510(k) Report

510(k) · Cleared

Cleared

Smith and Nephew 5.00MM Absorbable Polymer Anchor

K011299510(k) TraditionalCleared Jun 27, 200158-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 Jun 27, 2001 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.

Decided
Jun 27, 2001
Review
58 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
0

48 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2015: 4 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2003: 1 descendant cleared2013: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2017: 4 descendants cleared2019: 1 descendant cleared2020: 4 descendants cleared2024: 5 descendants cleared2022: 3 descendants cleared2023: 8 descendants cleared2018: 1 descendant cleared2025: 8 descendants cleared2021: 1 descendant cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK011299 Smith and Nephew 5.00MM Absorbable Polymer AnchorSmith & Nephew, Inc. · 2001
  2. Descendant · cites it directly · 40 of its ownK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
  3. Descendant · 2 generations on · 25 of its ownK133671 Iconix All Suture AnchorsStryker Corp. · 2014
  4. Descendant · cites it directly · 20 of its ownK032197 Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211…Smith & Nephew, Inc. · 2003
  5. Descendant · cites it directly · 16 of its ownK093844 Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010 · Recalled
  6. Descendant · 2 generations on · 13 of its ownK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2003: 12010: 12011: 12012: 12013: 12014: 12015: 42017: 42018: 12019: 12020: 42021: 12022: 32023: 82024: 52025: 82026: 3
2003high 8 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 48 · See all
  • K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc. · 2011 · cites it directly40descendants
  • K133671Iconix All Suture AnchorsStryker Corp. · 2014 · 2 generations on25descendants
  • K032197Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212Smith & Nephew, Inc. · 2003 · cites it directly20descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011299Smith and Nephew 5.00MM Absorbable Polymer AnchorSmith & Nephew, Inc.2001—
+1K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.2011—
+2K133671Iconix All Suture AnchorsStryker Corp.2014—
+1K032197Twin 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201010
201110
201210
201310
201410
201540
201740
201810
201910
202040
202110
202230
202380
202450
202580
202630
FIG. 1 — Lineage of K011299, 2001–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (48)

See all 48

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

NumberDeviceApplicantDecidedDescendants
K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140
K032197Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212Smith & Nephew, Inc.200320
K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.201016
K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.20151

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?

  • Of its descendants, K110545 (Smith & Nephew, Inc., 2011) has gone furthest, with 40 descendants of its own.

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—

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/K011299 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011299: Smith and Nephew 5.00MM Absorbable Polymer Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011299

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026