510(k) · Cleared

Cleared

Healicoil Suture Anchor with Regenesorb

K123393510(k) TraditionalCleared Apr 11, 2013160-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 Apr 11, 2013 as substantially equivalent to K113294 (Smith & Nephew, Inc., 2012) and 4 other predicates after a 160-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it.

Decided: Apr 11, 2013
Review: 160 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 5

Its longest line of descent runs back 7 generations to K961555 (1996). 19 ancestors in all. 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
4 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
3 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
2 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
1 generation backK101459 Osteoraptor II Suture Anchor or to BE Determined Model: 72202764…Smith & Nephew, Inc. · 2011
This deviceK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013
Descendant · cites it directly · 1 of its ownK151105 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor…Smith & Nephew, Inc. · 2015 · Recalled
Descendant · cites it directly · 0 of its ownK193558 HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc. · 2020
Descendant · 2 generations on · 0 of its ownK163672 Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017
Descendant · cites it directly · 0 of its ownK142948 BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · Recalled

Most influential descendants

Showing 4 of 4 · See all

K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc. · 2015 · cites it directly1descendant
K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc. · 2020 · cites it directly0descendants
K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017 · 2 generations on0descendants
K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−6	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−5	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−4	K061154	Kinsa Suture Anchor	Smith & Nephew, Inc.	2006	—
−3	K071586	Bioraptor 2.3 PK Suture Anchor	Smith & Nephew Inc., Endoscopy Division	2007	1
−2	K082215	Osteoraptor Suture Anchor	Smith & Nephew Inc., Endoscopy Division	2008	9
−1	K101459	Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765…	Smith & Nephew, Inc.	2011	—
0 (this device)	K123393	Healicoil Suture Anchor with Regenesorb	Smith & Nephew, Inc.	2013	—
+1	K151105	Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and…	Smith & Nephew, Inc.	2015	40
+1	K193558	HEALICOIL Knotless Suture Anchors	Smith & Nephew, Inc.	2020	—
+2	K163672	Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor	Nanova Biomaterials, Inc.	2017	—
+1	K142948	BIOSURE REGENESORB interference Screw	Smith & Nephew, Inc.	2015	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	2	0
2003	2	0
2004	2	0
2005	1	0
2006	1	0
2007	2	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	2	0
2017	1	0
2020	1	0

FIG. 1 — Lineage of K123393, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K113294	Smith & Nephew Healicoil PK Suture Anchor	Smith & Nephew, Inc.	2012	—
*	K101459	Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766… Summary page 1 …HEALICOIL PK Suture KI 13294 1/20/12 Inc. Anchor Smith & Nephew, Osteoraptor OS Suture KI101459 1/27/11 Inc. Anchor Smith & Nephew, TwinFix AB Anchor K032 197…	Smith & Nephew, Inc.	2011	—
*	K032197	Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212 Summary page 1 …Osteoraptor OS Suture KI101459 1/27/11 Inc. Anchor Smith & Nephew, TwinFix AB Anchor K032 197 8/8/03 Inc. DePuy Mitek Bioknotless Anchor K070925 5/2/07…	Smith & Nephew, Inc.	2003	—
*	K070925	Modification to: Bioknotless BR Anchor / Lupine BR Anchor Summary page 1 …Anchor Smith & Nephew, TwinFix AB Anchor K032 197 8/8/03 Inc. DePuy Mitek Bioknotless Anchor K070925 5/2/07 Lupine BR Anchor Linvatec Corp. Bioanchor .K042778…	Depuy Mitek, A Johnson & Johnson Company	2007	11
*	K042778	Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture Summary page 1 …Bioknotless Anchor K070925 5/2/07 Lupine BR Anchor Linvatec Corp. Bioanchor .K042778 11/4/04 Page 1/2…	Linvatec Corp.	2004	1

Also cleared against K113294: 4 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K151105	Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…	Smith & Nephew, Inc.	2015	1
K193558	HEALICOIL Knotless Suture Anchors	Smith & Nephew, Inc.	2020	0
K142948	BIOSURE REGENESORB interference Screw	Smith & Nephew, Inc.	2015	0

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 17 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
10 of the 19 ancestors have a recall of any class.
Of its descendants, K151105 (Smith & Nephew, Inc., 2015) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K113294.

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. 2013, this device’s year, is highlighted.

FDA decisions per year · MAI

8in 2025

2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	100	0	272
2008	3	83	0	172
2009	9	74	0	88
2010	4	122	0	89
2011	9	90	5	129
2012	6	56	10	171
2013	6	135	0	166
2014	4	86	0	149
2015	5	95	0	182
2016	3	191	0	301
2017	9	113	0	478
2018	13	108	0	1,590
2019	9	41	2	1,248
2020	9	78	40	957
2021	8	115	0	1,267
2022	6	136	0	1,425
2023	8	34	0	1,718
2024	7	53	0	2,300
2025	8	54	0	2,148
2026	5	69	1	—

What is it indicated for?

The Smith & Nephew HEIALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Shculder: 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…

Read the full statement (101 words)

The Smith & Nephew HEIALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Shculder:

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123393 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123393: Healicoil Suture Anchor with Regenesorb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123393

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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