510(k) · Cleared
ClearedArthrex FiberTape and TigerTape Cerclage Sutures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HTN Washer, Bolt Nut
Cleared on Oct 6, 2023 as substantially equivalent to K220947 (Arthrex, Inc., 2022) and 2 other predicates after a 28-day review. Its family tree reaches back 10 generations to 1979. 2 later devices descend from it.
- Decided
- Oct 6, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K792022 (1979). 76 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations between
- 3 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 2 generations backK183232 Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc. · 2019
- 1 generation backK221485 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2022
- This deviceK232755 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK243344 Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque…Arthrex, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243742 Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 8 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 7 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 6 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 5 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 4 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 3 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 2 generations backK183232 Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc. · 2019
- 1 generation backK221485 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2022
- This deviceK232755 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −9 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −8 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −7 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −6 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −5 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −3 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −2 | K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | 2019 | — |
| −1 | K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022 | — |
| 0 (this device) | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023 | — |
| +1 | K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape… | Arthrex, Inc. | 2025 | — |
| +1 | 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 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 HTN? 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K220947 | Arthrex Knotless AC Repair DevicesSummary page 4…21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture Regulatory Class II Primary Predicate Device K220947 Arthrex Knotless AC Repair Devices Reference Devices K221485 Arthrex FiberTape and TigerTape Cerclage… | 2022 |
| * | K221485 | Arthrex FiberTape and TigerTape Cerclage SuturesSummary page 4…Terephthalate Surgical Suture Regulatory Class II Primary Predicate Device K220947 Arthrex Knotless AC Repair Devices Reference Devices K221485 Arthrex FiberTape and TigerTape Cerclage Sutures K170206 Arthrex FiberTape… | 2022 |
| * | K170206 | Arthrex FiberTape CerclageSummary page 4…hrex Knotless AC Repair Devices Reference Devices K221485 Arthrex FiberTape and TigerTape Cerclage Sutures K170206 Arthrex FiberTape Cerclage Purpose of Submission This special 510(k) premarket notification is submitted… | 2017 |
What descends from it? (2)
2 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 44 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 76 ancestors have a recall of any class.
- Of its descendants, K243344 (Arthrex, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Arthrex FiberTape and TigerTape Cerclage Sutures are 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 bone fixation cerclage the sutures are intended for: * Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty * Sternotomy indications…
Read the full statement (132 words)
Arthrex FiberTape and TigerTape Cerclage Sutures are 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 bone fixation cerclage the sutures are 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
- Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).
* Repair of long bone fractures due to trauma or reconstruction
* To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
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/K232755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232755: Arthrex FiberTape and TigerTape Cerclage Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232755
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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