510(k) · Cleared
ClearedQuatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cayenne Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 31, 2012 as substantially equivalent to K112876 (Cayenne Medical, Inc., 2011) and 2 other predicates after a 91-day review. Its family tree reaches back 6 generations to 1996. 6 later devices descend from it.
- Decided
- Oct 31, 2012
- Review
- 91 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K961555 (1996). 17 ancestors in all, the oldest K915889 (1992). 6 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 3 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 2 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 1 generation backK093428 Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
- This deviceK122314 Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK182507 Tigon Medical Tissue AnchorsTigon Medical · 2019
- Descendant · 2 generations on · 1 of its ownK220464 Tigon Medical Gryphon Anchor LineTigon Medical · 2023
- Descendant · 2 generations on · 0 of its ownK260921 Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture…Tigon Medical · 2026
- Descendant · cites it directly · 0 of its ownK210498 Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd. · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK190915 OsteoFab Suture AnchorsOxford Performance Materials, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182507Tigon Medical Tissue AnchorsTigon Medical · 2019 · cites it directly2descendants
- K220464Tigon Medical Gryphon Anchor LineTigon Medical · 2023 · 2 generations on1descendant
- K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical · 2026 · 2 generations on0descendants
- K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd. · 2021 · cites it directly0descendants
- K190915OsteoFab Suture AnchorsOxford Performance Materials, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −5 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −4 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −3 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −2 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −1 | K093428 | Smith & Nephew Knotless Instability Anchor | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| 0 (this device) | K122314 | Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only | Cayenne Medical, Inc. | 2012 | — |
| +1 | K182507 | Tigon Medical Tissue Anchors | Tigon Medical | 2019 | — |
| +2 | K220464 | Tigon Medical Gryphon Anchor Line | Tigon Medical | 2023 | — |
| +2 | K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | 2026 | — |
| +1 | K210498 | Betta Link Knotless Implant System | T.A.G. Medical Products Corporation, Ltd. | 2021 | 1 |
| +1 | K190915 | OsteoFab Suture Anchors | Oxford Performance Materials, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K112876 | Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM)… | 2011 |
| * | K093897 | Smith & Nephew Footprint Ultra PK Suture AnchorSummary page 3…e substantially equivalent to preamendment devices: Cayenne Medical Quattro Link (CuffLink ) Knotless Anchor (KI 12876), Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) and Smith & Nephew Bioraptor Suture Anchor (K093428). The data included in this submission demonstrates substantial equivalence… | 2010 |
| * | K093428 | Smith & Nephew Knotless Instability AnchorSummary page 3…ayenne Medical Quattro Link (CuffLink ) Knotless Anchor (KI 12876), Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) and Smith & Nephew Bioraptor Suture Anchor (K093428). The data included in this submission demonstrates substantial equivalence to the predicate devices listed above. The subject… | 2009 |
What descends from it? (6)
4 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 16 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 17 ancestors have a recall of any class.
- Of its descendants, K182507 (Tigon Medical, 2019) has gone furthest, with 2 descendants of its own.
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 Cayenne Medical, Inc. QuattroTm Link Knotless Anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder - Capsular stabilization " Bankart repair o Anterior shoulder instability " SLAP lesion repairs o Capsular shift or capsulolabral reconstructions - Acromoclavicular separation repairs - Deltoid repairs - Rotator cuff repairs - Bicep tenodesis Elbow, Wrist, and Hand. - Biceps tendon reattachment…
Read the full statement (135 words)
The Cayenne Medical, Inc. QuattroTm Link Knotless Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
- Capsular stabilization
" Bankart repair
o Anterior shoulder instability
" SLAP lesion repairs
o Capsular shift or capsulolabral reconstructions
- Acromoclavicular separation repairs
- Deltoid repairs
- Rotator cuff repairs
- Bicep tenodesis
Elbow, Wrist, and Hand.
- Biceps tendon reattachment
- Ulnar or radial collateral ligament reconstruction
- Lateral epicondylitis repair
Knee
- Extra-capsular repairs
o Medial collateral ligament
o Lateral collateral ligament
o Posterior oblique ligament
- Patellar realignment and tendon repairs
o Vastus medials obliquous advancement
- Illiotibial band tenodesis
Foot and Ankle
- Hallux valgus repairs
- Medial or Lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- Midfoot reconstructions
- Metatarsal ligament/tendon repairs/reconstmuctions
- Bunionectomy
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122314: Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122314
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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