510(k) Report

510(k) · Cleared

Cleared

Milagro Interference Screws

K122869510(k) TraditionalCleared Dec 13, 201285-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

Depuy Mitek, A Johnson & Johnson Company · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Dec 13, 2012 as substantially equivalent to K120589 (Depuy Mitek, A Johnson & Johnson Company, 2012) and 6 other predicates after an 85-day review. Its family tree reaches back 10 generations to 1994.

Decided
Dec 13, 2012
Review
85 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
7

Its longest line of descent runs back 10 generations to K933738 (1994). 44 ancestors in all, the oldest K895711 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2004: 2 other ancestors2002: 2 other ancestors2001: 3 other ancestors2007: 1 other ancestor2000: 2 other ancestors1999: 4 other ancestors1998: 4 other ancestors1997: 1 other ancestor1995: 4 other ancestors1994: 2 other ancestors1996: 5 other ancestors1990: 1 other ancestorK933738 · M. Kurosaka Interference Fixation Screw · Depuy, Inc. · 1994 · recalledK955733 · Hyloc Interference Screw (Cannulated)/(Non-Cannulated) · Depuy, Inc. · 1996×2: 2 generations cleared close together, K980440 (1998), K981670 (1998) K982662 · Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference Screw · DePuy Orthopaedics, Inc. · 1998 · recalledK993073 · Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 · Bionx Implants, Ltd. · 1999K032894 · Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, · Linvatec Biomaterials, Inc. · 2004K052080 · Matryx Interference Screw · Linvatec Biomaterials, Inc. · 2005K102410 · Matryx Interference Screw (5.0-6.5MM) · Conmed Linvatec · 2010K120589 · Milagro Interference Screws · Depuy Mitek, A Johnson & Johnson Company · 201219901995200020052010
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 2 other ancestors3 generations back: 5 other ancestors4 generations back: 5 other ancestors5 generations back: 10 other ancestors6 generations back: 6 other ancestors K120589 · Milagro Interference Screws · Depuy Mitek, A Johnson & Johnson Company · 2012K102410 · Matryx Interference Screw (5.0-6.5MM) · Conmed Linvatec · 2010K052080 · Matryx Interference Screw · Linvatec Biomaterials, Inc. · 2005K032894 · Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, · Linvatec Biomaterials, Inc. · 2004K993073 · Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 · Bionx Implants, Ltd. · 1999K982662 · Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference Screw · DePuy Orthopaedics, Inc. · 1998 · recalledK981670 · Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw · Depuy, Inc. · 1998K980440 · Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw · Depuy, Inc. · 1998K955733 · Hyloc Interference Screw (Cannulated)/(Non-Cannulated) · Depuy, Inc. · 1996K933738 · M. Kurosaka Interference Fixation Screw · Depuy, Inc. · 1994 · recalled−10−50
  1. Root · 10 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
  2. 6 generations between
  3. 3 generations backK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
  4. 2 generations backK102410 Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec · 2010
  5. 1 generation backK120589 Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company · 2012
  6. This deviceK122869 Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company · 2012
Show all 10 generations
  1. Root · 10 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
  2. 9 generations backK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
  3. 8 generations backK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
  4. 7 generations backK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
  5. 6 generations backK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998 · Recalled
  6. 5 generations backK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
  7. 4 generations backK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
  8. 3 generations backK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
  9. 2 generations backK102410 Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec · 2010
  10. 1 generation backK120589 Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company · 2012
  11. This deviceK122869 Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K933738M. Kurosaka Interference Fixation ScrewDepuy, Inc.19942
−9K955733Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc.1996—
−8K980440Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc.1998—
−7K981670Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable…Depuy, Inc.1998—
−6K982662Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable…DePuy Orthopaedics, Inc.19984
−5K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020…Bionx Implants, Ltd.1999—
−4K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T…Linvatec Biomaterials, Inc.2004—
−3K052080Matryx Interference ScrewLinvatec Biomaterials, Inc.2005—
−2K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec2010—
−1K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company2012—
0 (this device)K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199420
199540
199650
199710
199840
199940
200020
200130
200220
200420
200510
200610
200710
201110
FIG. 1 — Lineage of K122869, 1994–2012Source: 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
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What was it cleared against? (7)

