510(k) · Cleared
ClearedPC Fix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chest Wall Innovations, Inc. · HRS Plate, Fixation, Bone
Cleared on Apr 24, 2026 as substantially equivalent to K203474 (Biomet Micofixation, 2021) after a 74-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Apr 24, 2026
- Review
- 74 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K000684 (2000). 29 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.
- Root · 8 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 7 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 6 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 5 generations backK051410 Acumed Rib Congrient Bone Plate SystemAcumed, LLC · 2005 · Recalled
- 4 generations backK113318 Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · Recalled
- 3 generations backK141241 Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014
- 2 generations backK183317 AdvantageRib SystemSig Medical Corporation · 2019
- 1 generation backK203474 Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021
- This deviceK260411 PC Fix SystemChest Wall Innovations, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −7 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −6 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −5 | K051410 | Acumed Rib Congrient Bone Plate System | Acumed, LLC | 2005 | 1 |
| −4 | K113318 | Acute Innovations Modular Ribloc System | Acute Innovations, LLC | 2012 | 1 |
| −3 | K141241 | Matrixrib Endo Thoracoscopic Rib Plating System | Synthes (USA) Products, LLC | 2014 | — |
| −2 | K183317 | AdvantageRib System | Sig Medical Corporation | 2019 | — |
| −1 | K203474 | Biomet Microfixation RibFix Advantage System | Biomet Micofixation | 2021 | — |
| 0 (this device) | K260411 | PC Fix System | Chest Wall Innovations, 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 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 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 |
|---|---|---|---|
| * | K203474 | Biomet Microfixation RibFix Advantage SystemSummary page 5…Class II Product Code: HRS, HTN Review Panel: Orthopedic Primary Predicate: Zimmer Biomet RibFix Advantage System (K203474) Reference Devices: Riverpoint Medical RibFix Titan Fixation System (K241282) Able… | 2021 |
| † | K241282 | RibFix Titan™ Fixation System | 2024 |
| † | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 8 companies; a new generation was cleared every 3.7 years on median.
- 7 of the 29 ancestors have a recall of any class.
- 2 other devices also cite its predicate K203474.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 PC Fix System is indicated 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/K260411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260411: PC Fix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260411
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026