510(k) · Cleared
ClearedBioroc EZ Suture Bone Fastener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasive Devices, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Feb 18, 1998 after a 163-day review. The FDA summary names its predicate without a number. 85 later devices descend from it.
- Decided
- Feb 18, 1998
- Review
- 163 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 0
85 later devices descend from it, 3 citing it directly.
- This deviceK973381 Bioroc EZ Suture Bone FastenerInnovasive Devices, Inc. · 1998
- Descendant · cites it directly · 84 of its ownK984490 Sutureless AnchorInnovasive Devices, Inc. · 1999
- Descendant · cites it directly · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- Descendant · cites it directly · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- Descendant · 2 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- Descendant · 2 generations on · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
Showing 5 of 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · See all- K984490Sutureless AnchorInnovasive Devices, Inc. · 1999 · cites it directly84descendants
- K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · cites it directly78descendants
- K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · cites it directly77descendants
- K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd. · 2004 · 2 generations on76descendants
- K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · 2 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973381 | Bioroc EZ Suture Bone Fastener | Innovasive Devices, Inc. | 1998 | — |
| +1 | K984490 | Sutureless Anchor | Innovasive Devices, Inc. | 1999 | — |
| +1 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| +1 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| +2 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| +2 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 8 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | 2.8mm and 3.5mm Innovasive Devices ROC EZ Suture Bone Fastener Named without a submission number | |
| * | — | Bio-Anchor Named without a submission number |
What descends from it? (85)
See all 853 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K984490 (Innovasive Devices, Inc., 1999) has gone furthest, with 84 descendants of its own.
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.
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?
SHOULDER Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair KNEE Extra-capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB…
Read the full statement (80 words)
SHOULDER
Bankart repair
Repair of rotator cuff tears
Capsular instability
Slap lesion repair
Acromio-clavicular separation
Capsule shift/capsulolabral reconstruction
Biceps tenodesis
Deltoid repair
KNEE
Extra-capsular repairs
Reattachment of medial collateral ligament
Reattachment of lateral collateral ligament
Reattachment of posterior oblique ligament
Joint capsule closure
Patellar ligament and tendon avulsion repairs
Extra-capsular reconstruction
ITB tenodesis.
ANKLE
Lateral and medial instability
Achilles tendon reconstruction and repair
Mid-foot reconstructions.
FOOT
Hallux valgus reconstruction
ELBOW
Tennis elbow repair
Biceps tendon reattachment
Medial and lateral repairs
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/K973381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973381: Bioroc EZ Suture Bone Fastener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973381
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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