510(k) · Cleared
ClearedSECULOK™ Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 9, 2018 as substantially equivalent to K070758 (Stryker Endoscopy, 2007) and 3 other predicates after a 140-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Aug 9, 2018
- Review
- 140 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K911837 (1991). 136 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 6 generations between
- 3 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 2 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 1 generation backK101100 Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502…Conmed Linvatec · 2010 · Recalled
- This deviceK180759 SECULOK™ Suture AnchorU&I Corporation · 2018
Show all 10 generations
- Root · 10 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 9 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 8 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 7 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 6 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 5 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 4 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 3 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 2 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 1 generation backK101100 Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502…Conmed Linvatec · 2010 · Recalled
- This deviceK180759 SECULOK™ Suture AnchorU&I Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −9 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −8 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −7 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −6 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −5 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −4 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −3 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −2 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| −1 | K101100 | Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503… | Conmed Linvatec | 2010 | 2 |
| 0 (this device) | K180759 | SECULOK™ Suture Anchor | U&I Corporation | 2018 | — |
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 | 19 | 0 |
| 1997 | 11 | 0 |
| 1998 | 13 | 0 |
| 1999 | 9 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K070758 | Stryker Peek Zip Suture AnchorSummary page 4…CFR §888.3040) Common Name: Fastener, Fixation, Nondegradable, Soft Tissue Product Code: MBI Predicate Devices: Stryker PEEK ZIP Anchor (K070758) [Primary] CONMED CrossFT BC Suture Anchor (K101100) Stryker ReelX STT® Knotles… | 2007 |
| * | K101100 | Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Summary page 4…Soft Tissue Product Code: MBI Predicate Devices: Stryker PEEK ZIP Anchor (K070758) [Primary] CONMED CrossFT BC Suture Anchor (K101100) Stryker ReelX STT® Knotless Anchor System (K120824) Arthrex PushLock™(K101679)… | 2010 |
| * | K120824 | 3.9MM Reelx STT Suture Anchor SystemSummary page 4…EEK ZIP Anchor (K070758) [Primary] CONMED CrossFT BC Suture Anchor (K101100) Stryker ReelX STT® Knotless Anchor System (K120824) Arthrex PushLock™(K101679) Description of Device: The SECULOK™ Suture Anchor consists of two types, Su… | 2012 |
| * | K101679 | Arthrex Pushlock AnchorsSummary page 4…CONMED CrossFT BC Suture Anchor (K101100) Stryker ReelX STT® Knotless Anchor System (K120824) Arthrex PushLock™(K101679) Description of Device: The SECULOK™ Suture Anchor consists of two types, Suture Anchor and Knotless Anchor. The Suture Anchor i… | 2010 |
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 27 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 16 of the 136 ancestors have a recall of any class.
- 1 other device also cites its predicate K070758.
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. 2018, 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?
SECULOK™ Suture Anchor is for fixation or reattachment of soft tissue including ligament and tendon to bone especially with below indications. - Shoulder: Bankart repair, SLAP lesion repair, Acromio-Clavicular separation repair, Rotator Cuff repair, Capsular shift or Capsulolabral reconstruction, Biceps tenodesis, Deltoid repair. - Foot/Ankle: Medial or lateral stabilization, Achilles tendon repair. - Elbow/Wrist/Hand: Ulnar or Radial collateral ligament…
Read the full statement (91 words)
SECULOK™ Suture Anchor is for fixation or reattachment of soft tissue including ligament and tendon to bone
especially with below indications.
- Shoulder:
Bankart repair, SLAP lesion repair, Acromio-Clavicular separation repair, Rotator Cuff repair, Capsular shift or
Capsulolabral reconstruction, Biceps tenodesis, Deltoid repair.
- Foot/Ankle:
Medial or lateral stabilization, Achilles tendon repair.
- Elbow/Wrist/Hand:
Ulnar or Radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment.
- Knee:
Extra-capsular repairs: Medial/lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis
Patellar realignment and tendon repairs : Vastus medialis obliquous advancement
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180759: SECULOK™ Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180759
Report an extraction error
Are you the manufacturer?
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