K153482 | KLS Martin Thoracic Plating System | KLS-Martin L.P. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | — | Acumed Rib Congruent Bone Plate System Named without a submission number | |
| * | — | Synthes Sternal Fixation System Named without a submission number | |
| * | — | MatrixMANDIBLE Plate and Screw System Named without a submission number | |
| * | — | OrthoPro Steinman Pins And Kirschner Wires Named without a submission number |
What descends from it? (31)
See all 312 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133616 (Synthes (USA) Products, LLC, 2014) has gone furthest, with 26 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. 2008, 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 Synthes MatrixRIB Fixation System is indicated for the fixation and stabilization of rib fractures, fusions and osteotomies of normal and osteoporotic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081623 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081623: Synthes Rib Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081623
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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