510(k) Report

510(k) · Cleared

Cleared

Inion Anchron Biodegradable Anchor System, Model Anc-6000

K051362510(k) TraditionalCleared Aug 4, 200571-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 Aug 4, 2005 as substantially equivalent to K970896 (ETHICON, Inc., 1997) after a 71-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided
Aug 4, 2005
Review
71 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K970896 (1997). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant clearedK970896 · Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System · ETHICON, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K970896 · Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System · ETHICON, Inc. · 19970
  1. Root · 1 generation backK970896 Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor SystemETHICON, Inc. · 1997
  2. This deviceK051362 Inion Anchron Biodegradable Anchor System, Model Anc-6000Inion OY · 2005
  3. Descendant · cites it directly · 0 of its ownK062782 Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001Inion OY · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K062782Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001Inion OY · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K970896Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor SystemETHICON, Inc.1997—
0 (this device)K051362Inion Anchron Biodegradable Anchor System, Model Anc-6000Inion OY2005—
+1K062782Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001Inion OY2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K051362, 1997–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K970896Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System
Summary page 1
…lass II Product Code: MAI PREDICATE DEVICE Modified Mitek 3.5 mm Panalok Wedge Absorbable Suture Anchor System (K970896) CONFORMANCE WITH PERFORMANCE STANDARDS No applicable mandatory performance standards exis…
ETHICON, Inc.1997—

Also cleared against K970896: 8 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K062782Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001Inion OY20060

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?

  • Its one ancestor has no recall.
  • Of its descendants, K062782 (Inion OY, 2006) has gone furthest, with 0 descendants of its own.
  • 8 other devices also cite its predicate K970896.

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

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
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

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

The INION ANCHRONTM 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 (151 words)

The INION ANCHRONTM 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.

Also cleared against K970896

8 other devices cite the same predicate.

  • K1208243.9MM Reelx STT Suture Anchor SystemStryker Corp. · 2012
  • K070347Allofix Push-in AnchorMusculoskeletal Transplant Foundation · 2007
  • K063273Panalok Quickanchor Plus, Panalok RC Quickanchor Plus Dual Suture, Panalok AnchorDepuy Miltek, A Johnson & Johnson Co. · 2006
  • K032072Lactosorb L15 Screw Anchor with Lactocarbonate SutureArthrotek, Inc. · 2003
  • K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
  • K023013Stryker Xcel Anchor SystemStryker Endoscopy · 2003

More from Inion OY

14 FDA decisions under this applicant name. See the company

  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025
  • K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OY · 2025
  • K203105Inion CompressOn ScrewInion OY · 2021
  • K191764Inion BioRestoreInion OY · 2019
  • K151360Inion Spinal Graft Containment SystemInion OY · 2015

Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K051362 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051362: Inion Anchron Biodegradable Anchor System, Model Anc-6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051362

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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