510(k) · Cleared
ClearedConmed Linvatec Paladin, Preloaded with Two #2 HI-FI Sutures
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 10, 2009 as substantially equivalent to K042966 (Linvatec Biomaterials, Ltd., 2004) and 1 other predicate after a 74-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Apr 10, 2009
- Review
- 74 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K911837 (1991). 55 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 7 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 6 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 5 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 4 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 3 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 2 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 1 generation backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- This deviceK090186 Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −7 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −6 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −5 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −4 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −3 | 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 | — |
| −1 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| 0 (this device) | K090186 | Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI Sutures | Linvatec Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Summary page 1…Predicate/Legally Marketed Devices Device Name: ConMed Linvatec Duet Suture Anchor Company Name: ConMed Linvatec 510(k) #: K042966 Device Name: ConMed Linvatec Bio Mini-Revo Suture Anchor Company Name: ConMed Linvatec 510(k) #… | 2004 |
| * | K053561 | Bio-Mini Revo Suture AnchorSummary page 1…#: K042966 Device Name: ConMed Linvatec Bio Mini-Revo Suture Anchor Company Name: ConMed Linvatec 510(k) #: K053561 )4,jo l-~s 6 (f 2 o&2 E. Device Description The ConMed Linvatec Paladi… | 2006 |
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 18 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 55 ancestors have a recall of any class.
- 1 other device also cites its predicate K042966.
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. 2009, 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 device may be used in either arthroscopic or open surgical procedures.
After the suture is anchored to the bone, it may be used to reattach soft
tissue, such as ligaments, tendons, or joint capsules to the bone. The suture
anchor system thereby stabilizes the damaged soft tissue, in conjunction with
appropriate postoperative immobilization, throughout the healing period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090186 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090186: Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090186
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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