510(k) · Cleared
Recalled · Class II · 2017Conmed Linvatec Soft Tissue to Bone System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 23, 2009 as substantially equivalent to K963812 (Li Medical Technologies, Inc., 1996) and 2 other predicates after a 27-day review. Its family tree reaches back 8 generations to 1991. 56 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K911837 (1991). 68 ancestors in all, the oldest K792022 (1979). 56 later devices descend from it, 6 citing it directly.
- 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 deviceK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009
- Descendant · cites it directly · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- Descendant · 2 generations on · 17 of its ownK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- Descendant · 3 generations on · 12 of its ownK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014
- Descendant · cites it directly · 9 of its ownK163258 CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation · 2017
- Descendant · cites it directly · 9 of its ownK112965 Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011 · Recalled
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · cites it directly29descendants
- K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 2 generations on17descendants
- K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation · 2014 · 3 generations on12descendants
- K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation · 2017 · cites it directly9descendants
- K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec · 2011 · cites it directly9descendants
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) | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | — |
| +1 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| +2 | K131035 | Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM | Linvatec Corporation D/B/A Conmed Linvatec | 2013 | — |
| +3 | K133224 | Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2… | Conmed Corporation | 2014 | — |
| +1 | K163258 | CrossFT Knotless Suture Anchor with Disposable Driver | Conmed Corporation | 2017 | — |
| +1 | K112965 | Nano Suture Anchor | Linvatec Corporation D/B/A Conmed Linvatec | 2011 | 6 |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K963812 | LM Bone Anchor (Orthopedics)Summary page 1…M Bone Anchor (renamed ConMed Linvatec Ultrafix RC®) Company Name: Li Medical Technologies Inc (purchased by ConMed Linvatec) 510(k)#: K963812 Device Name: ThRevo ® Anchor, Disposable Driver, Hi-FiTM Sutures Company Name: ConMed Linvatec… | 1996 |
| * | K073481 | Threvo Anchor, Disposable Driver, HI-FI SuturesSummary page 1…K963812 Device Name: ThRevo ® Anchor, Disposable Driver, Hi-FiTM Sutures Company Name: ConMed Linvatec 510(k)#: K073481 Device Name: ConMed Linvatec Bio Mini-Revo ® Company Name: ConMed Linvatec 510(k)#:… | 2008 |
| * | K053561 | Bio-Mini Revo Suture AnchorSummary page 1…510(k)#: K073481 Device Name: ConMed Linvatec Bio Mini-Revo ® Company Name: ConMed Linvatec 510(k)#: K053561 5-1… | 2006 |
What descends from it? (56)
See all 566 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111779 | Y-Knot All-Suture Anchor Model HF13 | 2011 | 29 |
| K163258 | CrossFT Knotless Suture Anchor with Disposable Driver | 2017 | 9 |
| K112965 | Nano Suture Anchor | 2011 | 9 |
| K101100 | Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 | 2010 | 5 |
| K222589 | Flexible Suturing System with Anchors (FSSA) | 2023 | 0 |
| K181120 | 2.8 mm/3.3 mm PopLok Suture Anchors | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2017 | Class II | Z-0253-2018 | Mixed-up of materials/components | Manufactured with the incorrect anchor outer body |
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 68 ancestors have a recall of any class.
- Of its descendants, K111779 (Conmed Linvatec, 2011) has gone furthest, with 29 descendants of its own.
- 1 other device also cites its predicate K963812.
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. 2009, 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 ConMed Linvatec Soft Tissue to Bone System 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, 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/K091549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091549: Conmed Linvatec Soft Tissue to Bone System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091549
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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