510(k) Report

510(k) · Cleared

Cleared

Osteoraptor Curved 2.3 Suture Anchors

K103309510(k) TraditionalCleared Feb 3, 201185-day reviewClass II21 CFR 888.3030

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. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Feb 3, 2011 as substantially equivalent to K082215 (Smith & Nephew Inc., Endoscopy Division, 2008) after an 85-day review. Its family tree reaches back 6 generations to 1996. 2 later devices descend from it.

Decided
Feb 3, 2011
Review
85 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K961555 (1996). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor1998: 1 other ancestor2015: 1 descendant cleared2017: 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 · recalledK082215 · Osteoraptor Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2008 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K082215 · Osteoraptor Suture Anchor · Smith & Nephew Inc., Endoscopy Division · 2008 · recalledK071586 · 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 · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
  2. 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
  3. 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
  4. 3 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
  5. 2 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
  6. 1 generation backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
  7. This deviceK103309 Osteoraptor Curved 2.3 Suture AnchorsSmith & Nephew Endoscopy, Inc. · 2011
  8. Descendant · cites it directly · 1 of its ownK151105 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor…Smith & Nephew, Inc. · 2015 · Recalled
  9. Descendant · 2 generations on · 0 of its ownK163672 Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc. · 2015 · cites it directly1descendant
  • K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K961555Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc.1996—
−5K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20035
−4K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…Smith & Nephew, Inc.2006—
−3K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006—
−2K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division20071
−1K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division20089
0 (this device)K103309Osteoraptor Curved 2.3 Suture AnchorsSmith & Nephew Endoscopy, Inc.2011—
+1K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and…Smith & Nephew, Inc.201540
+2K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
FIG. 1 — Lineage of K103309, 1996–2017Source: 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 MAI? 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 MAI device

  1. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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
*K082215Osteoraptor Suture Anchor
Summary page 1
…2.3 Suture Anchors are substantially equivalent in Indication for Use and Fundamental Scientific Technology to the OSTEORAPTOR 2.3 Suture Anchor, K082215. Smith & Nephew Endoscopy 34 of 126 OSTEORAPTOR Curve…
Smith & Nephew Inc., Endoscopy Division20089

Also cleared against K082215: 7 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.20151

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 4 companies; a new generation was cleared every 2.3 years on median.
  • 4 of the 8 ancestors have a recall of any class.
  • Of its descendants, K151105 (Smith & Nephew, Inc., 2015) has gone furthest, with 1 descendant of its own.
  • 7 other devices also cite its predicate K082215.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, 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 · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

The Smith & Nephew OSTERAPTOR Curved 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 (116 words)

The Smith & Nephew OSTERAPTOR Curved 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: 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.

Also cleared against K082215

7 other devices cite the same predicate.

  • K193245Dunamis PunchTac Suture AnchorsDunamis, LLC · 2020
  • K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc. · 2018
  • K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC · 2016
  • K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG…Smith & Nephew, Inc. · 201540 recalls
  • K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc. · 2012
  • K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766 72202767 72202768…Smith & Nephew, Inc. · 2011

More from Smith & Nephew Endoscopy, Inc.

18 FDA decisions under this applicant name. See the company

  • K102660Bioraptor Curved 2.3 PK Suture AnchorsSmith & Nephew Endoscopy, Inc. · 2010
  • K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
  • K083226Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
  • K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
  • K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K103309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103309: Osteoraptor Curved 2.3 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/K103309

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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