510(k) · Cleared

Cleared

Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)

K110545510(k) TraditionalCleared Jun 24, 2011119-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 Jun 24, 2011 as substantially equivalent to K072785 (Smith & Nephew Inc., Endoscopy Division, 2007) and 2 other predicates after a 119-day review. Its family tree reaches back 7 generations to 1996. 40 later devices descend from it.

Decided: Jun 24, 2011
Review: 119 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 3

Its longest line of descent runs back 7 generations to K961555 (1996). 14 ancestors in all. 40 later devices descend from it, 2 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 backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
2 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
1 generation backK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
This deviceK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
Descendant · cites it directly · 25 of its ownK133671 Iconix All Suture AnchorsStryker Corp. · 2014
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 · 10 of its ownK151201 Stryker ICONIX with NeedlesStryker · 2015
Descendant · 2 generations on · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
Descendant · 3 generations on · 5 of its ownK173074 ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2012high 8 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 40 · See all

K133671Iconix All Suture AnchorsStryker Corp. · 2014 · cites it directly25descendants
K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc. · 2012 · cites it directly13descendants
K151201Stryker ICONIX with NeedlesStryker · 2015 · 2 generations on10descendants
K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · 2 generations on6descendants
K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018 · 3 generations on5descendants

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	K061863	Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family	Arthrex, Inc.	2006	—
−3	K071177	Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…	Arthrex, Inc.	2007	—
−2	K082810	Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock…	Arthrex, Inc.	2009	—
−1	K101823	Arthrex Swivelock Anchors	Arthrex, Inc.	2011	6
0 (this device)	K110545	Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)	Smith & Nephew, Inc.	2011	—
+1	K133671	Iconix All Suture Anchors	Stryker Corp.	2014	—
+1	K112526	Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors	Smith & Nephew, Inc.	2012	—
+2	K151201	Stryker ICONIX with Needles	Stryker	2015	—
+2	K152566	PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01…	Smith & Nephew, Inc.	2015	2
+3	K173074	ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor	Stryker	2018	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2014	1	0
2015	2	0
2017	3	0
2018	1	0
2019	1	0
2020	3	0
2021	1	0
2022	3	0
2023	8	0
2024	5	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K110545, 1996–2026Source: 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? (3)

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
*	K072785	Twinfix FT PK Summary page 1 …antially eqnivalent in intended use and fundamental scientific technology to the following legally marketed suture anchors: Smith & Nephew TWINFD( FT PK (K072785), Smith & Nephew TWINFIX AB 5.0 (K(01 1299) and Artlrex. Swiveock (K10 1823). E. Description of Device…	Smith & Nephew Inc., Endoscopy Division	2007	—
*	K011299	Smith and Nephew 5.00MM Absorbable Polymer Anchor Summary page 2 …the Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor is substantially equivalent to the predicate TWINFIX AB 5.0 suture anchor, cleared via 510(k) K(011299. The testing demonstrates that the differences between the new device and the predicate device do not raise any new issue…	Smith & Nephew, Inc.	2001	—
*	K101823	Arthrex Swivelock Anchors Summary page 1 …o the following legally marketed suture anchors: Smith & Nephew TWINFD( FT PK (K072785), Smith & Nephew TWINFIX AB 5.0 (K(01 1299) and Artlrex. Swiveock (K10 1823). E. Description of Device The Next Generation Fully Threaded PEEK Suture Anchor is manufactured from PEEK…	Arthrex, Inc.	2011	6

Also cleared against K072785: 5 other devices →

What descends from it? (40)

See all 40

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

Number	Device	Applicant	Decided	Descendants
K133671	Iconix All Suture Anchors	Stryker Corp.	2014	25
K112526	Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors	Smith & Nephew, Inc.	2012	13

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 15 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
3 of the 14 ancestors have a recall of any class.
Of its descendants, K133671 (Stryker Corp., 2014) has gone furthest, with 25 descendants of its own.
5 other devices also cite its predicate K072785.

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. 2011, 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 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…

Read the full statement (116 words)

The 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 mnedialis 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.

https://510kreport.com/device/K110545 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110545: Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110545

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