510(k) · Cleared
ClearedVarious
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 13, 2012 as substantially equivalent to K915889 (Mitek Surgical Products, Inc., 1992) and 1 other predicate after a 143-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jan 13, 2012
- Review
- 143 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010673 (2001). 23 ancestors in all, the oldest K915889 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK010673 Arthrex Fiberwire, Model Spu-02NB-3800Arthrex, Inc. · 2001
- 4 generations backK040004 Orthocord SutureDepuy Mitek · 2004 · Recalled
- 3 generations backK043298 Blue Orthocord SutureDepuy Mitek · 2004 · Recalled
- 2 generations backK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
- 1 generation backK111631 Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture…Depuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK112417 VariousDepuy Mitek, A Johnson & Johnson Company · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010673 | Arthrex Fiberwire, Model Spu-02NB-3800 | Arthrex, Inc. | 2001 | — |
| −4 | K040004 | Orthocord Suture | Depuy Mitek | 2004 | 1 |
| −3 | K043298 | Blue Orthocord Suture | Depuy Mitek | 2004 | 6 |
| −2 | K082282 | Healix TI Anchor | Depuy Mitek, A Johnson & Johnson Co. | 2008 | — |
| −1 | K111631 | Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| 0 (this device) | K112417 | Various | Depuy Mitek, A Johnson & Johnson Company | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K915889 | Mitek Bone Anchor, ModificationSummary page 1…turing processes. The only proposition of this 510(k) submission is to add a generic "MR- Conditional" statement and symbol to the product package insert and labels.. * K915889 -GII'"Anchor *K111631 Metal Implants -Various DEVICE CLASSIFICATION * GILT ' Anchor - K91… | 1992 |
| * | K111631 | Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…Summary page 1…nly proposition of this 510(k) submission is to add a generic "MR- Conditional" statement and symbol to the product package insert and labels.. * K915889 -GII'"Anchor *K111631 Metal Implants -Various DEVICE CLASSIFICATION * GILT ' Anchor - K915889 o Device… | 2011 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 23 ancestors have a recall of any class.
- 5 other devices also cite its predicate K915889.
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?
SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsulolabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair. ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Medial instability; Midfoot reconstructions. FOOT: Hallux valgus reconstruction. WRIST: Scapholunate ligament reconstruction. HAND: Ulnar or lateral collateral ligament reconstruction. ELBOW: Biceps tendon reattachment; Tennis…
Read the full statement (112 words)
SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsulolabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair.
ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Medial instability; Midfoot reconstructions.
FOOT: Hallux valgus reconstruction.
WRIST: Scapholunate ligament reconstruction.
HAND: Ulnar or lateral collateral ligament reconstruction.
ELBOW: Biceps tendon reattachment; Tennis elbow repair.
KNEE: Extra capsular reconstruction, ITB tenodesis; Lateral collateral ligament; Patellar ligament and tendon avulsion repairs; Posterior oblique ligament or joint capsule to tibia; Joint capsule closure to anterior proximal tibia; Medial collateral ligament.
BNS: Fixation in pubic bone for bladder neck suspension using USP #2 Class I nonabsorbable synthetic suture (e.g. polypropylene). A minimum of 2 Anchors should be used in this procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112417: Various.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112417
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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