510(k) · Cleared
ClearedOSSIOfiber® Suture Anchor 2.5-3.5 mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OSSIO, Ltd. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Apr 3, 2025 as substantially equivalent to K180594 (Arthrex, Inc., 2018) and 1 other predicate after a 118-day review. Its family tree reaches back 13 generations to 1979.
- Decided
- Apr 3, 2025
- Review
- 118 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K792022 (1979). 108 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations between
- 3 generations backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- 2 generations backK193503 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2020
- 1 generation backK213415 OSSIOfiber Suture AnchorOSSIO, Ltd. · 2022
- This deviceK243760 OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd. · 2025
Show all 13 generations
- Root · 13 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 12 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 11 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 10 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 9 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 8 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 7 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 6 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 5 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 4 generations backK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- 3 generations backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- 2 generations backK193503 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2020
- 1 generation backK213415 OSSIOfiber Suture AnchorOSSIO, Ltd. · 2022
- This deviceK243760 OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −12 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −11 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −10 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −9 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −8 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −7 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| −6 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| −5 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| −4 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| −3 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
| −2 | K193503 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2020 | — |
| −1 | K213415 | OSSIOfiber Suture Anchor | OSSIO, Ltd. | 2022 | — |
| 0 (this device) | K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | OSSIO, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K180594 | Knotless SutureTak AnchorsSummary page 5…bone fixation appliances and accessories Regulatory Class: Class II, 21 C.F.R. § 888.3030 Product Code: MAI Primary Predicate: Knotless SutureTak Anchors (K180594) Additional Predicate: OSSIOfiber® Suture Anchor (K213415) Reference Devices: OSSIOfiber® Pin Product Family… | 2018 |
| * | K213415 | OSSIOfiber Suture AnchorSummary page 5…I, 21 C.F.R. § 888.3030 Product Code: MAI Primary Predicate: Knotless SutureTak Anchors (K180594) Additional Predicate: OSSIOfiber® Suture Anchor (K213415) Reference Devices: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSS… | 2022 |
| † | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable… | 2023 |
| † | K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | 2024 |
| † | K241932 | OSSIOfiber® Compression Staple | 2024 |
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 46 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 12 of the 108 ancestors have a recall of any class.
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. 2025, 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 OSSIOfiber® Suture Anchors 2.5-3.5 mm, are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Specific indications are listed below: » Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis…
Read the full statement (170 words)
The OSSIOfiber® Suture Anchors 2.5-3.5 mm, are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Specific indications are listed below:
» Shoulder: Rotator Cuff Repairs, 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, Joint Capsule Closure
* Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, 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, Lateral Epicondylitis Repair (Tennis Elbow)
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/K243760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243760: OSSIOfiber® Suture Anchor 2.5-3.5 mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243760
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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