510(k) · Cleared

Cleared

Panalok RC Loop Anchor

K041065510(k) SpecialCleared May 7, 200414-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy Mitek · JDR Staple, Fixation, Bone

Cleared on May 7, 2004 as substantially equivalent to K002639 (Mitek Products, 2001) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: May 7, 2004
Review: 14 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K964013 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK964013 Mitek Absorbable Toggle AnchorMitek Products · 1997
This deviceK041065 Panalok RC Loop AnchorDepuy Mitek · 2004
Descendant · cites it directly · 0 of its ownK060553 RC Loop /Dual Orthocord Suture,RC Loop W/Ethibond Suture,RC Loop…Depuy Mitek, A Johnson & Johnson Company · 2006

Most influential descendants

Showing 1 of 1 · See all

K060553RC Loop /Dual Orthocord Suture,RC Loop W/Ethibond Suture,RC Loop W/Panacryl SutureDepuy Mitek, A Johnson & Johnson Company · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964013	Mitek Absorbable Toggle Anchor	Mitek Products	1997	—
0 (this device)	K041065	Panalok RC Loop Anchor	Depuy Mitek	2004	—
+1	K060553	RC Loop /Dual Orthocord Suture,RC Loop W/Ethibond Suture,RC Loop W/Panacryl…	Depuy Mitek, A Johnson & Johnson Company	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K041065, 1997–2006Source: 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 JDR? 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 JDR device

#1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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? (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
*	K002639	Bioknotless Anchor Summary page 2 …RC Loop Anchor represents the same fundamental scientific technology as the existing S BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013); Mitek believes the Panalok RC…	Mitek Products	2001	2
*	K964013	Mitek Absorbable Toggle Anchor Summary page 2 …ental scientific technology as the existing S BioKnotless Anchor (K002639) and Panalok RC Anchor (K964013); Mitek believes the Panalok RC Loop Anchor is substantially equivalent to the BioKnotless An…	Mitek Products	1997	—

Also cleared against K002639: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060553	RC Loop /Dual Orthocord Suture,RC Loop W/Ethibond Suture,RC Loop W/Panacryl Suture	Depuy Mitek, A Johnson & Johnson Company	2006	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K060553 (Depuy Mitek, A Johnson & Johnson Company, 2006) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K002639.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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	8	70	0	3
2008	5	89	1	14
2009	0	—	0	10
2010	2	—	0	35
2011	1	—	0	62
2012	1	—	0	34
2013	9	137	0	27
2014	11	97	0	49
2015	7	111	1	48
2016	6	101	0	76
2017	9	172	0	116
2018	8	107	1	239
2019	5	149	0	242
2020	4	161	1	234
2021	3	62	0	210
2022	5	107	11	202
2023	9	72	0	175
2024	4	29	0	206
2025	3	65	0	314
2026	2	—	2	—

What is it indicated for?

The Mitek Panalok RC Loop Anchors are indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows:

Shoulder: Rotator cuff repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041065 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041065: Panalok RC Loop Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041065

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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