510(k) · Cleared

Cleared

4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,

K142574510(k) SpecialCleared Oct 24, 201442-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

Depuy Mitek, A Johnson & Johnson Company · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Oct 24, 2014 as substantially equivalent to K082282 (Depuy Mitek, A Johnson & Johnson Co., 2008) after a 42-day review. Its family tree reaches back 4 generations to 2001.

Decided: Oct 24, 2014
Review: 42 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K010673 (2001). 17 ancestors in all, the oldest K930893 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK010673 Arthrex Fiberwire, Model Spu-02NB-3800Arthrex, Inc. · 2001
3 generations backK040004 Orthocord SutureDepuy Mitek · 2004 · Recalled
2 generations backK043298 Blue Orthocord SutureDepuy Mitek · 2004 · Recalled
1 generation backK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
This deviceK142574 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture…Depuy Mitek, A Johnson & Johnson Company · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K010673	Arthrex Fiberwire, Model Spu-02NB-3800	Arthrex, Inc.	2001	—
−3	K040004	Orthocord Suture	Depuy Mitek	2004	1
−2	K043298	Blue Orthocord Suture	Depuy Mitek	2004	6
−1	K082282	Healix TI Anchor	Depuy Mitek, A Johnson & Johnson Co.	2008	—
0 (this device)	K142574	4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm…	Depuy Mitek, A Johnson & Johnson Company	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
1998	1	0
2001	2	0
2002	1	0
2004	3	0
2005	1	0
2006	2	0
2007	1	0

FIG. 1 — Lineage of K142574, 2001–2014Source: 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? (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	Applicant	Decided	Recalls
*	K082282	Healix TI Anchor Summary page 5 …Common Name: Suture Anchor Substantial The Healix Ti™ Anchor with Permacord™ is substantially equivalent to: Equivalence  K082282 Healix Ti™ Anchor with Orthocord® Reference Devices:  K133794 Healix Advance™ Anchor with…	Depuy Mitek, A Johnson & Johnson Co.	2008	—
†	K133794	4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…	Depuy Mitek, A Johnson & Johnson Company	2014	—
†	K140324	Rigidloop Adjustable Cortical Implant: Standard, Long and XL	Depuy Mitek, A Johnson and Johnson Company	2014	—

Also cleared against K082282: 3 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 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
5 of the 17 ancestors have a recall of any class.
3 other devices also cite its predicate K082282.

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. 2014, 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 Healix Ti Anchor is intended for: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon…

Read the full statement (78 words)

The Healix Ti Anchor is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair,

Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial

Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular Repair, Acetabular Labral Repair

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142574 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142574: 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142574

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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