510(k) Report

510(k) · Cleared

Cleared

Bioraptor Curved 2.3 PK Suture Anchors

K102660510(k) TraditionalCleared Dec 13, 201089-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 Endoscopy, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Dec 13, 2010 as substantially equivalent to K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) after an 89-day review. Its family tree reaches back 5 generations to 1996. 8 later devices descend from it.

Decided
Dec 13, 2010
Review
89 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K961555 (1996). 7 ancestors in all. 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor1998: 1 other ancestor2015: 1 descendant cleared2016: 1 descendant cleared2023: 2 descendants cleared2025: 3 descendants cleared2022: 1 descendant 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) K071586 · Bioraptor 2.3 PK Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2007 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 6 descendants K071586 · Bioraptor 2.3 PK Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2007 · recalledK061154 · 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. · 1996−50
  1. Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 2 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
  5. 1 generation backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
  6. This deviceK102660 Bioraptor Curved 2.3 PK Suture AnchorsSmith & Nephew Endoscopy, Inc. · 2010
  7. Descendant · cites it directly · 6 of its ownK152566 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model…Smith & Nephew, Inc. · 2015 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK251627 BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid…Smith & Nephew, Inc. · 2025
  9. Descendant · 2 generations on · 0 of its ownK242477 Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025
  10. Descendant · 2 generations on · 0 of its ownK243665 Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK…ZheJiang Decans Medical Devices Co., Ltd. · 2025
  11. Descendant · 2 generations on · 0 of its ownK232725 Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd. · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12022: 12023: 22025: 3
2015high 3 (2025) · low 0 (2017)2026

Most influential descendants

Showing 5 of 8 · See all
  • K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc. · 2015 · cites it directly6descendants
  • K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc. · 2025 · 2 generations on0descendants
  • K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd. · 2025 · 2 generations on0descendants
  • K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd. · 2025 · 2 generations on0descendants
  • K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−4K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−3K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−2K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006—
−1K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division20071
0 (this device)K102660Bioraptor Curved 2.3 PK Suture AnchorsSmith & Nephew Endoscopy, Inc.2010—
+1K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01…Smith & Nephew, Inc.20152
+2K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue)…Smith & Nephew, Inc.2025—
+2K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.2025—
+2K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor…ZheJiang Decans Medical Devices Co., Ltd.2025—
+2K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
202210
202320
202530
FIG. 1 — Lineage of K102660, 1996–2025Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K071586Bioraptor 2.3 PK Suture Anchor
Summary page 1
…r Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: BIOIRAPTOR 2.3 PK Suture Anchor (K071586). Smith & Nephew Endoscopy 35 of 130 BIORAPTOR…
Smith & Nephew Inc., Endoscopy Division20071

Also cleared against K071586: 22 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.20156
K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160

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 14 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
  • 3 of the 7 ancestors have a recall of any class.
  • Of its descendants, K152566 (Smith & Nephew, Inc., 2015) has gone furthest, with 6 descendants of its own.
  • 22 other devices also cite its predicate K071586.

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

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 Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Hip Hip capsule repair - Acetabular 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…

Read the full statement (127 words)

The Smith & Nephew BIORAPTOR Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Hip

Hip capsule repair

- Acetabular 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

H-allux 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 inedialis obliquous advancement

Iliotibial band tenodesis

Indications for use as stated in the FDA summary.

Also cleared against K071586

22 other devices cite the same predicate.

  • K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew · 2024
  • K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)Smith & Nephew, Inc. · 2023
  • K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc. · 2018
  • K153395OS2-C Compression StapleIn2bones Sas · 2016
  • K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG…Smith & Nephew, Inc. · 201540 recalls
  • K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 20142 recalls

More from Smith & Nephew Endoscopy, Inc.

18 FDA decisions under this applicant name. See the company

  • K103309Osteoraptor Curved 2.3 Suture AnchorsSmith & Nephew Endoscopy, Inc. · 2011
  • K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
  • K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
  • K083226Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
  • K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008

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/K102660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102660: Bioraptor Curved 2.3 PK Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102660

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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