510(k) · Cleared
ClearedOSSIOfiber® Interference Screw
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 Aug 19, 2025 as substantially equivalent to K202535 (Arthrex, Inc., 2020) and 1 other predicate after a 50-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Aug 19, 2025
- Review
- 50 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K961555 (1996). 45 ancestors in all, the oldest K915424 (1993). No later device cites it as a predicate yet.
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations between
- 3 generations backK143660 Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
- 2 generations backK161001 MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL · 2016
- 1 generation backK240441 MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek · 2024
- This deviceK252022 OSSIOfiber® Interference ScrewOSSIO, Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 9 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 8 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 7 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 6 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 5 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- 4 generations backK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
- 3 generations backK143660 Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
- 2 generations backK161001 MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL · 2016
- 1 generation backK240441 MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek · 2024
- This deviceK252022 OSSIOfiber® Interference ScrewOSSIO, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −9 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −8 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −7 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −6 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −5 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| −4 | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an | Smith & Nephew, Inc. | 2012 | — |
| −3 | K143660 | Milagro / Milagro Advance Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2015 | — |
| −2 | K161001 | MILAGRO ADVANCE PEEK Interference Screw | Medos International SARL | 2016 | — |
| −1 | K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | Depuy Mitek | 2024 | — |
| 0 (this device) | K252022 | OSSIOfiber® Interference Screw | OSSIO, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K202535 | Arthrex FastThread Interference ScrewSummary page 5…appliances and accessories Regulatory Class: Class II, 21 C.F.R. § 888.3030 Product Code: MAI Primary Predicate: Arthrex FastThread Interference Screw (K202535) Additional Predicate: MILAGRO BR Interference Screws (5x23mm, 5x30mm, 6x23mm, 6x30… | 2020 |
| * | K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewSummary page 5…tThread Interference Screw (K202535) Additional Predicate: MILAGRO BR Interference Screws (5x23mm, 5x30mm, 6x23mm, 6x30mm) (K240441) Reference Devices: OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw,… | 2024 |
| † | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable… | 2023 |
| † | K243760 | OSSIOfiber® Suture Anchor 2.5-3.5 mm | 2025 |
| † | K251309 | OSSIOfiber® Suture Anchor | 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 29 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 45 ancestors have a recall of any class.
- 1 other device also cites its predicate K202535.
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® Interference Screws, are indicated for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone 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. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate…
Read the full statement (191 words)
The OSSIOfiber® Interference Screws, are indicated for fixation of tissue, including ligament or tendon to bone, or a bone/tendon to bone 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. Interference fixation is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate; Specifically:
• 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, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
• Knee: Repair/Reconstruction of the Anterior Cruciate Ligament, Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Patellar Tendon, Posterior Oblique Ligament, Iliotibial Band Tenodesis, MPFL
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252022: OSSIOfiber® Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252022
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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