510(k) · Cleared
ClearedDAC Dynamic Active Compression Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc., Dba Rti Surgical · HRS Plate, Fixation, Bone
Cleared on Jul 22, 2020 as substantially equivalent to K113014 (Wrightmedicaltechnologyinc, 2012) after a 142-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Jul 22, 2020
- Review
- 142 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954385 (1996). 48 ancestors in all, the oldest K895117 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 2 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 1 generation backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- This deviceK200513 DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical · 2020
Show all 9 generations
- Root · 9 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 8 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 7 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 6 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 5 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 4 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 3 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 2 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 1 generation backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- This deviceK200513 DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −8 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −7 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −6 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −5 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −4 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −3 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −2 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −1 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| 0 (this device) | K200513 | DAC Dynamic Active Compression Plate | Pioneer Surgical Technology, Inc., Dba Rti Surgical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 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? (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 |
|---|---|---|---|
| * | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsSummary page 4…II Product Codes: HRS, HWC Predicate Device: Primary Predicate: Claw® II Polyaxial Compression Plating System and Ortholoc™ 3DSi Locking Screws, K113014 Reference Device: Wright Medical FuseForce™ Staple, K124045 Purpose of Submission: The purpose of this Traditional 510(k) is to s… | 2012 |
| † | K124045 | Fuseforce Implant System | 2013 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 12 of the 48 ancestors have a recall of any class.
- 1 other device also cites its predicate K113014.
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?
The DAC plate system with proprietary compression technology is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, osteotomies, arthrodeses and reconstruction of small bones of the foot such as:
• Midfoot and hindfoot arthrodeses or osteotomies
• Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocuboid, Lapidus)
• Intercuneiform arthrodeses
• Naviculocuneiform arthrodeses
• Talonavicular arthrodeses
• Calcaneocuboid arthrodeses
• Linsfranc arthrodeses
• Mono-or-bi-cortical osteotomies in the forefoot, midfoot and hindfoot
• First metatarsophalangeal arthrodeses
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200513 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200513: DAC Dynamic Active Compression Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200513
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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