510(k) · Cleared
ClearedPark's Pectus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tdm Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Mar 19, 2020 as substantially equivalent to K061384 (Walter Lorenz Surgical, Inc., 2006) after a 332-day review. Its family tree reaches back 3 generations to 1997. 5 later devices descend from it.
- Decided
- Mar 19, 2020
- Review
- 332 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972420 (1997). 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK972420 Lorenz Pectus Support BarWalter Lorenz Surgical, Inc. · 1997
- 2 generations backK981789 Lorenz Pectus Support Bar StabilizerWalter Lorenz Surgical, Inc. · 1998
- 1 generation backK061384 Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar…Walter Lorenz Surgical, Inc. · 2006
- This deviceK191057 Park's Pectus SystemTdm Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK243357 CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK250892 CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK260448 CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251050 Pectus Versa SystemGm Dos Reis Industria E Comercio · 2025
- Descendant · cites it directly · 0 of its ownK242751 ARIX Pectus Bar SystemJeil Medical Corporation · 2025
Most influential descendants
Showing 5 of 5 · See all- K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025 · cites it directly2descendants
- K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025 · cites it directly1descendant
- K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2026 · 2 generations on0descendants
- K251050Pectus Versa SystemGm Dos Reis Industria E Comercio · 2025 · cites it directly0descendants
- K242751ARIX Pectus Bar SystemJeil Medical Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972420 | Lorenz Pectus Support Bar | Walter Lorenz Surgical, Inc. | 1997 | — |
| −2 | K981789 | Lorenz Pectus Support Bar Stabilizer | Walter Lorenz Surgical, Inc. | 1998 | — |
| −1 | K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer… | Walter Lorenz Surgical, Inc. | 2006 | — |
| 0 (this device) | K191057 | Park's Pectus System | Tdm Co., Ltd. | 2020 | — |
| +1 | K243357 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025 | — |
| +1 | K250892 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025 | — |
| +2 | K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026 | — |
| +1 | K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio | 2025 | — |
| +1 | K242751 | ARIX Pectus Bar System | Jeil Medical Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K061384 | Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, TitaniumSummary page 4…II -. Product Code : HRS 4. Primary predicate Device -. Trade / Device Name : Lorenz Pectus Support Bar System -. 510(k) Number : K061384 -. Regulation Number : 21 CFR 888.3030 -. Regulation Name : Single/multiple component metallic bone fixation applianc… | 2006 |
| † | K171808 | TDM Plate and Screw System | 2018 |
| † | K190391 | TDM Plate and Screw Systems | 2019 |
What descends from it? (5)
4 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 23 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K243357 (L&K BIOMED Co., Ltd., 2025) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K061384.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Park’s Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191057: Park's Pectus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191057
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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