510(k) · Cleared
ClearedCrossFT Knotless Suture Anchor with Disposable Driver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 25, 2017 as substantially equivalent to K091549 (Linvatec Corp., 2009) after a 65-day review. Its family tree reaches back 9 generations to 1991. 9 later devices descend from it.
- Decided
- Jan 25, 2017
- Review
- 65 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K911837 (1991). 69 ancestors in all, the oldest K792022 (1979). 9 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 5 generations between
- 3 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 2 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 1 generation backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- This deviceK163258 CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation · 2017
- Descendant · cites it directly · 6 of its ownK220757 Argo Knotless SP AnchorConmed Corporation · 2022
- Descendant · 2 generations on · 2 of its ownK240090 Argo Knotless GENESYS AnchorConmed Corporation · 2024
- Descendant · 3 generations on · 1 of its ownK244025 Argo Knotless GENESYS AnchorConmed Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK251296 The Acumed Wrist Fixation SystemAcumed, LLC · 2025 · Recalled
Show all 9 generations
- Root · 9 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 8 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 7 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 6 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 5 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 4 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 3 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 2 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 1 generation backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- This deviceK163258 CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K220757Argo Knotless SP AnchorConmed Corporation · 2022 · cites it directly6descendants
- K240090Argo Knotless GENESYS AnchorConmed Corporation · 2024 · 2 generations on2descendants
- K244025Argo Knotless GENESYS AnchorConmed Corporation · 2025 · 3 generations on1descendant
- K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025 · 3 generations on0descendants
- K251296The Acumed Wrist Fixation SystemAcumed, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −8 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −7 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −6 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −5 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −4 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −3 | 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 | — |
| −1 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| 0 (this device) | K163258 | CrossFT Knotless Suture Anchor with Disposable Driver | Conmed Corporation | 2017 | — |
| +1 | K220757 | Argo Knotless SP Anchor | Conmed Corporation | 2022 | — |
| +2 | K240090 | Argo Knotless GENESYS Anchor | Conmed Corporation | 2024 | — |
| +3 | K244025 | Argo Knotless GENESYS Anchor | Conmed Corporation | 2025 | — |
| +3 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025 | — |
| +2 | K251296 | The Acumed Wrist Fixation System | Acumed, LLC | 2025 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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 |
|---|---|---|---|
| * | K091549 | Conmed Linvatec Soft Tissue to Bone SystemSummary page 4…Device Name: CrossFT™ Suture Anchor with Disposable Driver Company Name: CONMED Linvatec 510(k) #: K091549 IV. DEVICE DESCRIPTION The CrossFT™ Knotless Suture Anchors with Disposable Driver are sterile, single use… | 2009 |
What descends from it? (9)
3 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?
- The line of descent spans 26 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 69 ancestors have a recall of any class.
- Of its descendants, K220757 (Conmed Corporation, 2022) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K091549.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The CrossFT™ Knotless Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. 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/K163258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163258: CrossFT Knotless Suture Anchor with Disposable Driver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163258
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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