510(k) Report

510(k) · Cleared

Cleared

Magnum MP Fixation Device

K091503510(k) SpecialCleared Jun 17, 200927-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

Arthrocare Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jun 17, 2009 as substantially equivalent to K070227 (Arthrocare Corp., 2007) after a 27-day review. Its family tree reaches back 4 generations to 1992.

Decided
Jun 17, 2009
Review
27 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K921873 (1992). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors2005: 1 other ancestor2004: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestorK921873 · Quickanchor, Modification · Mitek Surgical Products, Inc. · 1992K992487 · Mitek Mini Quickanchor Plus · Mitek Products · 1999K061349 · Opus Labralock P Knotless Fixation Device · Arthrocare Corp. · 2006K070227 · Opus Magnum PI Knotless Fixation Device · Arthrocare Corp. · 200719901995200020052010
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 4 other ancestors K070227 · Opus Magnum PI Knotless Fixation Device · Arthrocare Corp. · 2007K061349 · Opus Labralock P Knotless Fixation Device · Arthrocare Corp. · 2006K992487 · Mitek Mini Quickanchor Plus · Mitek Products · 1999K921873 · Quickanchor, Modification · Mitek Surgical Products, Inc. · 19920
  1. Root · 4 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
  2. 3 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
  3. 2 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
  4. 1 generation backK070227 Opus Magnum PI Knotless Fixation DeviceArthrocare Corp. · 2007
  5. This deviceK091503 Magnum MP Fixation DeviceArthrocare Corp. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K921873Quickanchor, ModificationMitek Surgical Products, Inc.1992—
−3K992487Mitek Mini Quickanchor PlusMitek Products1999—
−2K061349Opus Labralock P Knotless Fixation DeviceArthrocare Corp.2006—
−1K070227Opus Magnum PI Knotless Fixation DeviceArthrocare Corp.2007—
0 (this device)K091503Magnum MP Fixation DeviceArthrocare Corp.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199710
200010
200120
200410
200510
FIG. 1 — Lineage of K091503, 1992–2009Source: 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
*K070227Opus Magnum PI Knotless Fixation Device
Summary page 1
…(Class II per 21 CFR 888.3040, Product code: MBI) Predicate Devices Opus Magnum PI K070227 (Cleared April 16, 2007) Product Description The Magnum MP device is a bone anchor system with inserter hand…
Arthrocare Corp.2007—

Also cleared against K070227: 3 other devices →

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 17 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K070227.

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. 2009, 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 Magnum MP bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus…

Read the full statement (93 words)

The Magnum MP bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment.

Knee:: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction,. ITB tenodesis; patellar ligament and tendon avulsions

Indications for use as stated in the FDA summary.

Also cleared against K070227

3 other devices cite the same predicate.

  • K083240Opus MAGNUM2 and Opus Magnum X Knotless Fixation DevicesArthrocare Corp. · 20093 recalls
  • K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008
  • K080335Tornier Cinch Knotless Fixation Implant SystemTornier, Inc. · 2008

More from Arthrocare Corp.

112 FDA decisions under this applicant name. See the company

  • K153186Adjustable Fixation DeviceArthrocare Corp. · 2016
  • K131709Sinus Dilation System with Cannulated InstrumentArthrocare Corp. · 2013
  • K130196Speedlock Knotless Fixation Device, 3MM Drill, 3MM+ Drill, Pathfinder Obturator & Sharp Tipped Obturator…Arthrocare Corp. · 2013
  • K111399Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low Profile Drill Guide…Arthrocare Corp. · 2011
  • K111397Titan TI Suture Anchor SystemArthrocare Corp. · 2011

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/K091503 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091503: Magnum MP Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091503

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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