510(k) Report

510(k) · Cleared

Cleared

Axya Medical, Inc. Model 1000 Axyaloop Bone Anchor

K003971510(k) TraditionalCleared Mar 21, 200189-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

Axya Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Mar 21, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Mar 21, 2001
Review
89 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2013: 2 descendants cleared2011: 1 descendant cleared2015: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK003971 Axya Medical, Inc. Model 1000 Axyaloop Bone AnchorAxya Medical, Inc. · 2001
  2. Descendant · cites it directly · 7 of its ownK083268 Tornier, Inc., Insite Suture AnchorsTornier, Inc. · 2009
  3. Descendant · 2 generations on · 5 of its ownK110773 Tornier Insite FT Suture AnchorTornier, Inc. · 2011
  4. Descendant · 3 generations on · 2 of its ownK150715 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015
  5. Descendant · 3 generations on · 1 of its ownK201636 Hercules Suture Anchor SystemIn2bones USA, LLC · 2020
  6. Descendant · 4 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12013: 22014: 12015: 12020: 12026: 1
2009high 2 (2013) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all
  • K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc. · 2009 · cites it directly7descendants
  • K110773Tornier Insite FT Suture AnchorTornier, Inc. · 2011 · 2 generations on5descendants
  • K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc. · 2015 · 3 generations on2descendants
  • K201636Hercules Suture Anchor SystemIn2bones USA, LLC · 2020 · 3 generations on1descendant
  • K253538TeKBrace Knotless AnchorTheramicro · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003971Axya Medical, Inc. Model 1000 Axyaloop Bone AnchorAxya Medical, Inc.2001—
+1K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.2009—
+2K110773Tornier Insite FT Suture AnchorTornier, Inc.2011—
+3K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.2015—
+3K201636Hercules Suture Anchor SystemIn2bones USA, LLC2020—
+4K253538TeKBrace Knotless AnchorTheramicro2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201320
201410
201510
202010
202610
FIG. 1 — Lineage of K003971, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MBI? 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 MBI device

  1. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc.20097

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?

  • Of its descendants, K083268 (Tornier, Inc., 2009) has gone furthest, with 7 descendants of its own.

How does its category compare?

All MBI devices

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

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

More from Axya Medical, Inc.

19 FDA decisions under this applicant name. See the company

  • K070773Axya, Model 3000 Axyzloop Titanium Bone AnchorAxya Medical, Inc. · 2007
  • K070253Axya Suture Welding System and KitAxya Medical, Inc. · 2007
  • K063194Tufflex Polyester SutureAxya Medical, Inc. · 2006
  • K060165Axyaflex Polyester SutureAxya Medical, Inc. · 2006
  • K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 200621 recalls

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K003971 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003971: Axya Medical, Inc. Model 1000 Axyaloop Bone Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003971

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026