510(k) · Cleared
ClearedKLS Martin Recon Talon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS Martin L.P. · HRS Plate, Fixation, Bone
Cleared on Nov 14, 2012 as substantially equivalent to K051165 (KLS-Martin L.P., 2006) and 2 other predicates after a 57-day review. Its family tree reaches back 9 generations to 1976. 10 later devices descend from it.
- Decided
- Nov 14, 2012
- Review
- 57 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K761228 (1976). 83 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 5 generations between
- 3 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 2 generations backK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
- 1 generation backK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- This deviceK122860 KLS Martin Recon TalonKLS Martin L.P. · 2012
- Descendant · cites it directly · 9 of its ownK153482 KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016
- Descendant · 2 generations on · 6 of its ownK221938 KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023
- Descendant · 2 generations on · 3 of its ownK222397 KLS Martin Level One Rib Fixation SystemKLS-Martin L.P. · 2023
- Descendant · 3 generations on · 2 of its ownK243357 CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025
- Descendant · 4 generations on · 1 of its ownK250892 CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 8 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 7 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 6 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 5 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 4 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 3 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 2 generations backK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
- 1 generation backK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- This deviceK122860 KLS Martin Recon TalonKLS Martin L.P. · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P. · 2016 · cites it directly9descendants
- K221938KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023 · 2 generations on6descendants
- K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P. · 2023 · 2 generations on3descendants
- K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025 · 3 generations on2descendants
- K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −8 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −7 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −6 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −5 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −4 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −3 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −2 | K051165 | KLS Martin Sternal Talon | KLS-Martin L.P. | 2006 | — |
| −1 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| 0 (this device) | K122860 | KLS Martin Recon Talon | KLS Martin L.P. | 2012 | — |
| +1 | K153482 | KLS Martin Thoracic Plating System | KLS-Martin L.P. | 2016 | — |
| +2 | K221938 | KLS Martin Pure Pectus System | KLS Martin L.P. | 2023 | — |
| +2 | K222397 | KLS Martin Level One Rib Fixation System | KLS-Martin L.P. | 2023 | — |
| +3 | K243357 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025 | — |
| +4 | K250892 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 9 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 5 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K051165 | KLS Martin Sternal TalonSummary page 1…Bone Fixation Plate Class 11, 21 CFR 888.3030, Product Code HRS Predicate Devices: KLS Martin Sternal Talon (K051165, K070169) Synthes Sternal Fixation System - Modification to Surgical… | 2006 |
| * | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileSummary page 1…Bone Fixation Plate Class 11, 21 CFR 888.3030, Product Code HRS Predicate Devices: KLS Martin Sternal Talon (K051165, K070169) Synthes Sternal Fixation System - Modification to Surgical Tec… | 2007 |
| * | K093772 | Synthes Sternal Fixation SystemSummary page 1…Sternal Talon (K051165, K070169) Synthes Sternal Fixation System - Modification to Surgical Technique (K093772) Device Description: The KLS Martin Recon Talon is a two-piece clamping device, which has on either end an attached… | 2010 |
What descends from it? (10)
2 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 36 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 83 ancestors have a recall of any class.
- Of its descendants, K153482 (KLS-Martin L.P., 2016) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K051165.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122860: KLS Martin Recon Talon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122860
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