510(k) · Cleared
ClearedMultifix S Knotless Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthocare Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 29, 2013 as substantially equivalent to K120096 (ArthroCare Corporation, 2012) and 2 other predicates after a 94-day review. Its family tree reaches back 7 generations to 1996. 9 later devices descend from it.
- Decided
- Jul 29, 2013
- Review
- 94 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K961555 (1996). 21 ancestors in all, the oldest K921873 (1992). 9 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK081893 Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp. · 2008
- 2 generations backK100457 Opus Speedscrew SystemArthrocare Corp. · 2010
- 1 generation backK101448 Opus Speedscrew SystemArthrocare Corp. · 2010 · Recalled
- This deviceK131182 Multifix S Knotless Fixation DeviceArthocare Corporation · 2013
- Descendant · cites it directly · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
- Descendant · cites it directly · 3 of its ownK132590 5.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless…ArthroCare Corporation · 2013
- Descendant · 2 generations on · 2 of its ownK140604 Multifix S Knotless Fixation SystemArthroCare Corporation · 2014
- Descendant · 2 generations on · 1 of its ownK222763 Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK202153 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · cites it directly4descendants
- K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation · 2013 · cites it directly3descendants
- K140604Multifix S Knotless Fixation SystemArthroCare Corporation · 2014 · 2 generations on2descendants
- K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022 · 2 generations on1descendant
- K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K081893 | Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500 | Arthrocare Corp. | 2008 | — |
| −2 | K100457 | Opus Speedscrew System | Arthrocare Corp. | 2010 | — |
| −1 | K101448 | Opus Speedscrew System | Arthrocare Corp. | 2010 | 1 |
| 0 (this device) | K131182 | Multifix S Knotless Fixation Device | Arthocare Corporation | 2013 | — |
| +1 | K180951 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2019 | — |
| +1 | K132590 | 5.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation… | ArthroCare Corporation | 2013 | — |
| +2 | K140604 | Multifix S Knotless Fixation System | ArthroCare Corporation | 2014 | — |
| +2 | K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors | Responsive Arthroscopy, LLC | 2022 | — |
| +2 | K202153 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
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 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120096 | Multifix P Knotless Fixation DeviceSummary page 1…vice Class: Class 11 Product Code: MBI CER Section: 21 CFR 888.3040 Predicate Devices ArthroCare MultiFIX P Knotless Fixation Device: K120096 (cleared March 27, 2012) ArthroCare 5.5 mm SpeedScrew® Knotless Fixation-Device: K081893 (cleared October 1, 2008) ArthroCare 6.5… | 2012 |
| * | K081893 | Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Summary page 1…888.3040 Predicate Devices ArthroCare MultiFIX P Knotless Fixation Device: K120096 (cleared March 27, 2012) ArthroCare 5.5 mm SpeedScrew® Knotless Fixation-Device: K081893 (cleared October 1, 2008) ArthroCare 6.5min SpeedScrew' Knotless Fixation Device: Kl101448 (cleared Junie 21. 20 10) Descriptio… | 2008 |
| * | K101448 | Opus Speedscrew SystemSummary page 2…cs Proposed Desvice NiultiFIX P SpeedScrew Multi]FiX S (1(120096) (1(081893, K101448) Intended Use Fixation of'soft tissue to Same Same… | 2010 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K180951 (Responsive Arthroscopy, LLC, 2019) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K120096.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The MultiFIX S 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…
Read the full statement (89 words)
The MultiFIX S 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 reattachment
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.
https://510kreport.com/device/K131182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131182: Multifix S Knotless 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/K131182
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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