510(k) Report

510(k) · Cleared

Cleared

Smith & Nephew Healicoil PK Suture Anchor

K113294510(k) TraditionalCleared Jan 20, 201273-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 Jan 20, 2012 after a 73-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 23 later devices descend from it.

Decided
Jan 20, 2012
Review
73 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
1

23 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2015: 4 descendants cleared2025: 5 descendants cleared2013: 1 descendant cleared2020: 2 descendants cleared2019: 1 descendant cleared2024: 2 descendants cleared2022: 3 descendants cleared2021: 1 descendant cleared2023: 3 descendants cleared2017: 1 descendant cleared2010201520202025
  1. This deviceK113294 Smith & Nephew Healicoil PK Suture AnchorSmith & Nephew, Inc. · 2012
  2. Descendant · cites it directly · 10 of its ownK143745 Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc. · 2015
  3. Descendant · cites it directly · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
  5. Descendant · cites it directly · 4 of its ownK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013
  6. Descendant · 2 generations on · 2 of its ownK202763 Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. · 2021

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2013: 12015: 42017: 12019: 12020: 22021: 12022: 32023: 32024: 22025: 5
2013high 5 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 23 · See all
  • K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc. · 2015 · cites it directly10descendants
  • K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · cites it directly6descendants
  • K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · 2 generations on4descendants
  • K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013 · cites it directly4descendants
  • K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. · 2021 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K113294Smith & Nephew Healicoil PK Suture AnchorSmith & Nephew, Inc.2012—
+1K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.2015—
+1K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01…Smith & Nephew, Inc.20152
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC2019—
+1K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.2013—
+2K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201540
201710
201910
202020
202110
202230
202330
202420
202550
FIG. 1 — Lineage of K113294, 2012–2025Source: 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 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK105454Smith & Nephew Next Generation Fully Threaded PK Suture Anchor
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.201510
K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.20156
K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134
K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250
K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250

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, K143745 (Arthrex, Inc., 2015) has gone furthest, with 10 descendants of its own.

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. 2012, 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 HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor) is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Knee: Extra-capsular repairs: Medial collateral ligament…

Read the full statement (121 words)

The HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor) is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:

Bankart lesion repairs

Slap lesion repairs

Capsular shift or capsulolabral reconstructions

Acromioclavicular separation repairs

Deltoid repairs

Rotator cuff tear repairs

Biceps tenodesis

Knee:

Extra-capsular repairs:

Medial collateral ligament

Lateral collateral ligament

Posterior oblique ligament

Patellar realignment and tendon repairs:

Vastus medialis obliquous advancement

Iliotibial band tenodesis.

Foot & Ankle:

Hallux valgus repairs

Medial or lateral instability repairs/reconstructions

Achilles tendon repairs/reconstruction

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

Elbow:

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

Biceps tendon reattachment

Hip: Gluteal tendon repairs

Gluteus medius and gluteus minimus repair

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/K113294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113294: Smith & Nephew Healicoil PK Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113294

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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