510(k) · Cleared
ClearedArthrex FiberTape Cerclage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · JDQ Cerclage, Fixation
Cleared on Nov 15, 2017 as substantially equivalent to K143716 (Dsm Biomedical, 2015) and 1 other predicate after a 295-day review. Its family tree reaches back 2 generations to 1992. 5 later devices descend from it.
- Decided
- Nov 15, 2017
- Review
- 295 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920201 (1992). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK920201 Titanium Alloy Songer Cable SystemSofamor Danek Mfg., Inc. · 1992
- 1 generation backK143716 DSM Biomedical DPR CableDsm Biomedical · 2015
- This deviceK170206 Arthrex FiberTape CerclageArthrex, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK232755 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK260018 Arthrex FiberButtonArthrex, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243344 Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque…Arthrex, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243742 Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK220765 HS Fiber CerclageRiverpoint Medical, LLC · 2023
Most influential descendants
Showing 5 of 5 · See all- K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023 · cites it directly2descendants
- K260018Arthrex FiberButtonArthrex, Inc. · 2026 · cites it directly0descendants
- K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc. · 2025 · 2 generations on0descendants
- K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025 · 2 generations on0descendants
- K220765HS Fiber CerclageRiverpoint Medical, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920201 | Titanium Alloy Songer Cable System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −1 | K143716 | DSM Biomedical DPR Cable | Dsm Biomedical | 2015 | — |
| 0 (this device) | K170206 | Arthrex FiberTape Cerclage | Arthrex, Inc. | 2017 | — |
| +1 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023 | — |
| +1 | K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026 | — |
| +2 | K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape… | Arthrex, Inc. | 2025 | — |
| +2 | K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2025 | — |
| +1 | K220765 | HS Fiber Cerclage | Riverpoint Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 JDQ? 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 JDQ device
- #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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 |
|---|---|---|---|
| * | K143716 | DSM Biomedical DPR CableSummary page 4…age 21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture Regulatory Class II Predicate Device K143716: DSM Biomedical DPR Cable Reference Predicate K102834: ISO-Elastic Cerclage System K032245:… | 2015 |
| * | K102834 | Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)Summary page 4…Poly(ethylene) Terephthalate Surgical Suture Regulatory Class II Predicate Device K143716: DSM Biomedical DPR Cable Reference Predicate K102834: ISO-Elastic Cerclage System K032245: Arthrex FiberTape Family K041553:… | 2011 |
| † | K032245 | Arthrex Fibertape (TM), 2MM, Arthrex Fibertape (TM), 3MM, Arthrex Fibertape (TM), 4MM… | 2004 |
| † | K041553 | Arthrex Suture Grafting Kit | 2004 |
| † | K122374 | Arthrex Suture (Uhmwpe) | 2012 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 3 companies; a new generation was cleared every 23.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232755 (Arthrex, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K143716.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, 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 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Arthrex FiberTape Cerclage suture is intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair. When used as a bone fixation cerclage the suture is intended for:
• Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
• Sternotomy indications including the “rewiring” of osteomized sternums.
• Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
• Repair of long bone fractures due to trauma or reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170206: Arthrex FiberTape Cerclage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170206
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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