510(k) · Cleared
ClearedOTS 25-L (100-5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ots Medical, Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 22, 2025 as substantially equivalent to K241234 (Ots Medical, Ltd., 2025) and 1 other predicate after an 85-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Jul 22, 2025
- Review
- 85 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K911837 (1991). 103 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 10 generations between
- 3 generations backK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014
- 2 generations backK233429 OTS 25 (100-1)Ots Medical, Ltd. · 2023
- 1 generation backK241234 OTS 25-L (100-5)Ots Medical, Ltd. · 2025
- This deviceK251310 OTS 25-L (100-5)Ots Medical, Ltd. · 2025
Show all 14 generations
- Root · 14 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 13 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 12 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 11 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 10 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 9 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 8 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 7 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 6 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 5 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 4 generations backK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- 3 generations backK133224 Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded…Conmed Corporation · 2014
- 2 generations backK233429 OTS 25 (100-1)Ots Medical, Ltd. · 2023
- 1 generation backK241234 OTS 25-L (100-5)Ots Medical, Ltd. · 2025
- This deviceK251310 OTS 25-L (100-5)Ots Medical, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −13 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −12 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −11 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −10 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −9 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −8 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −7 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −6 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| −5 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| −4 | 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 | — |
| −2 | K233429 | OTS 25 (100-1) | Ots Medical, Ltd. | 2023 | — |
| −1 | K241234 | OTS 25-L (100-5) | Ots Medical, Ltd. | 2025 | — |
| 0 (this device) | K251310 | OTS 25-L (100-5) | Ots Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 14 | 0 |
| 1997 | 12 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K241234 | OTS 25-L (100-5)Summary page 6…omparison 21 CFR 807.92(a)(6) L The subject OTS 25-L and predicate cleared OTS 25-L device (K241 234) are identical in all technological characteristics. The only difference between the subject OTS 25-L and the cleared OTS 25-L (K… | 2025 |
| * | K151068 | SureLock W Suture AnchorSummary page 5…�I �I M B -� __ I I K151068 11 Cayenne Medical's Surelock W Suture Anchor… | 2015 |
| † | K233429 | OTS 25 (100-1) | 2023 |
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 34 years and passes through 10 companies; a new generation was cleared every 1.6 years on median.
- 14 of the 103 ancestors have a recall of any class.
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. 2025, 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 non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
The OTS 25-L All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, both may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor system stabilizes the damaged soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251310 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251310: OTS 25-L (100-5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251310
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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