510(k) · Cleared
ClearedArthrex DynaNite Nitinol Staples
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · JDR Staple, Fixation, Bone
Cleared on Jan 31, 2025 as substantially equivalent to K203180 (Arthrex, Inc., 2020) and 3 other predicates after a 58-day review. Its family tree reaches back 11 generations to 1979.
- Decided
- Jan 31, 2025
- Review
- 58 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K792022 (1979). 92 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations between
- 3 generations backK183232 Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc. · 2019
- 2 generations backK221485 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2022
- 1 generation backK230976 Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc. · 2023
- This deviceK243742 Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 9 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 8 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 7 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 6 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 5 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 4 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 3 generations backK183232 Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc. · 2019
- 2 generations backK221485 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2022
- 1 generation backK230976 Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc. · 2023
- This deviceK243742 Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −10 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −9 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −8 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −7 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −6 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −5 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −4 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −3 | K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | 2019 | — |
| −2 | K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022 | — |
| −1 | K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | 2023 | — |
| 0 (this device) | K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 12 | 0 |
| 1997 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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 |
|---|---|---|---|
| * | K203180 | Arthrex DynaNite Nitinol StaplesSummary page 5…21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class II Primary Predicate K203180 – Arthrex DynaNite Nitinol Staple Device Additional Predicate K172052 – Arthrex DynaNite Nitinol Staple Devices… | 2020 |
| * | K172052 | Arthrex DynaNite Nitinol StapleSummary page 5…fixation appliances and accessories Regulatory Class II Primary Predicate K203180 – Arthrex DynaNite Nitinol Staple Device Additional Predicate K172052 – Arthrex DynaNite Nitinol Staple Devices K232755 – Arthrex FiberTape and TigerTape Cerclage Sutures… | 2017 |
| * | K232755 | Arthrex FiberTape and TigerTape Cerclage SuturesSummary page 5…II Primary Predicate K203180 – Arthrex DynaNite Nitinol Staple Device Additional Predicate K172052 – Arthrex DynaNite Nitinol Staple Devices K232755 – Arthrex FiberTape and TigerTape Cerclage Sutures K230976 – Arthrex Radiopaque FiberTape Cerclage Suture… | 2023 |
| * | K230976 | Arthrex Radiopaque FiberTape Cerclage suturesSummary page 5…itional Predicate K172052 – Arthrex DynaNite Nitinol Staple Devices K232755 – Arthrex FiberTape and TigerTape Cerclage Sutures K230976 – Arthrex Radiopaque FiberTape Cerclage Sutures Purpose of Submission This Traditional 510(k) premarket notification is submitt… | 2023 |
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 46 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 11 of the 92 ancestors have a recall of any class.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The Arthrex DynaNite Nitinol Staple 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 Nitinol…
Read the full statement (190 words)
The Arthrex DynaNite Nitinol Staple 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 Nitinol Staples are indicated for:
» Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
» Fixation of proximal tibial metaphysis osteotomy.
» Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
» Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
» When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the “rewiring” of osteotomized sternums.
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/K243742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243742: Arthrex DynaNite Nitinol Staples.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243742
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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