510(k) Report

510(k) · Cleared

Cleared

Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212

K032197510(k) SpecialCleared Aug 8, 200321-day reviewClass II21 CFR 888.3030

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

Smith & Nephew, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Aug 8, 2003 as substantially equivalent to K011299 (Smith & Nephew, Inc., 2001) after a 21-day review. Its family tree reaches back 1 generation to 2001. 20 later devices descend from it.

Decided
Aug 8, 2003
Review
21 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011299 (2001). 20 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2013: 1 descendant cleared2015: 3 descendants cleared2012: 1 descendant cleared2020: 3 descendants cleared2019: 1 descendant cleared2017: 1 descendant cleared2023: 2 descendants cleared2025: 5 descendants cleared2022: 2 descendants clearedK011299 · Smith and Nephew 5.00MM Absorbable Polymer Anchor · Smith & Nephew, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 9 descendants5 generations forward: 1 descendant K011299 · Smith and Nephew 5.00MM Absorbable Polymer Anchor · Smith & Nephew, Inc. · 20010+5
  1. Root · 1 generation backK011299 Smith and Nephew 5.00MM Absorbable Polymer AnchorSmith & Nephew, Inc. · 2001
  2. This deviceK032197 Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211…Smith & Nephew, Inc. · 2003
  3. Descendant · cites it directly · 16 of its ownK093844 Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010 · Recalled
  4. Descendant · 2 generations on · 13 of its ownK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
  5. Descendant · 3 generations on · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
  6. Descendant · 3 generations on · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
  7. Descendant · cites it directly · 4 of its ownK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 12015: 32017: 12019: 12020: 32022: 22023: 22025: 5
2010high 5 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 20 · See all
  • K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010 · cites it directly16descendants
  • K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012 · 2 generations on13descendants
  • K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · 3 generations on6descendants
  • K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · 3 generations on4descendants
  • K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013 · cites it directly4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011299Smith and Nephew 5.00MM Absorbable Polymer AnchorSmith & Nephew, Inc.2001—
0 (this device)K032197Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212Smith & Nephew, Inc.2003—
+1K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.201011
+2K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.2012—
+3K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01…Smith & Nephew, Inc.20152
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC2019—
+1K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
201530
201710
201910
202030
202220
202320
202550
FIG. 1 — Lineage of K032197, 2001–2025Source: 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 MAI? 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 MAI device

  1. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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
*K011299Smith and Nephew 5.00MM Absorbable Polymer AnchorSmith & Nephew, Inc.2001—

Also cleared against K011299: 3 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.201016
K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134

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?

  • Its one ancestor has no recall.
  • Of its descendants, K093844 (Smith & Nephew, Inc., 2010) has gone furthest, with 16 descendants of its own.
  • 3 other devices also cite its predicate K011299.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

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

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

Shoulder: 1. Bankart Lesion Repair 2. SLAP Lesion Repair 3. Acromioclavicular separation repairs 4. Rotator Cuff Repair 5. Capsular shift or capsulolabral reconstruction 6. Biceps tenodesis 7. Deltoid Repair Foot and Ankle: 1. Hallux Valgus repair 2. Medial or Lateral instability repaidreconstruction 3. Achilles tendon repair/reconstruction 4. Midfoot reconstruction 5. Metatarsal ligament/tendon repairs/reconstruction Elbow, Wrist, and Hand: 1.…

Read the full statement (107 words)

Shoulder:

1. Bankart Lesion Repair

2. SLAP Lesion Repair

3. Acromioclavicular separation repairs

4. Rotator Cuff Repair

5. Capsular shift or capsulolabral reconstruction

6. Biceps tenodesis

7. Deltoid Repair

Foot and Ankle:

1. Hallux Valgus repair

2. Medial or Lateral instability repaidreconstruction

3. Achilles tendon repair/reconstruction

4. Midfoot reconstruction

5. Metatarsal ligament/tendon repairs/reconstruction

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstruction

2. Ulnar or radial collateral ligament reconstruction

3. Lateral epicondylitis repair

4. Biceps tendon reattachment

Knee:

1. Extra-capsular Repairs:

la. Medial Collateral Repair

1b. Lateral Collateral Ligament

IC. Posterior Oblique Ligament

2. Iliotibial band tenodesis

3. Patellar realignment and tendon repairs, including vastus medialis obliquos -advancement

Indications for use as stated in the FDA summary.

Also cleared against K011299

3 other devices cite the same predicate.

  • K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG…Smith & Nephew, Inc. · 201540 recalls
  • K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc. · 2011
  • K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 201011 recalls

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 MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K032197 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032197: Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032197

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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