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 Aug 22, 2022 as substantially equivalent to K183232 (Smith and Nephew, Inc., 2019) after a 91-day review. Its family tree reaches back 9 generations to 1979. 5 later devices descend from it.
- Decided
- Aug 22, 2022
- Review
- 91 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K792022 (1979). 70 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 1 generation backK183232 Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc. · 2019
- This deviceK221485 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK232755 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK230976 Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK243905 Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
- 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
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 1 generation backK183232 Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc. · 2019
- This deviceK221485 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023 · cites it directly2descendants
- K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc. · 2023 · cites it directly1descendant
- K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −2 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −1 | K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | 2019 | — |
| 0 (this device) | K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2022 | — |
| +1 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023 | — |
| +1 | K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | 2023 | — |
| +1 | K243905 | Stitch Cerclage – Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | 2025 | — |
| +2 | K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape… | Arthrex, Inc. | 2025 | — |
| +2 | 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 | 1 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 3 | 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 16.5 · 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? (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 |
|---|---|---|---|
| * | K183232 | Double ENDOBUTTON Fixation DeviceSummary page 4…Fixation Cerclage 21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate Surgical Suture Regulatory Class II Predicate Device K183232 Double ENDOBUTTON Fixation Device Reference Device K170206 Arthrex FiberTape Cerclage K122374 Arth… | 2019 |
| † | K170206 | Arthrex FiberTape Cerclage | 2017 |
| † | 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 43 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 70 ancestors have a recall of any class.
- Of its descendants, K232755 (Arthrex, Inc., 2023) has gone furthest, with 2 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. 2022, 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 (109 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221485 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221485: Arthrex FiberTape and TigerTape Cerclage Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221485
Report an extraction error
Are you the manufacturer?
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