510(k) · Cleared
ClearedArthrex DynaNite Compression Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 8, 2020 as substantially equivalent to K161303 (Mx Orthopedics, Corp., 2017) and 1 other predicate after a 218-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Jul 8, 2020
- Review
- 218 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K964226 (1997). 20 ancestors in all, the oldest K895117 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
- 6 generations backK991482 Uni-Clip StapleNew Deal, S.A. · 1999
- 5 generations backK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
- 4 generations backK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
- 3 generations backK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled
- 2 generations backK091609 Newdeal Compression PlateNewdeal Sas · 2009 · Recalled
- 1 generation backK161303 dynaMX™ Compression PlateMx Orthopedics, Corp. · 2017
- This deviceK193345 Arthrex DynaNite Compression PlateArthrex, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K964226 | Memory Staple (20 Sizes Available) | Landos, Inc. | 1997 | — |
| −6 | K991482 | Uni-Clip Staple | New Deal, S.A. | 1999 | — |
| −5 | K011716 | The Uni-Clip Staple | New Deal, S.A. | 2001 | 1 |
| −4 | K061594 | Large Uni-Clip Staple | New Deal, S.A. | 2006 | — |
| −3 | K070447 | Newdeal Compression Plate | Newdeal Sas | 2007 | 2 |
| −2 | K091609 | Newdeal Compression Plate | Newdeal Sas | 2009 | 1 |
| −1 | K161303 | dynaMX™ Compression Plate | Mx Orthopedics, Corp. | 2017 | — |
| 0 (this device) | K193345 | Arthrex DynaNite Compression Plate | Arthrex, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K161303 | dynaMX™ Compression PlateSummary page 4…Name 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class II Predicate Device K161303: MXO dynaMX Compression Plate (Primary Predicate) K090047: Synthes (USA) 1.5mm Mini Fragment LCP System Ref… | 2017 |
| * | K090047 | Synthes (Usa) 1.5MM Mini Fragment LCP SystemSummary page 4…nces and accessories Regulatory Class II Predicate Device K161303: MXO dynaMX Compression Plate (Primary Predicate) K090047: Synthes (USA) 1.5mm Mini Fragment LCP System Reference Device K172052: Arthrex DynaNite Nitinol Staple Purpose of… | 2009 |
| † | K172052 | Arthrex DynaNite Nitinol Staple | 2017 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 20 ancestors have a recall of any class.
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 Arthrex DynaNite Compression Plate is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The Arthrex DynaNite Compression Plate is intended to be used in conjunction with the Arthrex Compression FT Screws.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193345: Arthrex DynaNite Compression Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193345
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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