510(k) · Cleared

Cleared

Healix TI Anchor

K082282510(k) TraditionalCleared Nov 7, 200888-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 Co. · HWC Screw, Fixation, Bone

Cleared on Nov 7, 2008 as substantially equivalent to K071481 (Depuy Mitek, A Johnson & Johnson Company, 2007) and 5 other predicates after an 88-day review. Its family tree reaches back 3 generations to 2001. 21 later devices descend from it.

Decided: Nov 7, 2008
Review: 88 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 6

Its longest line of descent runs back 3 generations to K010673 (2001). 16 ancestors in all, the oldest K930893 (1993). 21 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK010673 Arthrex Fiberwire, Model Spu-02NB-3800Arthrex, Inc. · 2001
2 generations backK040004 Orthocord SutureDepuy Mitek · 2004 · Recalled
1 generation backK043298 Blue Orthocord SutureDepuy Mitek · 2004 · Recalled
This deviceK082282 Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
Descendant · cites it directly · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
Descendant · 2 generations on · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
Descendant · 2 generations on · 6 of its ownK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
Descendant · 3 generations on · 3 of its ownK222091 Grappler Suture Anchor SystemParagon 28, Inc. · 2022
Descendant · 3 generations on · 2 of its ownK223589 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2011high 4 (2011) · low 0 (2015)2026

Most influential descendants

Showing 5 of 21 · See all

K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly15descendants
K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · 2 generations on6descendants
K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011 · 2 generations on6descendants
K222091Grappler Suture Anchor SystemParagon 28, Inc. · 2022 · 3 generations on3descendants
K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K010673	Arthrex Fiberwire, Model Spu-02NB-3800	Arthrex, Inc.	2001	—
−2	K040004	Orthocord Suture	Depuy Mitek	2004	1
−1	K043298	Blue Orthocord Suture	Depuy Mitek	2004	6
0 (this device)	K082282	Healix TI Anchor	Depuy Mitek, A Johnson & Johnson Co.	2008	—
+1	K102298	Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend…	Depuy Mitek, A Johnson & Johnson Company	2011	—
+2	K211002	Grappler Suture Anchor System	Paragon 28, Inc.	2021	1
+2	K103712	Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord	Depuy Mitek, A Johnson & Johnson Company	2011	—
+3	K222091	Grappler Suture Anchor System	Paragon 28, Inc.	2022	—
+3	K223589	Grappler Suture Anchor R3FLEX IOL System	Paragon 28, Inc.	2023	—

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	4	0
2012	1	0
2013	2	0
2014	3	0
2018	1	0
2019	1	0
2021	2	0
2022	1	0
2023	2	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K082282, 2001–2026Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K071481	Healix Anchor Summary page 1 …y Name: Healix Ti Anchor Substantial Equivalence Healix Ti Anchor is substantially equivalent to: Mitek Healix Anchor K071481 (Aug 9, 2007) Fastin RC Anchor K060664,K0041075 (June 6, 2006; Nov 9, 2004).…	Depuy Mitek, A Johnson & Johnson Company	2007	—
*	K060664	Fastin RC Anchor Summary page 1 …x Ti Anchor is substantially equivalent to: Mitek Healix Anchor K071481 (Aug 9, 2007) Fastin RC Anchor K060664,K0041075 (June 6, 2006; Nov 9, 2004). Super QA+ Anchor K052631 (Oct 21, 2005)…	Depuy Mitek	2006	—
*	K041075	Fastin RC Anchor Summary page 1 …r is substantially equivalent to: Mitek Healix Anchor K071481 (Aug 9, 2007) Fastin RC Anchor K060664,K0041075 (June 6, 2006; Nov 9, 2004). Super QA+ Anchor K052631 (Oct 21, 2005)…	Depuy Mitek, A Johnson & Johnson Company	2004	1
*	K052631	Super Quickanchor Plus (with Orthocord Suture) Summary page 1 …r K071481 (Aug 9, 2007) Fastin RC Anchor K060664,K0041075 (June 6, 2006; Nov 9, 2004). Super QA+ Anchor K052631 (Oct 21, 2005) Orthocord, violet (size #2) suture, K040004 (April 13, 2004)…	Depuy Mitek, A Johnson & Johnson Company	2005	—
*	K040004	Orthocord Suture Summary page 1 …June 6, 2006; Nov 9, 2004). Super QA+ Anchor K052631 (Oct 21, 2005) Orthocord, violet (size #2) suture, K040004 (April 13, 2004) Orthocord blue (size #2) suture, K043298 (Dec 10, 2004).…	Depuy Mitek	2004	1
*	K043298	Blue Orthocord Suture Summary page 1 …21, 2005) Orthocord, violet (size #2) suture, K040004 (April 13, 2004) Orthocord blue (size #2) suture, K043298 (Dec 10, 2004). The Healix Ti Anchor is also similar to the Arthrex Corkscrew FT…	Depuy Mitek	2004	6

Also cleared against K071481: 5 other devices →

What descends from it? (21)

See all 21

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102298	Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…	Depuy Mitek, A Johnson & Johnson Company	2011	15
K183279	HEALIX Ti ANCHOR with DYNACORD	Medos International SARL	2019	1
K111631	Gil Anchor / Gil Quick Anchor Plus, Healix TI Dual Threaded Suture Anchor, Rotator Cuff…	Depuy Mitek, A Johnson & Johnson Company	2011	1
K142574	4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti…	Depuy Mitek, A Johnson & Johnson Company	2014	0

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 7 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
5 of the 16 ancestors have a recall of any class.
Of its descendants, K102298 (Depuy Mitek, A Johnson & Johnson Company, 2011) has gone furthest, with 15 descendants of its own.
5 other devices also cite its predicate K071481.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

Healix Anchor is indicated for use in the following:

Shoulder: Rotor 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,

Patella tendon repair and secondary fixation in ACL / PCL reconstruction

Elbow: Biceps Tendon Reattachment, Uinar or Radial Collateral Ligament Reconstruction.

Hip: Capsular repair, acetabular labral repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082282 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082282: Healix TI Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082282

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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