510(k) · Cleared

Recalled · Class II · 2012

Smith and Nephew Twinfix Ultra TI Suture Anchor

K100159510(k) TraditionalCleared Apr 19, 201089-day reviewClass II21 CFR 888.3040Recalls 4

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

Smith & Nephew Inc., Endoscopy Div. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Apr 19, 2010 as substantially equivalent to K093228 (Smith & Nephew, Inc., 2009) and 1 other predicate after an 89-day review. Its family tree reaches back 7 generations to 1996. 17 later devices descend from it. It has been recalled 4 times.

Decided: Apr 19, 2010
Review: 89 days
Class: Class II
Product code: MBI
Recalls: 4
Predicates: 2

Its longest line of descent runs back 7 generations to K961555 (1996). 9 ancestors in all. 17 later devices descend from it, 4 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 backK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
2 generations backK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
1 generation backK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
This deviceK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 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 17 descendants. See all descendants

Descendants cleared per year

2012high 5 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 17 · 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
−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	K070908	Smith & Nephew Kinsa RC Suture Anchor	Smith & Nephew Inc., Endoscopy Division	2007	—
−2	K072785	Twinfix FT PK	Smith & Nephew Inc., Endoscopy Division	2007	—
−1	K093228	Smith & Nephew Twinfix Ultra PK Suture Anchor	Smith & Nephew, Inc.	2009	—
0 (this device)	K100159	Smith and Nephew Twinfix Ultra TI Suture Anchor	Smith & Nephew Inc., Endoscopy Div.	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	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2015	1	0
2016	1	0
2019	1	0
2020	3	0
2022	2	0
2023	2	0
2025	5	0

FIG. 1 — Lineage of K100159, 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 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 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (2)

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
*	K093228	Smith & Nephew Twinfix Ultra PK Suture Anchor Our reading of the summary gave K093226, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Smith & Nephew TWINFIX Ultra PK Suture Anchor”.	Smith & Nephew, Inc.	2009	—
*	K972326	Peba Anchor/Suture Combination Summary page 1 …tific technology to the legally marketed Smith & Nephew TWTNFIX Ultra PK Suture Anchor cleared via K093226 and the TWINFIX Ti 5.0 Suture Anchor cleared via K972326. E. Description of Device The TW[NFIIX Ultra Ti is a suture anchor manufactured from Titanium alloy and is offe…	Orthopaedic Biosystems, Ltd.	1998	1

Also cleared against K093228: 2 other devices →

What descends from it? (17)

See all 17

4 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
K120356	NCS Fish-Fit MD System Fish-Fit MD Compass MD	Ncs Lab Srl	2012	1
K232725	Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor	Suzhou Endophix Co., Ltd.	2023	0
K193558	HEALICOIL Knotless Suture Anchors	Smith & Nephew, Inc.	2020	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 3, 2012	Class II	Z-2165-2012	Device Design	Distal part of the anchor may break on insertion into bone during surgery
Jul 3, 2012	Class II	Z-2166-2012	Device Design	Distal part of the anchor may break on insertion into bone during surgery
Jul 3, 2012	Class II	Z-2167-2012	Device Design	Distal part of the anchor may break on insertion into bone during surgery
Jul 3, 2012	Class II	Z-2168-2012	Device Design	Distal part of the anchor may break on insertion into bone during surgery

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 11 months on median.
2 of the 9 ancestors have a recall of any class.
Of its descendants, K112526 (Smith & Nephew, Inc., 2012) has gone furthest, with 13 descendants of its own.
2 other devices also cite its predicate K093228.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

What is it indicated for?

The Smith & Nephew TWINFIX Ultra Ti 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 Acromnioclavicular 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 (104 words)

The Smith & Nephew TWINFIX Ultra Ti 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

Acromnioclavicular 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

lliotibial band tenodesis.

Foot & Ankle:

Hallux valgus repairs

Medial or lateral instability repairs/reconstructions

Achilles tendon repairs/reconstruction

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructionls

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/K100159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100159: Smith and Nephew Twinfix Ultra TI 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/K100159

Report an extraction error

Are you the manufacturer?

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