510(k) · Cleared

Cleared

Healix Anchor

K071481510(k) TraditionalCleared Aug 9, 200772-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 · HWC Screw, Fixation, Bone

Cleared on Aug 9, 2007 as substantially equivalent to K041069 (Depuy Mitek, A Johnson & Johnson Company, 2004) and 1 other predicate after a 72-day review. Its family tree reaches back 2 generations to 2002. 99 later devices descend from it.

Decided: Aug 9, 2007
Review: 72 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K021883 (2002). 4 ancestors in all, the oldest K003227 (2001). 99 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 2 generations backK021883 Biofastin RC Threaded Suture AnchorMitek Worldwide · 2002
1 generation backK041069 Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
This deviceK071481 Healix AnchorDepuy Mitek, A Johnson & Johnson Company · 2007
Descendant · cites it directly · 50 of its ownK120449 Healix Advance Peek AnchorDepuy Mitek · 2012
Descendant · cites it directly · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
Descendant · 2 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
Descendant · 2 generations on · 25 of its ownK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
Descendant · 2 generations on · 24 of its ownK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2008high 9 (2011) · low 1 (2009)2026

Most influential descendants

Showing 5 of 99 · See all

K120449Healix Advance Peek AnchorDepuy Mitek · 2012 · cites it directly50descendants
K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · cites it directly44descendants
K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 2 generations on31descendants
K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company · 2009 · 2 generations on25descendants
K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company · 2010 · 2 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K021883	Biofastin RC Threaded Suture Anchor	Mitek Worldwide	2002	—
−1	K041069	Spiralok Anchor	Depuy Mitek, A Johnson & Johnson Company	2004	16
0 (this device)	K071481	Healix Anchor	Depuy Mitek, A Johnson & Johnson Company	2007	—
+1	K120449	Healix Advance Peek Anchor	Depuy Mitek	2012	—
+1	K073412	Gryphon BR and Healix BR Anchors	Depuy Mitek, A Johnson & Johnson Company	2008	1
+2	K133636	Extremity Medical Hammertoe Device	Extremity Medical, LLC	2014	—
+2	K090124	Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model…	Depuy Mitek, A Johnson & Johnson Company	2009	2
+2	K100012	Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon…	Depuy Mitek, A Johnson & Johnson Company	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2009	1	0
2010	1	0
2011	9	0
2012	3	0
2013	6	0
2014	8	0
2015	6	0
2016	2	0
2017	4	0
2018	5	0
2019	9	0
2020	7	0
2021	8	0
2022	2	0
2023	9	0
2024	7	0
2025	4	0
2026	6	0

FIG. 1 — Lineage of K071481, 2002–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K041069	Spiralok Anchor Summary page 1 …tary Name: Healix Anchor Substantial Equivalence Healix Anchor is substantially equivalent to: Mitek Spiralok Anchor (K041069 and K060271). The Healix Anchor is also similar to the Arthrex Corkscrew FT Anchor (K061863 and…	Depuy Mitek, A Johnson & Johnson Company	2004	16
*	K060271	Spiralok Anchor Summary page 1 …Healix Anchor Substantial Equivalence Healix Anchor is substantially equivalent to: Mitek Spiralok Anchor (K041069 and K060271). The Healix Anchor is also similar to the Arthrex Corkscrew FT Anchor (K061863 and…	Depuy Mitek, A Johnson & Johnson Company	2006	16

What descends from it? (99)

See all 99

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

Number	Device	Applicant	Decided	Descendants
K120449	Healix Advance Peek Anchor	Depuy Mitek	2012	50
K073412	Gryphon BR and Healix BR Anchors	Depuy Mitek, A Johnson & Johnson Company	2008	44
K082282	Healix TI Anchor	Depuy Mitek, A Johnson & Johnson Co.	2008	21
K102298	Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…	Depuy Mitek, A Johnson & Johnson Company	2011	15
K110229	Rog Suture Anchor 5.5MM, 2.9MM	Rog Sports Medicine, Inc.	2011	6
K103712	Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord	Depuy Mitek, A Johnson & Johnson Company	2011	6

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 5 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
2 of the 4 ancestors have a recall of any class.
Of its descendants, K120449 (Depuy Mitek, 2012) has gone furthest, with 50 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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;

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/K071481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071481: Healix Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071481

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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