510(k) · Cleared
ClearedOSSIOfiber® Suture Anchor
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 Feb 24, 2026 as substantially equivalent to K251309 (OSSIO, Ltd., 2025) after a 69-day review. Its family tree reaches back 14 generations to 1979.
- Decided
- Feb 24, 2026
- Review
- 69 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K792022 (1979). 94 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations between
- 3 generations backK193503 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2020
- 2 generations backK213415 OSSIOfiber Suture AnchorOSSIO, Ltd. · 2022
- 1 generation backK251309 OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2025
- This deviceK254055 OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
Show all 14 generations
- Root · 14 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 13 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 12 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 11 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 10 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 9 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 8 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 7 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 6 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 5 generations backK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- 4 generations backK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- 3 generations backK193503 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2020
- 2 generations backK213415 OSSIOfiber Suture AnchorOSSIO, Ltd. · 2022
- 1 generation backK251309 OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2025
- This deviceK254055 OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −13 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −12 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −11 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −10 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −9 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −8 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| −7 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| −6 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| −5 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| −4 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
| −3 | K193503 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2020 | — |
| −2 | K213415 | OSSIOfiber Suture Anchor | OSSIO, Ltd. | 2022 | — |
| −1 | K251309 | OSSIOfiber® Suture Anchor | OSSIO, Ltd. | 2025 | — |
| 0 (this device) | K254055 | OSSIOfiber® Suture Anchor | OSSIO, Ltd. | 2026 | — |
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 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K251309 | OSSIOfiber® Suture AnchorSummary page 5…ances and accessories Regulatory Class: Class II, 21 C.F.R. § 888.3030 Product Code: MAI Primary Predicate: OSSIOfiber® Suture Anchor (K251309) Reference Devices: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OS… | 2025 |
| † | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable… | 2023 |
| † | K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | 2025 |
| † | K252022 | OSSIOfiber® Interference Screw | 2025 |
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 47 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 12 of the 94 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. 2026, 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 are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, 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, in the following procedures: • Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation…
Read the full statement (170 words)
The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, 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, 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis, Quadriceps Tendon Repair and Meniscal Root Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 Anchors only).
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254055 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254055: OSSIOfiber® Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254055
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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