510(k) · Cleared
ClearedFixone Biocomposite Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aju Pharm Co., Ltd. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Mar 11, 2020 as substantially equivalent to K171299 (Aju Pharm Co., Ltd., 2017) after a 183-day review. Its family tree reaches back 8 generations to 1997. 3 later devices descend from it.
- Decided
- Mar 11, 2020
- Review
- 183 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K971358 (1997). 31 ancestors in all, the oldest K961555 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 7 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 6 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 5 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 4 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 3 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 2 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 1 generation backK171299 Fixone Biocomposite AnchorAju Pharm Co., Ltd. · 2017
- This deviceK192484 Fixone Biocomposite AnchorAju Pharm Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK203523 Fixone hybrid knotless anchorAju Pharm Co., Ltd. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK230892 Fixone Biocomposite AnchorAju Pharm Co., Ltd. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK212912 OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors…B-One Ortho, Corp. · 2021
Most influential descendants
Showing 3 of 3 · See all- K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd. · 2021 · cites it directly1descendant
- K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd. · 2023 · 2 generations on0descendants
- K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −7 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −6 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −5 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −4 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −3 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −2 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −1 | K171299 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2017 | — |
| 0 (this device) | K192484 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2020 | — |
| +1 | K203523 | Fixone hybrid knotless anchor | Aju Pharm Co., Ltd. | 2021 | 8 |
| +2 | K230892 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | 2023 | 8 |
| +1 | K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All… | B-One Ortho, Corp. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K171299 | Fixone Biocomposite AnchorSummary page 4…son address : 300, Atwood Street, Pittsburgh, PA, 15213, USA 8) Submission date : Mar. 11, 2020 9) Submission type : Traditional 10) Prior related submissions : K171299 2. Device Information 1) Trade name : Fixone Biocomposite Anchor 2) Common name : Biodegradable Orthopedic Bone Screw… | 2017 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 9 of the 31 ancestors have a recall of any class.
- Of its descendants, K203523 (Aju Pharm Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 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 Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee
and elbow in the following procedures:
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, lliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
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/K192484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192484: Fixone Biocomposite Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192484
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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