510(k) · Cleared
ClearedPioneer Sternal Assist Implant 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 Jul 26, 2012 as substantially equivalent to K101170 (Acute Innovations, LLC, 2010) and 4 other predicates after a 205-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jul 26, 2012
- Review
- 205 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K011076 (2001). 11 ancestors in all, the oldest K931271 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK011076 Lorenz Sternal Closure System with Modular ScrewWalter Lorenz Surgical, Inc. · 2001
- 2 generations backK032413 KLS-Martin Sternal Plating SystemKLS-Martin L.P. · 2003
- 1 generation backK101170 Acute Innovations Sternal Fixation SystemAcute Innovations, LLC · 2010
- This deviceK120016 Pioneer Sternal Assist Implant SystemPioneer Surgical Technology, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011076 | Lorenz Sternal Closure System with Modular Screw | Walter Lorenz Surgical, Inc. | 2001 | — |
| −2 | K032413 | KLS-Martin Sternal Plating System | KLS-Martin L.P. | 2003 | — |
| −1 | K101170 | Acute Innovations Sternal Fixation System | Acute Innovations, LLC | 2010 | — |
| 0 (this device) | K120016 | Pioneer Sternal Assist Implant System | Pioneer Surgical Technology, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (5)
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 |
|---|---|---|---|
| * | K101170 | Acute Innovations Sternal Fixation System | 2010 |
| * | K110789 | Synthes Sternal Zipfix System | 2011 |
| * | K935481 | Sponger Cable System, ModificationSummary page 1…dicate Devices: KIOl 170 ACUTE Innovations Acutie Sternal Fixation System (SE 9/17/10) Ki 10789 Synthes ZipFix (SE 7/28/11) K935481 Pioneer Songer Cable System (SE 1/26/94) K931271/K946173 -Ethicon Stainless Steel Suture Wire (SE 1/9/95)… | 1994 |
| * | K931271 | Ethi-Pack* Surgical Stainless Steel SutureSummary page 1…stem (SE 9/17/10) Ki 10789 Synthes ZipFix (SE 7/28/11) K935481 Pioneer Songer Cable System (SE 1/26/94) K931271/K946173 -Ethicon Stainless Steel Suture Wire (SE 1/9/95) Intended Use: The Pioneer Sternal Assist Implant System is inte… | 1994 |
| * | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…Summary page 1…9/17/10) Ki 10789 Synthes ZipFix (SE 7/28/11) K935481 Pioneer Songer Cable System (SE 1/26/94) K931271/K946173 -Ethicon Stainless Steel Suture Wire (SE 1/9/95) Intended Use: The Pioneer Sternal Assist Implant System is intended for… | 1995 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K101170.
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 Assist Implant 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/K120016 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120016: Pioneer Sternal Assist Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120016
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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