510(k) · Cleared

Cleared

Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an

K121018510(k) TraditionalCleared Jun 22, 201279-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 22, 2012 as substantially equivalent to K053344 (Smith & Nephew, Inc., 2006) and 3 other predicates after a 79-day review. Its family tree reaches back 6 generations to 1996. 29 later devices descend from it.

Decided: Jun 22, 2012
Review: 79 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 4

Its longest line of descent runs back 6 generations to K961555 (1996). 14 ancestors in all. 29 later devices descend from it, 9 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 backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
1 generation backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
This deviceK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
Descendant · cites it directly · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
Descendant · cites it directly · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
Descendant · cites it directly · 4 of its ownK143660 Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
Descendant · cites it directly · 2 of its ownK182507 Tigon Medical Tissue AnchorsTigon Medical · 2019
Descendant · cites it directly · 2 of its ownK181076 Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2013high 6 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 29 · See all

K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · cites it directly6descendants
K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · cites it directly4descendants
K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015 · cites it directly4descendants
K182507Tigon Medical Tissue AnchorsTigon Medical · 2019 · cites it directly2descendants
K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019 · cites it directly2descendants

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	K071586	Bioraptor 2.3 PK Suture Anchor	Smith & Nephew Inc., Endoscopy Division	2007	1
−1	K082215	Osteoraptor Suture Anchor	Smith & Nephew Inc., Endoscopy Division	2008	9
0 (this device)	K121018	Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an	Smith & Nephew, Inc.	2012	—
+1	K152566	PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01…	Smith & Nephew, Inc.	2015	2
+1	K180951	Responsive Arthroscopy Suture Anchor System	Responsive Arthroscopy, LLC	2019	—
+1	K143660	Milagro / Milagro Advance Interference Screw	Depuy Mitek, A Johnson & Johnson Company	2015	—
+1	K182507	Tigon Medical Tissue Anchors	Tigon Medical	2019	—
+1	K181076	Responsive Arthroscopy Wedge Push-In Suture Anchors	Responsive Arthroscopy, LLC	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
2000	1	0
2001	1	0
2005	1	0
2007	1	0
2008	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0
2015	2	0
2016	1	0
2017	1	0
2019	4	0
2020	1	0
2021	2	0
2022	2	0
2023	5	0
2024	2	0
2025	6	0
2026	1	0

FIG. 1 — Lineage of K121018, 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? (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
*	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor Summary page 1 …ORAPTOO 2.9, BIORAPTOR0 2.3 PKC, OSTEORAPTOR0, and 0 BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K(082215, and K(093428, respectively, and have identical indications for use. Smith &Nephew, Inc. seeks to expand the e…	Smith & Nephew, Inc.	2006	—
*	K071586	Bioraptor 2.3 PK Suture Anchor Summary page 1 ….9, BIORAPTOR0 2.3 PKC, OSTEORAPTOR0, and 0 BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K(082215, and K(093428, respectively, and have identical indications for use. Smith &Nephew, Inc. seeks to expand the existing i…	Smith & Nephew Inc., Endoscopy Division	2007	1
*	K082215	Osteoraptor Suture Anchor Summary page 2 …nc. Smith &Nephew, Inc. 8IORAPTOR' 2.3 PK Suture Anchors K071586 08/17/2007 Smith &Nephew, Inc. OSTEORAPTORO Suture Anchors K082215 11/03/2008 Smith &Nephew, Inc. BIORAPTOr Knotiess Suture Anchors K093428 12/17/2009…	Smith & Nephew Inc., Endoscopy Division	2008	9
*	K093428	Smith & Nephew Knotless Instability Anchor Summary page 2 …007 Smith &Nephew, Inc. OSTEORAPTORO Suture Anchors K082215 11/03/2008 Smith &Nephew, Inc. BIORAPTOr Knotiess Suture Anchors K093428 12/17/2009 2 === P…	Smith & Nephew Endoscopy, Inc.	2009	—

Also cleared against K053344: 15 other devices →

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K152566	PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…	Smith & Nephew, Inc.	2015	6
K180951	Responsive Arthroscopy Suture Anchor System	Responsive Arthroscopy, LLC	2019	4
K143660	Milagro / Milagro Advance Interference Screw	Depuy Mitek, A Johnson & Johnson Company	2015	4
K182507	Tigon Medical Tissue Anchors	Tigon Medical	2019	2
K181076	Responsive Arthroscopy Wedge Push-In Suture Anchors	Responsive Arthroscopy, LLC	2019	2
K212381	VersaTap, VersaLat, DueLock, VersaTi, MiniTi	Ortho-Design (Pty), Ltd.	2021	1
K132241	Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…	Depuy Mitek, A Johnson & Johnson Company	2013	1
K231002	Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…	Suzhou Endophix Co., Ltd.	2023	0
K172491	ICONN Square 2.5MM Suture Anchor	Iconn Orthopedics, LLC	2017	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 16 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
5 of the 14 ancestors have a recall of any class.
Of its descendants, K152566 (Smith & Nephew, Inc., 2015) has gone furthest, with 6 descendants of its own.
15 other devices also cite its predicate K053344.

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. 2012, 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 Suture Anchors are intended for the, reattachment of soft tissue to bone for the following indications: Hip Hip capsule repair Acetabular labrum reattachment/reconstruction Shoulder Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator Cuff repairs Biceps Tenodesis Foot and Ankle Hallux valgus…

Read the full statement (113 words)

The Smith & Nephew Suture Anchors are intended for the, reattachment of soft tissue to bone for the following indications:

Hip

Hip capsule repair

Acetabular labrum reattachment/reconstruction

Shoulder

Capsular stabilization

Bankart repair

Anterior shoulder instability

SLAP lesion repairs

Capsular shift or capsulolabral reconstructions

Acromioclavicular separation repairs

Deltoid repairs

Rotator Cuff repairs

Biceps Tenodesis

Foot and Ankle

Hallux valgus repairs

Medial or lateral instability repairs/reconstructions

Achilles tendon repairs/reconstructions

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

Bunionectomy

Elbow, Wrist, and Hand

Biceps tendon reattachment

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121018: Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121018

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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