510(k) Report

510(k) · Cleared

Cleared

Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766 72202767 72202768 72202769 72202770

K101459510(k) TraditionalCleared Jan 27, 2011246-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, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jan 27, 2011 as substantially equivalent to K082215 (Smith & Nephew Inc., Endoscopy Division, 2008) and 1 other predicate after a 246-day review. Its family tree reaches back 6 generations to 1996. 10 later devices descend from it.

Decided
Jan 27, 2011
Review
246 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
2

Its longest line of descent runs back 6 generations to K961555 (1996). 13 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 2 other ancestors2006: 1 other ancestor2005: 1 other ancestor2001: 1 other ancestor1998: 1 other ancestor2004: 1 other ancestor2018: 2 descendants cleared2013: 1 descendant cleared2015: 2 descendants cleared2020: 1 descendant cleared2017: 1 descendant cleared2025: 2 descendants cleared2026: 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 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 4 other ancestors4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 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 deviceK101459 Osteoraptor II Suture Anchor or to BE Determined Model: 72202764…Smith & Nephew, Inc. · 2011
  8. Descendant · cites it directly · 4 of its ownK180361 MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc. · 2018
  9. Descendant · cites it directly · 4 of its ownK123393 Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013
  10. Descendant · 2 generations on · 3 of its ownK181746 MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc. · 2018
  11. Descendant · 3 generations on · 1 of its ownK251809 Arthrex FiberTak Suture AnchorArthrex, Inc. · 2025
  12. Descendant · 2 generations on · 1 of its ownK151105 Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor…Smith & Nephew, Inc. · 2015 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2013: 12015: 22017: 12018: 22020: 12025: 22026: 1
2013high 2 (2015) · low 0 (2014)2026

Most influential descendants

Showing 5 of 10 · See all
  • K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc. · 2018 · cites it directly4descendants
  • K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc. · 2013 · cites it directly4descendants
  • K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc. · 2018 · 2 generations on3descendants
  • K251809Arthrex FiberTak Suture AnchorArthrex, Inc. · 2025 · 3 generations on1descendant
  • K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc. · 2015 · 2 generations on1descendant
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)K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765…Smith & Nephew, Inc.2011—
+1K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc.2018—
+1K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.2013—
+2K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.2018—
+3K251809Arthrex FiberTak Suture AnchorArthrex, Inc.2025—
+2K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and…Smith & Nephew, Inc.201540

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
200410
200510
200610
200720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201520
201710
201820
202010
202520
202610
FIG. 1 — Lineage of K101459, 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 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? (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
*K082215Osteoraptor Suture Anchor
Summary page 1
…Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Smith & Nephew OSTEORAPTOR Suture Anchors (K0822 15) and DePuy Mitek LUPINE BR Anchor (K070925). E. Description of Device The Smith & Nephew OSTEORAPTOR OS Suture Anchor i…
Smith & Nephew Inc., Endoscopy Division20089
*K070925Modification to: Bioknotless BR Anchor / Lupine BR Anchor
Summary page 1
…nology to the following legally marketed devices in commercial distribution: Smith & Nephew OSTEORAPTOR Suture Anchors (K0822 15) and DePuy Mitek LUPINE BR Anchor (K070925). E. Description of Device The Smith & Nephew OSTEORAPTOR OS Suture Anchor is a fixation device intended to provide sec…
Depuy Mitek, A Johnson & Johnson Company200711

Also cleared against K082215: 7 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc.20184
K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134

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 3 companies; a new generation was cleared every 2.2 years on median.
  • 8 of the 13 ancestors have a recall of any class.
  • Of its descendants, K180361 (Smith and Nephew, Inc., 2018) has gone furthest, with 4 descendants 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 Osteoraptor 11 Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications: Elbow, Wrist, and Hand Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Foot and Ankle Hallux valgus repairs Medial or lateral instability repairstreconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon…

Read the full statement (125 words)

The Smith & Nephew Osteoraptor 11 Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:

Elbow, Wrist, and Hand

Biceps tendon reattachment

Ulnar or radial collateral ligament reconstructions

Lateral epicondylitis repair

Foot and Ankle

Hallux valgus repairs

Medial or lateral instability repairstreconstructions

Achilles tendon repairs/reconstructions

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

Bunionectomy

Hip

Hip capsule repair

-Acetabular labrum reattachment

Knee

Extra-capsular repairs:

- Medial collateral ligament

- Lateral collateral ligament

- Posterior oblique ligament

Patellar realignment and tendon repairs

- Vastus medialis obliquous advancement

1] lotibial band tenodesis

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

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
  • K103309Osteoraptor Curved 2.3 Suture AnchorsSmith & Nephew Endoscopy, Inc. · 2011

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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/K101459 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101459: Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766 72202767 72202768 72202769 72202770.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101459

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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