510(k) · Cleared
Recalled · Class II · 2026Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Aug 26, 2010 as substantially equivalent to K091549 (Linvatec Corp., 2009) and 2 other predicates after a 128-day review. Its family tree reaches back 9 generations to 1991. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 26, 2010
- Review
- 128 days
- Class
- Class II
- Product code
- MAI
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 9 generations to K911837 (1991). 98 ancestors in all, the oldest K792022 (1979). 5 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 deviceK101100 Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502…Conmed Linvatec · 2010
- Descendant · cites it directly · 2 of its ownK170501 CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation · 2017
- Descendant · 2 generations on · 1 of its ownK171592 CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation · 2017
- Descendant · cites it directly · 0 of its ownK180759 SECULOK™ Suture AnchorU&I Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK180763 CuffLink Implant System BiocompositeConmed Corporation · 2018
- Descendant · cites it directly · 0 of its ownK121890 Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2012
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 deviceK101100 Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502…Conmed Linvatec · 2010
Most influential descendants
Showing 5 of 5 · See all- K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation · 2017 · cites it directly2descendants
- K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation · 2017 · 2 generations on1descendant
- K180759SECULOK™ Suture AnchorU&I Corporation · 2018 · cites it directly0descendants
- K180763CuffLink Implant System BiocompositeConmed Corporation · 2018 · 3 generations on0descendants
- K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2012 · cites it directly0descendants
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) | K101100 | Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503… | Conmed Linvatec | 2010 | — |
| +1 | K170501 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver | Conmed Corporation | 2017 | — |
| +2 | K171592 | CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver | Conmed Corporation | 2017 | — |
| +1 | K180759 | SECULOK™ Suture Anchor | U&I Corporation | 2018 | — |
| +3 | K180763 | CuffLink Implant System Biocomposite | Conmed Corporation | 2018 | — |
| +1 | K121890 | Genesys Pressft Suture Anchor | Linvatec Corporation D/B/A Conmed Linvatec | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 11 | 0 |
| 1996 | 18 | 0 |
| 1997 | 11 | 0 |
| 1998 | 12 | 0 |
| 1999 | 8 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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? (3)
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 1…ate/Legally Marketed Devices Device Name: ConMed Linvatec Soft Tissue to Bone System Company Name: ConMed Linvatec 510O(k) #: K091549 Device Name: ConMed Linvatec Bio Mini-Revo Company Name: ConMed Linvatec 510O(k) # K… | 2009 |
| * | K053561 | Bio-Mini Revo Suture AnchorSummary page 1…nvatec 510O(k) #: K091549 Device Name: ConMed Linvatec Bio Mini-Revo Company Name: ConMed Linvatec 510O(k) # K053561 Device Name: ConMed Linvatec Matryx Interference Screw Company Name: ConMed Linvatec 510O(k)#… | 2006 |
| * | K052080 | Matryx Interference ScrewSummary page 1…0O(k) # K053561 Device Name: ConMed Linvatec Matryx Interference Screw Company Name: ConMed Linvatec 510O(k)# K052080 KIII Ol p-2. of~2. E. Device Description The ConMed Linvatec CrossFT Tm BC… | 2005 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2026 | Class II | Z-3018-2026 | Labeling design | Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. |
| Mar 6, 2013 | Class II | Z-1619-2013 | Mixed-up of materials/components | Incorrect blue/white suture was used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 98 ancestors have a recall of any class.
- Of its descendants, K170501 (Conmed Corporation, 2017) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K091549.
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. 2010, 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 ConMed Linvatec CrossFTTM BC Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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, tendon, 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/K101100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101100: Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101100
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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