510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Tag Rod Bioraptor Suture Anchor 7209317, 7209318

K031685510(k) SpecialCleared Jul 1, 200329-day reviewClass II21 CFR 888.3040Recalls 5

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

Smith & Nephew, Inc. · HWC Screw, Fixation, Bone

Cleared on Jul 1, 2003 as substantially equivalent to K961555 (Acufex Microsurgical, Inc., 1996) after a 29-day review. Its family tree reaches back 1 generation to 1996. 478 later devices descend from it. It has been recalled 5 times.

Decided
Jul 1, 2003
Review
29 days
Class
Class II
Product code
HWC
Recalls
5
Predicates
1

Its longest line of descent runs back 1 generation to K961555 (1996). 478 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2010: 14 descendants cleared2015: 21 descendants cleared2007: 10 descendants cleared2008: 7 descendants cleared2013: 28 descendants cleared2011: 27 descendants cleared2012: 16 descendants cleared2009: 14 descendants cleared2022: 22 descendants cleared2014: 30 descendants cleared2017: 19 descendants cleared2019: 26 descendants cleared2023: 50 descendants cleared2025: 33 descendants cleared2020: 38 descendants cleared2016: 14 descendants cleared2018: 23 descendants cleared2026: 32 descendants cleared2021: 22 descendants cleared2024: 29 descendants clearedK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 17 descendants3 generations forward: 67 descendants4 generations forward: 129 descendants5 generations forward: 127 descendants6 generations forward: 78 descendants7 generations forward: 36 descendants8 generations forward: 15 descendants9 generations forward: 5 descendants K961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 19960+5
  1. Root · 1 generation backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. This deviceK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003
  3. Descendant · cites it directly · 477 of its ownK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. Descendant · 2 generations on · 283 of its ownK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
  5. Descendant · 3 generations on · 227 of its ownK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
  6. Descendant · 2 generations on · 162 of its ownK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
  7. Descendant · 4 generations on · 159 of its ownK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009

Showing 5 of 478 descendants. See all descendants

Descendants cleared per year

2006: 32007: 102008: 72009: 142010: 142011: 272012: 162013: 282014: 302015: 212016: 142017: 192018: 232019: 262020: 382021: 222022: 222023: 502024: 292025: 332026: 32
2006high 50 (2023) · low 3 (2006)2026

Most influential descendants

Showing 5 of 478 · See all
  • K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSmith & Nephew, Inc. · 2006 · cites it directly477descendants
  • K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006 · 2 generations on283descendants
  • K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2007 · 3 generations on227descendants
  • K061154Kinsa Suture AnchorSmith & Nephew, Inc. · 2006 · 2 generations on162descendants
  • K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2009 · 4 generations on159descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
0 (this device)K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.2003—
+1K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
+2K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006—
+3K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…Arthrex, Inc.2007—
+2K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006—
+4K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock…Arthrex, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
2007100
200870
2009140
2010140
2011270
2012160
2013280
2014300
2015210
2016140
2017190
2018230
2019260
2020380
2021220
2022220
2023500
2024290
2025330
2026320
FIG. 1 — Lineage of K031685, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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
*K961555Acufex Tag Bioabsorbable Anchors
Summary page 1
…ic, Polyester Product Code: GAS D. Predicate Devices Acufexr" BioabsorbableTag Suture Anchors (K961555) E. Description of Device The Tag Rod BioRaptor 2.9 mm suture anchor is a push-in bioabsorable device utilized f…
Acufex Microsurgical, Inc.1996—

Also cleared against K961555: 1 other device →

What descends from it? (478)

See all 478

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSmith & Nephew, Inc.2006477
K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105
K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.20151
K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 6, 2013Class IIZ-2216-2013PackagingPinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013Class IIZ-2219-2013PackagingPinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013Class IIZ-2215-2013PackagingPinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013Class IIZ-2217-2013PackagingPinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013Class IIZ-2218-2013PackagingPinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K053344 (Smith & Nephew, Inc., 2006) has gone furthest, with 477 descendants of its own.
  • 1 other device also cites its predicate K961555.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

1. Bankart Lesion Repair

2. Rotator Cuff Repair

3. Capsular Stabilization

4. Anterior Shoulder Instability Repair

5. Repair of ligaments and tendons of the elbow, foot, and ankle including the treatment of:

- Bunionectomy

- Lateral ankle instability

- Biceps tendon reattachment

Indications for use as stated in the FDA summary.

Also cleared against K961555

1 other device cites the same predicate.

  • K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998

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

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The HWC category page

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https://510kreport.com/device/K031685 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031685: Tag Rod Bioraptor Suture Anchor 7209317, 7209318.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031685

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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