510(k) · Cleared

Cleared

Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001

K062782510(k) SpecialCleared Nov 9, 200652-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

Inion OY · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Nov 9, 2006 as substantially equivalent to K051362 (Inion OY, 2005) after a 52-day review. Its family tree reaches back 2 generations to 1997.

Decided: Nov 9, 2006
Review: 52 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K970896 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK970896 Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor SystemETHICON, Inc. · 1997
1 generation backK051362 Inion Anchron Biodegradable Anchor System, Model Anc-6000Inion OY · 2005
This deviceK062782 Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001Inion OY · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970896	Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System	ETHICON, Inc.	1997	—
−1	K051362	Inion Anchron Biodegradable Anchor System, Model Anc-6000	Inion OY	2005	—
0 (this device)	K062782	Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001	Inion OY	2006	—

FIG. 1 — Lineage of K062782, 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 MAI? 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 MAI device

#1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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
*	K051362	Inion Anchron Biodegradable Anchor System, Model Anc-6000 Summary page 3 …M Plus Biodegradable Anchor System are substantially equivalent with the predicate device Inion Anchron TM Biodegradable Anchor System (K051362). Inion Anchron Tm Plus Biodegradable Anchor System is substantially equivalent to predicate C…	Inion OY	2005	—

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 9 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2007high 40 (2020) · low 0 (2007)2026

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

Adverse event reports per year · MAI

2,148in 2025

2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, 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	4	100	0	272
2008	3	83	0	172
2009	9	74	0	88
2010	4	122	0	89
2011	9	90	5	129
2012	6	56	10	171
2013	6	135	0	166
2014	4	86	0	149
2015	5	95	0	182
2016	3	191	0	301
2017	9	113	0	478
2018	13	108	0	1,590
2019	9	41	2	1,248
2020	9	78	40	957
2021	8	115	0	1,267
2022	6	136	0	1,425
2023	8	34	0	1,718
2024	7	53	0	2,300
2025	8	54	0	2,148
2026	5	69	1	—

What is it indicated for?

The INION ANCHRONT M PLUS BIODEGRADABLE ANCHOR SYSTEM is indicated for use in soft tissue to bone fixation in conjunction with appropriate post-operative immobilization as follows: A. Open procedures: 1. Shoulder: Bankart repair; SLAP lesion repair; Rotator cuff repair; Capsule shift/capsulo-labral reconstruction at the anterior glenoid rim site; Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus; Biceps tenodesis…

Read the full statement (137 words)

The INION ANCHRONT M PLUS BIODEGRADABLE ANCHOR SYSTEM is indicated for use in soft tissue to bone fixation in conjunction with appropriate post-operative immobilization as follows:

A. Open procedures:

1. Shoulder: Bankart repair; SLAP lesion repair; Rotator cuff repair; Capsule shift/capsulo-labral reconstruction at the anterior glenoid rim site; Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus; Biceps tenodesis; Acromio-clavicular separation

2. Elbow: Biceps tendon reattachment

3. Ankle: Achilles tendon repair/reconstruction; Lateral stabilization; Medial stabilization at the medial talus site

4. Knee: Medial collateral ligament repair; Lateral collateral ligament repair; Joint capsule closure to anterior proximal tibia; Posterior oblique ligament or joint capsule to tibia repair; Extra capsular reconstruction / ITB tenodesis; Patellar ligament and tendon avulsion repairs

B. Arthroscopic procedures:

1. Shoulder: Bankart repair; SLAP lesion repair; Rotator cuff repair; Capsule shift repair (glenoid rim)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062782 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062782: Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062782

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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