510(k) · Cleared

Cleared

Healix Advance Peek Anchor

K120449510(k) TraditionalCleared May 11, 201287-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 · HWC Screw, Fixation, Bone

Cleared on May 11, 2012 as substantially equivalent to K071481 (Depuy Mitek, A Johnson & Johnson Company, 2007) after an 87-day review. Its family tree reaches back 3 generations to 2002. 50 later devices descend from it.

Decided: May 11, 2012
Review: 87 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K021883 (2002). 5 ancestors in all, the oldest K003227 (2001). 50 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK021883 Biofastin RC Threaded Suture AnchorMitek Worldwide · 2002
2 generations backK041069 Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
1 generation backK071481 Healix AnchorDepuy Mitek, A Johnson & Johnson Company · 2007
This deviceK120449 Healix Advance Peek AnchorDepuy Mitek · 2012
Descendant · cites it directly · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
Descendant · 2 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
Descendant · 3 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
Descendant · 4 generations on · 14 of its ownK181872 MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019
Descendant · cites it directly · 8 of its ownK133794 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2014high 6 (2014) · low 1 (2022)2026

Most influential descendants

Showing 5 of 50 · See all

K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · cites it directly31descendants
K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on16descendants
K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 3 generations on15descendants
K181872MIS Bunion SystemCrossroads Extremity Systems, LLC · 2019 · 4 generations on14descendants
K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company · 2014 · cites it directly8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K021883	Biofastin RC Threaded Suture Anchor	Mitek Worldwide	2002	—
−2	K041069	Spiralok Anchor	Depuy Mitek, A Johnson & Johnson Company	2004	16
−1	K071481	Healix Anchor	Depuy Mitek, A Johnson & Johnson Company	2007	—
0 (this device)	K120449	Healix Advance Peek Anchor	Depuy Mitek	2012	—
+1	K133636	Extremity Medical Hammertoe Device	Extremity Medical, LLC	2014	—
+2	K141857	CrossTie Intraosseous Fixation System	Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem	2015	—
+3	K151270	CrossTIE Intraosseous Fixation System	Crossroads Extremity Systems, LLC	2015	—
+4	K181872	MIS Bunion System	Crossroads Extremity Systems, LLC	2019	—
+1	K133794	4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture…	Depuy Mitek, A Johnson & Johnson Company	2014	—

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
2014	6	0
2015	6	0
2016	2	0
2017	2	0
2018	3	0
2019	6	0
2020	5	0
2021	4	0
2022	1	0
2023	4	0
2024	4	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K120449, 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

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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
*	K071481	Healix Anchor Summary page 1 …or threaded metallic bone fixation fasteners ! Common Name: Bone Anchor ' Substantial :I'he HEALIX ADVANCE PEEK Anchor is substantially equivalent to: . Equivalence » KO071481: Healix PEEK Anchor Facility Device Smooth or threaded metallic bone fixation fasteners, classified as Class II, product Classif…	Depuy Mitek, A Johnson & Johnson Company	2007	—

Also cleared against K071481: 5 other devices →

What descends from it? (50)

See all 50

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

Number	Device	Applicant	Decided	Descendants
K133636	Extremity Medical Hammertoe Device	Extremity Medical, LLC	2014	31
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	8
K133036	Apollo Suture Anchor System and Titan Screws	Amendia, Inc.	2014	7
K213110	AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor	Auxein Medical Private Limited	2022	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 10 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K133636 (Extremity Medical, LLC, 2014) has gone furthest, with 31 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. 2012, 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?

The HEALIX ADVANCE™ PEEK Anchor is indicated 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;

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

Hip: Capsular repair, Acetabular Labral Repair.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K120449 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120449: Healix Advance Peek Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120449

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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