510(k) · Cleared
ClearedEndopearl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Apr 29, 1999 after a 160-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Apr 29, 1999
- Review
- 160 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK984171 EndopearlLinvatec Corp. · 1999
- Descendant · cites it directly · 5 of its ownK993339 Endopearl with ThreaderLinvatec Corp. · 1999
- Descendant · 2 generations on · 4 of its ownK012469 Resorbable NO Profile Screw and WasherBiomet Manufacturing, Inc. · 2001
- Descendant · 3 generations on · 3 of its ownK021832 Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc. · 2002
- Descendant · 4 generations on · 2 of its ownK033233 Lactosorb Tibial L-15 Screw and WasherBiomet, Inc. · 2003
- Descendant · 5 generations on · 0 of its ownK130731 Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K993339Endopearl with ThreaderLinvatec Corp. · 1999 · cites it directly5descendants
- K012469Resorbable NO Profile Screw and WasherBiomet Manufacturing, Inc. · 2001 · 2 generations on4descendants
- K021832Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & WasherBiomet, Inc. · 2002 · 3 generations on3descendants
- K033233Lactosorb Tibial L-15 Screw and WasherBiomet, Inc. · 2003 · 4 generations on2descendants
- K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984171 | Endopearl | Linvatec Corp. | 1999 | — |
| +1 | K993339 | Endopearl with Threader | Linvatec Corp. | 1999 | — |
| +2 | K012469 | Resorbable NO Profile Screw and Washer | Biomet Manufacturing, Inc. | 2001 | — |
| +3 | K021832 | Arthrotek Resorbable NO-Profile Lactosorb L-15 Screw & Washer | Biomet, Inc. | 2002 | — |
| +4 | K033233 | Lactosorb Tibial L-15 Screw and Washer | Biomet, Inc. | 2003 | — |
| +5 | K130731 | Stabiliz Fixation System - SPL Locking Screw | Stabiliz Orthopaedics, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | EndoButton Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993339 | Endopearl with Threader | 1999 | 5 |
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, K993339 (Linvatec Corp., 1999) has gone furthest, with 5 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?
The EndoPearl is used in conjunction with the Linvatec BioScrew bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of ACL/PCL reconstruction.
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/K984171 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984171: Endopearl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984171
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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