510(k) · Cleared
ClearedKLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile
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 Mar 26, 2007 as substantially equivalent to K062857 (KLS Martin L.P., 2006) and 3 other predicates after a 67-day review. Its family tree reaches back 8 generations to 1976. 61 later devices descend from it.
- Decided
- Mar 26, 2007
- Review
- 67 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K761228 (1976). 81 ancestors in all. 61 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 7 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 6 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 5 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 4 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 3 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- 2 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- 1 generation backK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
- This deviceK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- Descendant · cites it directly · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
- Descendant · 2 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
- Descendant · 3 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 4 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 4 generations on · 13 of its ownK222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous…Alphatec Spine, Inc. · 2022
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · cites it directly45descendants
- K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 2 generations on39descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 3 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 4 generations on28descendants
- K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc. · 2022 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −7 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −6 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −4 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −3 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| −2 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| −1 | K051165 | KLS Martin Sternal Talon | KLS-Martin L.P. | 2006 | — |
| 0 (this device) | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| +1 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
| +2 | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | 2021 | — |
| +3 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +4 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +4 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti… | Alphatec Spine, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 12 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | K062857 | KLS Martin Quick DiscSummary page 2…ces and accessories (CFR 888.3030 5i Regulatory Class: I Predicate Devices: KLS Martin Quick Disc (K062857) KLS Martin Sternal Talon (K051 165) KILS Martin Sternal Plating System (K032413)… | 2006 |
| * | K051165 | KLS Martin Sternal TalonSummary page 2…5i Regulatory Class: I Predicate Devices: KLS Martin Quick Disc (K062857) KLS Martin Sternal Talon (K051 165) KILS Martin Sternal Plating System (K032413) KLS Martin Rigid Fixation - Sterile (K0… | 2006 |
| * | K032413 | KLS-Martin Sternal Plating SystemSummary page 2…Predicate Devices: KLS Martin Quick Disc (K062857) KLS Martin Sternal Talon (K051 165) KILS Martin Sternal Plating System (K032413) KLS Martin Rigid Fixation - Sterile (K060177) Intended Use: To offer KLS Martin Quick Disc, KILS Ma… | 2003 |
| * | K060177 | KLS Martin Rigid Fixation - SterileSummary page 2…KLS Martin Sternal Talon (K051 165) KILS Martin Sternal Plating System (K032413) KLS Martin Rigid Fixation - Sterile (K060177) Intended Use: To offer KLS Martin Quick Disc, KILS Martin Sternal Talon and KLS Martin Sternal Plati… | 2006 |
What descends from it? (61)
See all 616 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 31 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 81 ancestors have a recall of any class.
- Of its descendants, K151983 (KLS Martin L.P., 2016) has gone furthest, with 45 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. 2007, 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?
To offer KLS Martin Quick Disc, KLS Martin Sternal Talon and KLS Martin Sternal Plating in sterile packaging with the following indications for use:
K062857 KLS Martin Quick Disc is intended for use in the reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures.
K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are 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/K070169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070169
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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