510(k) · Cleared
ClearedRotorblade Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Li Medical Technologies, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Sep 23, 1999 as substantially equivalent to K983435 (Li Medical Technologies, Inc., 1999) after a 23-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Sep 23, 1999
- Review
- 23 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950272 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK950272 Panalok Absorbable Suture Anchor SystemETHICON, Inc. · 1996
- 1 generation backK983435 RotorbladeLi Medical Technologies, Inc. · 1999
- This deviceK992938 Rotorblade Suture AnchorLi Medical Technologies, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK993373 Rotorblade Suture AnchorLi Medical Technologies, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K993373Rotorblade Suture AnchorLi Medical Technologies, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950272 | Panalok Absorbable Suture Anchor System | ETHICON, Inc. | 1996 | — |
| −1 | K983435 | Rotorblade | Li Medical Technologies, Inc. | 1999 | — |
| 0 (this device) | K992938 | Rotorblade Suture Anchor | Li Medical Technologies, Inc. | 1999 | — |
| +1 | K993373 | Rotorblade Suture Anchor | Li Medical Technologies, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K983435 | RotorbladeSummary page 1…i Medical, 4 Armstrong Road, Shelton, CT 06484, Rhodemann Li, Vice President August 30, 1999 Unclassified Bone anchor ' Li Medical RotorBlade™ Li Medical RotorBlade™ (K983435) Made from surgical grade PLL (homopolymer poly (L(-) -lactide), the LM Anchor is designed as a propeller blade type anchor devi… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993373 | Rotorblade Suture Anchor | 1999 | 0 |
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 3 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K993373 (Li Medical Technologies, Inc., 1999) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K983435.
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: rotator cuff 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/K992938 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992938: Rotorblade Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992938
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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