510(k) · Cleared
ClearedPioneer Sternal Cable Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · HRS Plate, Fixation, Bone
Cleared on Oct 12, 2012 as substantially equivalent to K946173 (ETHICON, Inc., 1995) and 5 other predicates after a 73-day review. Its family tree reaches back 9 generations to 1976. 46 later devices descend from it.
- Decided
- Oct 12, 2012
- Review
- 73 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K761228 (1976). 26 ancestors in all. 46 later devices descend from it, 1 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 backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 1 generation backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- This deviceK122293 Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · cites it directly · 45 of its ownK133785 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 44 of its ownK150581 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015
- Descendant · 3 generations on · 43 of its ownK161876 Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016
- Descendant · 4 generations on · 40 of its ownK193468 Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
- 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
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 backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- 1 generation backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
- This deviceK122293 Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2014 · cites it directly45descendants
- K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · 2 generations on44descendants
- K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016 · 3 generations on43descendants
- K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020 · 4 generations on40descendants
- K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 2 generations on39descendants
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 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| −1 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
| 0 (this device) | K122293 | Pioneer Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +1 | K133785 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 2014 | 1 |
| +2 | K150581 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015 | — |
| +3 | K161876 | Tritium® Sternal Cable Plate System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2016 | — |
| +4 | K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020 | — |
| +2 | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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? (6)
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 |
|---|---|---|---|
| * | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…Summary page 1…on-Spinal, Metallic (HRS) §888.3040 Screw, Fixation, Bone, Non-Spinal, Metallic (HWC) Predicate Devices: Ethicon Stainless Steel Suture Wire (K946 173) Pioneer Songer Cable System (K93548 1) Lorenz Sternal Closure System with Modular… | 1995 |
| * | K935481 | Sponger Cable System, ModificationSummary page 1…ew, Fixation, Bone, Non-Spinal, Metallic (HWC) Predicate Devices: Ethicon Stainless Steel Suture Wire (K946 173) Pioneer Songer Cable System (K93548 1) Lorenz Sternal Closure System with Modular Screw (Biomet SternaLock) (KOI 11076)… | 1994 |
| * | K011076 | Lorenz Sternal Closure System with Modular Screw | 2001 |
| * | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | 2011 |
| * | K031508 | Synthes (Usa) Sternal Reconstruction SystemSummary page 1…Biomet SternaLock Biu Microfixation Sternal Closure System (KI 10574) Synthes Modular Sternal Cable / Sternal Reconstruction System (K03 1508/ K0338 16) Description: The Pioneer Sternal Cable Plate System contains various configurations… | 2003 |
| * | K033816 | Synthes (Usa) Modification to Sternal Reconstruction SystemSummary page 1…iu Microfixation Sternal Closure System (KI 10574) Synthes Modular Sternal Cable / Sternal Reconstruction System (K03 1508/ K0338 16) Description: The Pioneer Sternal Cable Plate System contains various configurations of plates,… | 2004 |
What descends from it? (46)
See all 461 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133785 | Tritium Sternal Cable Plate System | 2014 | 45 |
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.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K133785 (Pioneer Surgical Technology, Inc., 2014) has gone furthest, with 45 descendants of its own.
- 18 other devices also cite its predicate K946173.
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 Pioneer Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122293 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122293: Pioneer Sternal Cable Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122293
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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