510(k) · Cleared

Recalled · Class II · 2013

Smith & Nephew Twinfix Ultra HA Suture Anchor

K093844510(k) TraditionalCleared Apr 1, 2010107-day reviewClass II21 CFR 888.3030Recalls 11

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 1, 2010 as substantially equivalent to K011299 (Smith & Nephew, Inc., 2001) and 3 other predicates after a 107-day review. Its family tree reaches back 6 generations to 1996. 16 later devices descend from it. It has been recalled 11 times.

Decided: Apr 1, 2010
Review: 107 days
Class: Class II
Product code: MAI
Recalls: 11
Predicates: 4

Its longest line of descent runs back 6 generations to K961555 (1996). 13 ancestors in all. 16 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
3 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
2 generations backK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
1 generation backK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
This deviceK093844 Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010
Descendant · cites it directly · 13 of its ownK112526 Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012
Descendant · 2 generations on · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
Descendant · 2 generations on · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
Descendant · 3 generations on · 1 of its ownK222763 Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022
Descendant · 3 generations on · 1 of its ownK202153 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2012high 5 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 16 · See all

K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012 · cites it directly13descendants
K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · 2 generations on6descendants
K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · 2 generations on4descendants
K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022 · 3 generations on1descendant
K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−5	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−4	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−3	K061154	Kinsa Suture Anchor	Smith & Nephew, Inc.	2006	—
−2	K070908	Smith & Nephew Kinsa RC Suture Anchor	Smith & Nephew Inc., Endoscopy Division	2007	—
−1	K072785	Twinfix FT PK	Smith & Nephew Inc., Endoscopy Division	2007	—
0 (this device)	K093844	Smith & Nephew Twinfix Ultra HA Suture Anchor	Smith & Nephew, Inc.	2010	—
+1	K112526	Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors	Smith & Nephew, Inc.	2012	—
+2	K152566	PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01…	Smith & Nephew, Inc.	2015	2
+2	K180951	Responsive Arthroscopy Suture Anchor System	Responsive Arthroscopy, LLC	2019	—
+3	K222763	Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors	Responsive Arthroscopy, LLC	2022	—
+3	K202153	Responsive Arthroscopy Suture Anchor System	Responsive Arthroscopy, LLC	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	2	0
2003	1	0
2007	2	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2015	2	0
2017	1	0
2019	1	0
2020	2	0
2022	2	0
2023	2	0
2025	5	0

FIG. 1 — Lineage of K093844, 1996–2025Source: 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

Get a 510(k) Report

What was it cleared against? (4)

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
*	K011299	Smith and Nephew 5.00MM Absorbable Polymer Anchor Summary page 1 …hor is substantially equivalent in Intended Use and fundamental scientific technology to the following legally marketed Smith & Nephew anchors: Twinfix AR 5.0 (K01 1299), Twinfix AR 6.5 (K032 197), Twinfix FT PK (072785), and Osteoraptor (K0822 15). E. Description of Device The TWIN…	Smith & Nephew, Inc.	2001	—
*	K032197	Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212 Summary page 1 …in Intended Use and fundamental scientific technology to the following legally marketed Smith & Nephew anchors: Twinfix AR 5.0 (K01 1299), Twinfix AR 6.5 (K032 197), Twinfix FT PK (072785), and Osteoraptor (K0822 15). E. Description of Device The TWINFIX Ultra HA is a suture anchor…	Smith & Nephew, Inc.	2003	—
*	K072785	Twinfix FT PK Summary page 1 …undamental scientific technology to the following legally marketed Smith & Nephew anchors: Twinfix AR 5.0 (K01 1299), Twinfix AR 6.5 (K032 197), Twinfix FT PK (072785), and Osteoraptor (K0822 15). E. Description of Device The TWINFIX Ultra HA is a suture anchor manufactured from PLLA-H…	Smith & Nephew Inc., Endoscopy Division	2007	—
*	K082215	Osteoraptor Suture Anchor Summary page 1 …nology to the following legally marketed Smith & Nephew anchors: Twinfix AR 5.0 (K01 1299), Twinfix AR 6.5 (K032 197), Twinfix FT PK (072785), and Osteoraptor (K0822 15). E. Description of Device The TWINFIX Ultra HA is a suture anchor manufactured from PLLA-HA and is offered in d…	Smith & Nephew Inc., Endoscopy Division	2008	9

Also cleared against K011299: 3 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K112526	Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors	Smith & Nephew, Inc.	2012	13
K151105	Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…	Smith & Nephew, Inc.	2015	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 6, 2013	Class II	Z-2237-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2239-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2231-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2238-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2229-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2230-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2232-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2236-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2235-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2233-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Aug 6, 2013	Class II	Z-2240-2013	Packaging	Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
4 of the 13 ancestors have a recall of any class.
Of its descendants, K112526 (Smith & Nephew, Inc., 2012) has gone furthest, with 13 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. 2010, 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 TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Bankart 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…

Read the full statement (103 words)

The Smith & Nephew TWINFIX Ultra HA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder:

Bankart 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

fliotibial 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/K093844 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093844: Smith & Nephew Twinfix Ultra HA Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093844

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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