510(k) · Cleared
ClearedBiomet Microfixation RibFix Advantage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Micofixation · HRS Plate, Fixation, Bone
Cleared on Jan 28, 2021 as substantially equivalent to K183317 (Sig Medical Corporation, 2019) after a 64-day review. Its family tree reaches back 7 generations to 2000. 3 later devices descend from it.
- Decided
- Jan 28, 2021
- Review
- 64 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000684 (2000). 28 ancestors in all, the oldest K890939 (1989). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 6 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 5 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 4 generations backK051410 Acumed Rib Congrient Bone Plate SystemAcumed, LLC · 2005 · Recalled
- 3 generations backK113318 Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · Recalled
- 2 generations backK141241 Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014
- 1 generation backK183317 AdvantageRib SystemSig Medical Corporation · 2019
- This deviceK203474 Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021
- Descendant · cites it directly · 0 of its ownK261892 ProRib Fixation SystemCosta Surgical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK260411 PC Fix SystemChest Wall Innovations, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK241282 RibFix Titan™ Fixation SystemRiverpoint Medical · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −6 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −5 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −4 | K051410 | Acumed Rib Congrient Bone Plate System | Acumed, LLC | 2005 | 1 |
| −3 | K113318 | Acute Innovations Modular Ribloc System | Acute Innovations, LLC | 2012 | 1 |
| −2 | K141241 | Matrixrib Endo Thoracoscopic Rib Plating System | Synthes (USA) Products, LLC | 2014 | — |
| −1 | K183317 | AdvantageRib System | Sig Medical Corporation | 2019 | — |
| 0 (this device) | K203474 | Biomet Microfixation RibFix Advantage System | Biomet Micofixation | 2021 | — |
| +1 | K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026 | — |
| +1 | K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K183317 | AdvantageRib SystemSummary page 5…als, sterilization method, and indications for use are identical between the subject device and the predicate device. Substantial Equivalence: Primary Predicate Device: K183317, AdvantageRib System The similarities of the subject devices to the predicate devices are as follows: The indications for u… | 2019 |
| † | K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | 2016 |
| † | K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | 2016 |
What descends from it? (3)
3 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?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 7 of the 28 ancestors have a recall of any class.
- Of its descendants, K261892 (Costa Surgical, Inc., 2026) has gone furthest, with 0 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. 2021, 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 RibFix Advantage System is indicated for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203474 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203474: Biomet Microfixation RibFix Advantage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203474
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