510(k) Report

510(k) · Cleared

Cleared

ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device

K222971510(k) TraditionalCleared Feb 17, 2023143-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Feb 17, 2023 as substantially equivalent to K153186 (Arthrocare Corp., 2016) after a 143-day review. Its family tree reaches back 11 generations to 1990.

Decided
Feb 17, 2023
Review
143 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
1

Its longest line of descent runs back 11 generations to K904436 (1990). 65 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2011: 1 other ancestor2007: 1 other ancestor2006: 2 other ancestors2005: 2 other ancestors2004: 2 other ancestors2003: 3 other ancestors2001: 7 other ancestors1999: 5 other ancestors1998: 5 other ancestors1996: 7 other ancestors1982: 1 other ancestor1997: 3 other ancestors1994: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor2002: 2 other ancestors1995: 3 other ancestors1990: 1 other ancestor2000: 3 other ancestors1979: 1 other ancestorK904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K973015 · Multitak SS Suture System · Bonutti Research · 1997K990156 · Multitak SS Buttons · Bonutti Research · 1999K031666 · Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS · Arthrex, Inc. · 2003 · recalledK062747 · Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM · Arthrex, Inc. · 2006K100652 · Acl Tightrope · Arthrex, Inc. · 2010K112990 · Acl Tightrope,Acl Tightrope Duuble Bundle · Arthrex, Inc. · 2011K130033 · Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to · Biomet Manufacturing Corp · 2013 · recalledK133606 · N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial Implant, Various Class I Ancill · ArthroCare Corporation · 2014K153186 · Adjustable Fixation Device · Arthrocare Corp. · 201619801990200020102020
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 6 other ancestors4 generations back: 8 other ancestors5 generations back: 13 other ancestors6 generations back: 17 other ancestors7 generations back: 9 other ancestors K153186 · Adjustable Fixation Device · Arthrocare Corp. · 2016K133606 · N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial Implant, Various Class I Ancill · ArthroCare Corporation · 2014K130033 · Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to · Biomet Manufacturing Corp · 2013 · recalledK112990 · Acl Tightrope,Acl Tightrope Duuble Bundle · Arthrex, Inc. · 2011K100652 · Acl Tightrope · Arthrex, Inc. · 2010K062747 · Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM · Arthrex, Inc. · 2006K031666 · Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS · Arthrex, Inc. · 2003 · recalledK990156 · Multitak SS Buttons · Bonutti Research · 1999K973015 · Multitak SS Suture System · Bonutti Research · 1997K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990−10−50
  1. Root · 11 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
  2. 7 generations between
  3. 3 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
  4. 2 generations backK133606 N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral…ArthroCare Corporation · 2014
  5. 1 generation backK153186 Adjustable Fixation DeviceArthrocare Corp. · 2016
  6. This deviceK222971 ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB…Smith & Nephew, Inc. · 2023
Show all 11 generations
  1. Root · 11 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
  2. 10 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
  3. 9 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
  4. 8 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
  5. 7 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
  6. 6 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
  7. 5 generations backK100652 Acl TightropeArthrex, Inc. · 2010
  8. 4 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
  9. 3 generations backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
  10. 2 generations backK133606 N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral…ArthroCare Corporation · 2014
  11. 1 generation backK153186 Adjustable Fixation DeviceArthrocare Corp. · 2016
  12. This deviceK222971 ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB…Smith & Nephew, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K904436Quickanchor (TM)Mitek Surgical Products, Inc.1990—
−10K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996—
−9K973015Multitak SS Suture SystemBonutti Research1997—
−8K990156Multitak SS ButtonsBonutti Research1999—
−7K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031
−6K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006—
−5K100652Acl TightropeArthrex, Inc.2010—
−4K112990Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc.2011—
−3K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc…Biomet Manufacturing Corp20133
−2K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE…ArthroCare Corporation2014—
−1K153186Adjustable Fixation DeviceArthrocare Corp.2016—
0 (this device)K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable…Smith & Nephew, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
199010
199210
199310
199420
199530
199670
199730
199850
199950
200030
200170
200220
200330
200420
200520
200620
200710
200810
201110
FIG. 1 — Lineage of K222971, 1990–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MBI? 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 MBI device

  1. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K153186Adjustable Fixation Device
Summary page 4
…following legally marketed predicate device: Description Submission Number Clearance Date Adjustable Fixation Device K153186 January 1, 2016 Device Description The Smith & Nephew ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Dev…
Arthrocare Corp.2016—

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 33 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
  • 10 of the 65 ancestors have a recall of any class.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are indicated for soft tissue to bone or bone-tendon to bone fixation for: ACL/PCL Repair/Reconstruction and soft tissue to bone fixation for Extracapsular Repair: MCL, LCL.

Indications for use as stated in the FDA summary.

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K222971 · printed Nov 6, 2026

Cite this page

510(k) Report. “K222971: ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222971

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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