510(k) · Cleared
ClearedPectus Versa System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gm Dos Reis Industria E Comercio · HRS Plate, Fixation, Bone
Cleared on Dec 19, 2025 as substantially equivalent to K191057 (Tdm Co., Ltd., 2020) and 1 other predicate after a 260-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Dec 19, 2025
- Review
- 260 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K972420 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
- 3 generations backK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
- 2 generations backK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
- 1 generation backK191057 Park's Pectus SystemTdm Co., Ltd. · 2020
- This deviceK251050 Pectus Versa SystemGm Dos Reis Industria E Comercio · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972420 | Lorenz Pectus Support Bar | Walter Lorenz Surgical, Inc. | 1997 | — |
| −3 | K981789 | Lorenz Pectus Support Bar Stabilizer | Walter Lorenz Surgical, Inc. | 1998 | — |
| −2 | K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer… | Walter Lorenz Surgical, Inc. | 2006 | — |
| −1 | K191057 | Park's Pectus System | Tdm Co., Ltd. | 2020 | — |
| 0 (this device) | K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K191057 | Park's Pectus SystemSummary page 5…CFR 888.3030 III. Predicate Devices: Legally marketed device to which we are claiming “Substantial Equivalence” are the following: Park's Pectus System - TDM Co. Ltd (K191057) (Predicate Device) (Primary) Pectus Support Bar System - Biomet (K213712) (Predicate Device) Versalock Rib and Sternum Plates Sy… | 2020 |
| * | K213712 | Pectus Support Bar SystemSummary page 5…e are claiming “Substantial Equivalence” are the following: Park's Pectus System - TDM Co. Ltd (K191057) (Predicate Device) (Primary) Pectus Support Bar System - Biomet (K213712) (Predicate Device) Versalock Rib and Sternum Plates System - GMReis (K232829) (Reference Device) KLS Martin Pure Pectus System -… | 2022 |
| † | K232829 | Versalock Rib and Sternum Plates System | 2024 |
| † | K221938 | KLS Martin Pure Pectus System | 2023 |
| † | K182718 | Mini and Micro Fragments Reconstruction System – GMReis | 2019 |
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 28 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K191057.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Pectus Versa System is indicated for the treatment of Pectus Excavatum and other anterior chest wall deformities in adult and pediatric patients (children and adolescents).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251050 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251050: Pectus Versa System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251050
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