510(k) · Cleared

Cleared

Smith & Nephew Kinsa RC Suture Anchor

K070908510(k) TraditionalCleared May 16, 200744-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., Endoscopy Division · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on May 16, 2007 as substantially equivalent to K061154 (Smith & Nephew, Inc., 2006) after a 44-day review. Its family tree reaches back 4 generations to 1996. 60 later devices descend from it.

Decided: May 16, 2007
Review: 44 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K961555 (1996). 5 ancestors in all. 60 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
3 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
2 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
1 generation backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
This deviceK070908 Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
Descendant · cites it directly · 59 of its ownK072785 Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007
Descendant · 2 generations on · 40 of its ownK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
Descendant · 3 generations on · 25 of its ownK133671 Iconix All Suture AnchorsStryker Corp. · 2014
Descendant · 2 generations on · 19 of its ownK093228 Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009
Descendant · 3 generations on · 17 of its ownK100159 Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2007high 9 (2023) · low 0 (2008)2026

Most influential descendants

Showing 5 of 60 · See all

K072785Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007 · cites it directly59descendants
K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc. · 2011 · 2 generations on40descendants
K133671Iconix All Suture AnchorsStryker Corp. · 2014 · 3 generations on25descendants
K093228Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc. · 2009 · 2 generations on19descendants
K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · 3 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−3	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−2	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−1	K061154	Kinsa Suture Anchor	Smith & Nephew, Inc.	2006	—
0 (this device)	K070908	Smith & Nephew Kinsa RC Suture Anchor	Smith & Nephew Inc., Endoscopy Division	2007	—
+1	K072785	Twinfix FT PK	Smith & Nephew Inc., Endoscopy Division	2007	—
+2	K110545	Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)	Smith & Nephew, Inc.	2011	—
+3	K133671	Iconix All Suture Anchors	Stryker Corp.	2014	—
+2	K093228	Smith & Nephew Twinfix Ultra PK Suture Anchor	Smith & Nephew, Inc.	2009	—
+3	K100159	Smith and Nephew Twinfix Ultra TI Suture Anchor	Smith & Nephew Inc., Endoscopy Div.	2010	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	2	0
2010	4	0
2011	1	0
2012	2	0
2013	1	0
2014	2	0
2015	4	0
2016	2	0
2017	4	0
2018	1	0
2019	1	0
2020	4	0
2021	1	0
2022	5	0
2023	9	0
2024	5	0
2025	8	0
2026	3	0

FIG. 1 — Lineage of K070908, 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K061154	Kinsa Suture Anchor Summary page 1 …Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew KINSA Suture Anchor (K061154). JO'7OqMS E. Descr…	Smith & Nephew, Inc.	2006	—

Also cleared against K061154: 2 other devices →

What descends from it? (60)

See all 60

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072785	Twinfix FT PK	Smith & Nephew Inc., Endoscopy Division	2007	59

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 11 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K072785 (Smith & Nephew Inc., Endoscopy Division, 2007) has gone furthest, with 59 descendants of its own.
2 other devices also cite its predicate K061154.

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. 2007, 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 KINSA RC Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Deltoid Repairs

Rotator Cuff Tear repairs

Biceps tenodesis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070908 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070908: Smith & Nephew Kinsa RC 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/K070908

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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