510(k) · Cleared
ClearedecoFIX®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Science & Bio Materials (S.B.M.) Sas · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jul 26, 2023 as substantially equivalent to K180960 (S.B.M. Sas Sciences For Bio Materials, 2018) and 1 other predicate after a 36-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jul 26, 2023
- Review
- 36 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K961555 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 4 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 3 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 2 generations backK170868 FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials · 2017
- 1 generation backK180960 FIXIT / ComposiTCP Threaded Anchor SystemS.B.M. Sas Sciences For Bio Materials · 2018
- This deviceK231787 ecoFIX®Science & Bio Materials (S.B.M.) Sas · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −4 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −3 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −2 | K170868 | FIXIT Threaded Anchor System | S.B.M Sas Science For Bio Materials | 2017 | — |
| −1 | K180960 | FIXIT / ComposiTCP Threaded Anchor System | S.B.M. Sas Sciences For Bio Materials | 2018 | — |
| 0 (this device) | K231787 | ecoFIX® | Science & Bio Materials (S.B.M.) Sas | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K180960 | FIXIT / ComposiTCP Threaded Anchor SystemSummary page 4…mber 888.3030 Product Code MAI | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K180960 FIXIT® / ComposiTCP™ Threaded Anchor System MAI K170868 FIXIT® / ComposiTCP™ Threaded Anchor System MAI Device Description Summar… | 2018 |
| * | K170868 | FIXIT Threaded Anchor SystemSummary page 4…ate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K180960 FIXIT® / ComposiTCP™ Threaded Anchor System MAI K170868 FIXIT® / ComposiTCP™ Threaded Anchor System MAI Device Description Summary 21 CFR 807.92(a)(4) 1. DEVICE DESCRIPTION ecoFIX® is… | 2017 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 9 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. 2023, 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 ecoFIX® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction; Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus…
Read the full statement (119 words)
The ecoFIX® threaded anchor system is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow, the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair; SLAP Lesion Repair; Biceps Tenodesis; Acromio-clavicular Separation Repair; Deltoid Repair; Capsule Shift or Capsulolabral Reconstruction;
Ankle/Foot: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Patellar Tendon Repair; Posterior Oblique Ligament Repair; lliotibial Band Tenodesis;
Wrist/Hand: Scapholunate Ligament Reconstruction; Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Ulnar or Radial Collateral Ligament Reconstruction; Tennis Elbow Repair and Lateral Epicondylitis Repair.
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/K231787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231787: ecoFIX®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231787
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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