510(k) · Cleared

Cleared

Quattro GL Suture Anchor

K131325510(k) TraditionalCleared Aug 16, 2013100-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

Cayenne Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Aug 16, 2013 as substantially equivalent to K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) and 5 other predicates after a 100-day review. Its family tree reaches back 6 generations to 1999.

Decided: Aug 16, 2013
Review: 100 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 6

Its longest line of descent runs back 6 generations to K990088 (1999). 26 ancestors in all, the oldest K930738 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
5 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
4 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
3 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
2 generations backK070673 Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007
1 generation backK112960 Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1)…Cayenne Medical, Inc. · 2012
This deviceK131325 Quattro GL Suture AnchorCayenne Medical, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K990088	Synthofil Nonabsorbable Pet Surgical Suture	Aesculap, Inc.	1999	—
−5	K012923	Arthrex Fiberwire, Usp Size 5, Model AR-7201	Arthrex, Inc.	2001	—
−4	K021434	Arthrex Fiberwire in Usp Sizes	Arthrex, Inc.	2002	—
−3	K063778	Force Fiber Polyethylene Nonabsorbable Suture	Teleflex Medical	2007	1
−2	K070673	Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture	Teleflexmedical, Inc.	2007	—
−1	K112960	Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2)…	Cayenne Medical, Inc.	2012	—
0 (this device)	K131325	Quattro GL Suture Anchor	Cayenne Medical, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1996	2	0
1998	1	0
2000	3	0
2001	3	0
2003	1	0
2004	2	0
2005	1	0
2006	2	0
2007	2	0
2009	1	0
2010	1	0

FIG. 1 — Lineage of K131325, 1999–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K071586	Bioraptor 2.3 PK Suture Anchor Summary page 3 …les to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor (K071586), Quattro® GL (LabraLink) Suture Anchor (Ki 12960), Force Fiber Blue Co-Braid Polyethylene non-absorbable surgical suture (K04047…	Smith & Nephew Inc., Endoscopy Division	2007	1
*	K112960	Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe… Summary page 3 …echnology, materials, manufacturing processes, packaging, sterilization method, and shelf life as the Cayenne Medical Quattro GL (LabraLink) Suture Anchor with Inserter (K1 12960) and the expansion of indications for use does not introduce new issues of safety and effectiveness.…	Cayenne Medical, Inc.	2012	—
*	K040472	Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture Summary page 3 …Nephew BIORAPTOR 2.3 PK Suture Anchor (K071586), Quattro® GL (LabraLink) Suture Anchor (Ki 12960), Force Fiber Blue Co-Braid Polyethylene non-absorbable surgical suture (K040472), Force Fiber Black Co-Braid Polyethylene non-absorbable surgical suture (K070673), Force Fiber Green Co-Braid Polyethylene non-a…	Teleflex Medical	2004	—
*	K070673	Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture Summary page 3 …chor (Ki 12960), Force Fiber Blue Co-Braid Polyethylene non-absorbable surgical suture (K040472), Force Fiber Black Co-Braid Polyethylene non-absorbable surgical suture (K070673), Force Fiber Green Co-Braid Polyethylene non-absorbable surgical suture (K100506), and Force Fiber Blue Polyethylene non-absorba…	Teleflexmedical, Inc.	2007	—
*	K100506	Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures… Summary page 3 …ture (K040472), Force Fiber Black Co-Braid Polyethylene non-absorbable surgical suture (K070673), Force Fiber Green Co-Braid Polyethylene non-absorbable surgical suture (K100506), and Force Fiber Blue Polyethylene non-absorbable surgical suture (K092533). The substantial equivalence of Quattro GL Suture An…	Teleflex Medical	2010	—
*	K092533	Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Summary page 3 …cal suture (K070673), Force Fiber Green Co-Braid Polyethylene non-absorbable surgical suture (K100506), and Force Fiber Blue Polyethylene non-absorbable surgical suture (K092533). The substantial equivalence of Quattro GL Suture Anchor is based on similarities in indications for use, design features, techn…	Beere Precision Medical Instruments, Kmedic, Telef	2009	—

Also cleared against K071586: 22 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 14 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
9 of the 26 ancestors have a recall of any class.
22 other devices also cite its predicate K071586.

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. 2013, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

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

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

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. Quattroo GL Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Hip - Hip capsule repair o Acetabular labrum reattachment Shoulder - Capsular stabilization o Bankart repair o Anterior shoulder instability o SLAP lesion repairs o Capsular shift or capsulolabral reconstructions - Acromnioclavicular separation repairs - Deltoid repairs - Rotator cuff repairs - Biceps tenodesis Elbow…

Read the full statement (141 words)

The Cayenne Medical, Inc. Quattroo GL Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Hip

- Hip capsule repair

o Acetabular labrum reattachment

Shoulder

- Capsular stabilization

o Bankart repair

o Anterior shoulder instability

o SLAP lesion repairs

o Capsular shift or capsulolabral reconstructions

- Acromnioclavicular separation repairs

- Deltoid repairs

- Rotator cuff repairs

- Biceps 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

Posterior oblique ligament

- Patellar realignment and tendon repairs

o Vastus medials obliquous advancement

- illiotibial band tenodesis

Foot and Ankle

- H-aliux valgus repairs

- Medial or Lateral instability repairs/reconstructions

- Achilles tendon repairs/reconstructions

- Midifoot reconstructions

- Metatarsal ligament/tendlon rcpairs/reconstructions

- Bunionectomy

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131325 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131325: Quattro GL Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131325

Report an extraction error

Are you the manufacturer?

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