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
*K120589Milagro Interference Screws
Summary page 2
…tions of the proposed DePuy Mitek Milagro® Interference Screws are substantially equivalent to the existing DePuy Mitek Milagro® Interference Screws cleared under 510(k) K120589, K(103831, K060830 and K(032717 except that the proposed DePuy Mitek MilagroO Interference Screws are smaller in size. Technologi…
Depuy Mitek, A Johnson & Johnson Company2012—
*K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809
Summary page 2
…ntical to that used for the currently marketed DePuy Mitek Milagro® Interference Screw (previously c/eared by the FDA under the premarket notification K03271 7, K060830, K103831 and K(120.589). NONCLINICAL TESTING Product Design Verification activities, such as, Insertion Torque, Anchor Pullout (at T=0,…
Depuy Mitek, A Johnson & Johnson Company2011—
*K060830Milagro Interference Screw
Summary page 2
…ed DePuy Mitek Milagro® Interference Screws are substantially equivalent to the existing DePuy Mitek Milagro® Interference Screws cleared under 510(k) K120589, K(103831, K060830 and K(032717 except that the proposed DePuy Mitek MilagroO Interference Screws are smaller in size. Technological characteristics…
Depuy Mitek, A Johnson & Johnson Company2006—
*K032717Biocryl Rapide Interference Screw
Summary page 1
…L EQUIVALENCE The proposed 6, 7 and 8 xl5mm DePuy Mitek MilagroO Interference Screws are substantially equivalent to the following devices. " 1(120589,Kl(13831,K1(60830, K032717: Milagro Interference Screws " 1(051726,1(041356,1(020043: Arthrex Tenodesis Screws FDA PRODUCT CODE MAI, HWC…
Mitek Worldwide2004—
*K051726Arthrex Tenodesis Family
Summary page 1
…ePuy Mitek MilagroO Interference Screws are substantially equivalent to the following devices. " 1(120589,Kl(13831,K1(60830, K032717: Milagro Interference Screws " 1(051726,1(041356,1(020043: Arthrex Tenodesis Screws FDA PRODUCT CODE MAI, HWC DEVICE CLASSIFICATION This type of fixation…
Arthrex, Inc.2005—
*K041356Arthrex Tenodesis Screw Family
Summary page 1
…k MilagroO Interference Screws are substantially equivalent to the following devices. " 1(120589,Kl(13831,K1(60830, K032717: Milagro Interference Screws " 1(051726,1(041356,1(020043: Arthrex Tenodesis Screws FDA PRODUCT CODE MAI, HWC DEVICE CLASSIFICATION This type of fixation screw was…
Arthrex, Inc.2004—
*K0200434.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw…
Summary page 1
…O Interference Screws are substantially equivalent to the following devices. " 1(120589,Kl(13831,K1(60830, K032717: Milagro Interference Screws " 1(051726,1(041356,1(020043: Arthrex Tenodesis Screws FDA PRODUCT CODE MAI, HWC DEVICE CLASSIFICATION This type of fixation screw was original…
Arthrex, Inc.2002—

What descends from it?

No later submission names this one as a predicate yet.

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 18 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 3 of the 44 ancestors have a recall of any class.

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. 2012, 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 DePuy Mitek MILAGRO BR Interference Screws are designed to attach soft tissues to bone in orthopedic surgical procedures for following indications:

Shoulder: Proximal Biceps Tenodesis, Acromlio-Clavicular Repair

Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament repair

Knee: Collateral Ligament Repair

Indications for use as stated in the FDA summary.

More from Depuy Mitek, A Johnson & Johnson Company

58 FDA decisions under this applicant name. See the company

  • K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
  • K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company · 2014
  • K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek Anchor with Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor…Depuy Mitek, A Johnson & Johnson Company · 2014

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The MAI category page

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https://510kreport.com/device/K122869 · printed Nov 5, 2026

Cite this page

510(k) Report. “K122869: Milagro Interference Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122869

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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