510(k) · Cleared
ClearedMultifix P Knotless Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ArthroCare Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 27, 2012 as substantially equivalent to K061349 (Arthrocare Corp., 2006) after a 75-day review. Its family tree reaches back 3 generations to 1992. 11 later devices descend from it.
- Decided
- Mar 27, 2012
- Review
- 75 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921873 (1992). 11 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
- 2 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
- 1 generation backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
- This deviceK120096 Multifix P Knotless Fixation DeviceArthroCare Corporation · 2012
- Descendant · cites it directly · 9 of its ownK131182 Multifix S Knotless Fixation DeviceArthocare Corporation · 2013
- Descendant · 2 generations on · 4 of its ownK180951 Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
- Descendant · 2 generations on · 3 of its ownK132590 5.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless…ArthroCare Corporation · 2013
- Descendant · 3 generations on · 2 of its ownK140604 Multifix S Knotless Fixation SystemArthroCare Corporation · 2014
- Descendant · 3 generations on · 1 of its ownK222763 Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K131182Multifix S Knotless Fixation DeviceArthocare Corporation · 2013 · cites it directly9descendants
- K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019 · 2 generations on4descendants
- K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation · 2013 · 2 generations on3descendants
- K140604Multifix S Knotless Fixation SystemArthroCare Corporation · 2014 · 3 generations on2descendants
- K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921873 | Quickanchor, Modification | Mitek Surgical Products, Inc. | 1992 | — |
| −2 | K992487 | Mitek Mini Quickanchor Plus | Mitek Products | 1999 | — |
| −1 | K061349 | Opus Labralock P Knotless Fixation Device | Arthrocare Corp. | 2006 | — |
| 0 (this device) | K120096 | Multifix P Knotless Fixation Device | ArthroCare Corporation | 2012 | — |
| +1 | K131182 | Multifix S Knotless Fixation Device | Arthocare Corporation | 2013 | — |
| +2 | K180951 | Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC | 2019 | — |
| +2 | K132590 | 5.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation… | ArthroCare Corporation | 2013 | — |
| +3 | K140604 | Multifix S Knotless Fixation System | ArthroCare Corporation | 2014 | — |
| +3 | K222763 | Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors | Responsive Arthroscopy, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061349 | Opus Labralock P Knotless Fixation DeviceSummary page 1…Classification:. Class 11 Product Code: MBI CFR Section: 21 CFR 888.3040 Predicate Device ArthroCare LabraLock® P Knotless Fixation Device: K06 1349 (cleared July 14, 2006) Description The MultiFIX P Knotless Fixation Device (MultiFIX P) is a bone anchor with inserter handle… | 2006 |
What descends from it? (11)
See all 112 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 20 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K131182 (Arthocare Corporation, 2013) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K061349.
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. 2012, 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 P Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: * Shoulder: Bankart Repair, SLAP lesion repair, acromnio-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 (97 words)
The MultiFiX P Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
* Shoulder: Bankart Repair, SLAP lesion repair, acromnio-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.
https://510kreport.com/device/K120096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120096: Multifix P Knotless Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120096
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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