510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Bioraptor 2.3 PK Suture Anchor

K071586510(k) TraditionalCleared Aug 17, 200767-day reviewClass II21 CFR 888.3040Recalls 1

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 Aug 17, 2007 as substantially equivalent to K063726 (Smith & Nephew Inc., Endoscopy Div., 2007) and 1 other predicate after a 67-day review. Its family tree reaches back 4 generations to 1996. 121 later devices descend from it. It has been recalled once.

Decided
Aug 17, 2007
Review
67 days
Class
Class II
Product code
MBI
Recalls
1
Predicates
2

Its longest line of descent runs back 4 generations to K961555 (1996). 6 ancestors in all. 121 later devices descend from it, 23 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor1998: 1 other ancestor2015: 10 descendants cleared2009: 4 descendants cleared2024: 6 descendants cleared2011: 7 descendants cleared2008: 2 descendants cleared2013: 10 descendants cleared2023: 13 descendants cleared2012: 8 descendants cleared2014: 6 descendants cleared2016: 4 descendants cleared2010: 3 descendants cleared2018: 4 descendants cleared2020: 10 descendants cleared2019: 7 descendants cleared2026: 5 descendants cleared2017: 4 descendants cleared2021: 3 descendants cleared2022: 6 descendants cleared2025: 9 descendants clearedK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 1996K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalled×2: 2 generations cleared close together, K053344 (2006), K061154 (2006) 1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 23 descendants2 generations forward: 47 descendants3 generations forward: 40 descendants4 generations forward: 9 descendants5 generations forward: 2 descendants K061154 · Kinsa Suture Anchor · Smith & Nephew, Inc. · 2006K053344 · Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor · Smith & Nephew, Inc. · 2006K031685 · Tag Rod Bioraptor Suture Anchor 7209317, 7209318 · Smith & Nephew, Inc. · 2003 · recalledK961555 · Acufex Tag Bioabsorbable Anchors · Acufex Microsurgical, Inc. · 19960+5
  1. Root · 4 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 3 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 2 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 1 generation backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
  5. This deviceK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007
  6. Descendant · cites it directly · 46 of its ownK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
  7. Descendant · cites it directly · 41 of its ownK093428 Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
  8. Descendant · cites it directly · 29 of its ownK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
  9. Descendant · cites it directly · 21 of its ownK083635 Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
  10. Descendant · 2 generations on · 16 of its ownK093844 Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010 · Recalled

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2008: 22009: 42010: 32011: 72012: 82013: 102014: 62015: 102016: 42017: 42018: 42019: 72020: 102021: 32022: 62023: 132024: 62025: 92026: 5
2008high 13 (2023) · low 2 (2008)2026

Most influential descendants

Showing 5 of 121 · See all
  • K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · cites it directly46descendants
  • K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009 · cites it directly41descendants
  • K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc. · 2012 · cites it directly29descendants
  • K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009 · cites it directly21descendants
  • K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc. · 2010 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−3K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−2K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−1K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006—
0 (this device)K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division2007—
+1K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division20089
+1K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.2009—
+1K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.2012—
+1K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.2009—
+2K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.201011

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200940
201030
201170
201280
2013100
201460
2015100
201640
201740
201840
201970
2020100
202130
202260
2023130
202460
202590
202650
FIG. 1 — Lineage of K071586, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K063726PLC Suture Anchor
Summary page 1
…ent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: BIORAPTOR 2.3 OC Suture Anchor (K063726) and KINSA Suture Anchor (K061154). E. Description of Device Non-bioabsorbable 2.3 mm suture anchor manufactured f…
Smith & Nephew Inc., Endoscopy Div.2007—
*K061154Kinsa Suture Anchor
Summary page 1
…l Scientific Technology to the following legally marketed devices in commercial distribution: BIORAPTOR 2.3 OC Suture Anchor (K063726) and KINSA Suture Anchor (K061154). E. Description of Device Non-bioabsorbable 2.3 mm suture anchor manufactured from PEEK Optima® polymer with atta…
Smith & Nephew, Inc.2006—

What descends from it? (121)

See all 121

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

NumberDeviceApplicantDecidedDescendants
K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division200846
K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.200941
K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.201229
K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.200921
K131769Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MMPivot Medical, Inc.201312
K083226Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc.20099
K102660Bioraptor Curved 2.3 PK Suture AnchorsSmith & Nephew Endoscopy, Inc.20108
K153395OS2-C Compression StapleIn2bones Sas20167
K110773Tornier Insite FT Suture AnchorTornier, Inc.20115
K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.20183

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 29, 2024Class IIZ-0581-2025Package design/selectionSterile barrier breach due to inadequate packaging design that could not hold the geometry of the 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 6 ancestors have a recall of any class.
  • Of its descendants, K082215 (Smith & Nephew Inc., Endoscopy Division, 2008) has gone furthest, with 46 descendants of its own.

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

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
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

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Hip — Hip capsule repair; Acetabutar labrum reattachment Shoulder — Capsular stabilization; Bankart repair; Anterior shoulder instability; SLAP lesion repairs; Capsular shift or capsulolabral reconstructions; Acromioclavicular separation repairs; Deltoid repairs; Rotator cuff tear repairs; Biceps tenodesis Foot and Ankle —…

Read the full statement (120 words)

The Smith & Nephew BIORAPTOR Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Hip — Hip capsule repair; Acetabutar labrum reattachment

Shoulder — Capsular stabilization; Bankart repair; Anterior shoulder instability; SLAP lesion repairs; Capsular shift or capsulolabral reconstructions; Acromioclavicular separation repairs; Deltoid repairs; Rotator cuff tear 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; PateLilar realignment and tendon repairs; Vastus medialis obliquous advancement; Iliotibial band tenodesis

Indications for use as stated in the FDA summary.

More from Smith & Nephew Inc., Endoscopy Division

8 FDA decisions under this applicant name. See the company

  • K121904Gynecology Sterilization TraySmith & Nephew Inc., Endoscopy Division · 2013
  • K102982Endobutton DirectSmith & Nephew Inc., Endoscopy Division · 2011
  • K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 20089 recalls
  • K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
  • K072785Twinfix FT PKSmith & Nephew Inc., Endoscopy Division · 2007

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K071586 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071586: Bioraptor 2.3 PK 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/K071586

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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