510(k) · Cleared
ClearedFix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonic Co., Ltd. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Dec 3, 2024 as substantially equivalent to K202806 (Osteonic Co., Ltd., 2021) and 1 other predicate after a 25-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- Dec 3, 2024
- Review
- 25 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K961555 (1996). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations between
- 3 generations backK192032 Fixone Biocomposite Small AnchorAju Pharm Co., Ltd. · 2020
- 2 generations backK202806 Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self…Osteonic Co., Ltd. · 2021
- 1 generation backK231326 Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd. · 2023
- This deviceK243467 Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self…Osteonic Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 10 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 9 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 8 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 7 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 6 generations backK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- 5 generations backK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
- 4 generations backK140855 Arthrex Suturetak Suture AnchorsArthrex, Inc. · 2014
- 3 generations backK192032 Fixone Biocomposite Small AnchorAju Pharm Co., Ltd. · 2020
- 2 generations backK202806 Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self…Osteonic Co., Ltd. · 2021
- 1 generation backK231326 Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd. · 2023
- This deviceK243467 Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self…Osteonic Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −10 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −9 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −8 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −7 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −6 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| −5 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
| −4 | K140855 | Arthrex Suturetak Suture Anchors | Arthrex, Inc. | 2014 | — |
| −3 | K192032 | Fixone Biocomposite Small Anchor | Aju Pharm Co., Ltd. | 2020 | — |
| −2 | K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | 2021 | — |
| −1 | K231326 | Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | 2023 | — |
| 0 (this device) | K243467 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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? (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 | Decided |
|---|---|---|---|
| * | K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Summary page 5…Subsequent Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3030 Device Class: II 04. Predicate device 510(k) Number: K202806, K231326 Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Manufacturer:… | 2021 |
| * | K231326 | Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Summary page 5…equent Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3030 Device Class: II 04. Predicate device 510(k) Number: K202806, K231326 Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Manufacturer: Osteonic… | 2023 |
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 28 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K202806.
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. 2024, 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 Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow. 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, Metatarsal Ligament Repair…
Read the full statement (124 words)
The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure;
shoulder, foot/ankle, knee, hand/wrist and elbow.
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, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
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/K243467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243467: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243467
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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