510(k) · Cleared
ClearedSurelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with Inserter, 2.2MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cayenne Medical, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 30, 2013 as substantially equivalent to K111779 (Conmed Linvatec, 2011) and 4 other predicates after a 108-day review. Its family tree reaches back 10 generations to 1991. 7 later devices descend from it.
- Decided
- Dec 30, 2013
- Review
- 108 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K911837 (1991). 97 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 1 citing it directly.
- 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 backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- This deviceK132867 Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture…Cayenne Medical, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK151068 SureLock W Suture AnchorCayenne Medical, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK172186 BioWick X Implant with DriverCayenne Medical, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK183236 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2019
- Descendant · 4 generations on · 2 of its ownK201414 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2020
- Descendant · 4 generations on · 1 of its ownK231641 Rotium Bioresorbable WickNanofiber Solutions, LLC · 2023
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 backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- This deviceK132867 Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture…Cayenne Medical, Inc. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151068SureLock W Suture AnchorCayenne Medical, Inc. · 2015 · cites it directly6descendants
- K172186BioWick X Implant with DriverCayenne Medical, Inc. · 2017 · 2 generations on4descendants
- K183236Rotium Bioresorbable WickNanofiber Solutions, LLC · 2019 · 3 generations on3descendants
- K201414Rotium Bioresorbable WickNanofiber Solutions, LLC · 2020 · 4 generations on2descendants
- K231641Rotium Bioresorbable WickNanofiber Solutions, LLC · 2023 · 4 generations on1descendant
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 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| 0 (this device) | K132867 | Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor… | Cayenne Medical, Inc. | 2013 | — |
| +1 | K151068 | SureLock W Suture Anchor | Cayenne Medical, Inc. | 2015 | — |
| +2 | K172186 | BioWick X Implant with Driver | Cayenne Medical, Inc. | 2017 | — |
| +3 | K183236 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2019 | — |
| +4 | K201414 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2020 | — |
| +4 | K231641 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111779 | Y-Knot All-Suture Anchor Model HF13 | 2011 |
| Kept off the family tree | K100006 | FDA’s K100006 is HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K040472 | Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical SutureSummary page 5…K132867 (PAGE 5/5) 5 10(k) Summary SureLockTM All-Suture Anchor (K040472, K070673, K092533, and K 100506). The substantial equivalence of SureLockTM All-Suture Anchor is based on similarities in indicat… | 2004 |
| * | K070673 | Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureSummary page 5…K132867 (PAGE 5/5) 5 10(k) Summary SureLockTM All-Suture Anchor (K040472, K070673, K092533, and K 100506). The substantial equivalence of SureLockTM All-Suture Anchor is based on similarities in indications for… | 2007 |
| * | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesSummary page 5…K132867 (PAGE 5/5) 5 10(k) Summary SureLockTM All-Suture Anchor (K040472, K070673, K092533, and K 100506). The substantial equivalence of SureLockTM All-Suture Anchor is based on similarities in indications for use, inte… | 2009 |
| * | K100506 | Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures…Summary page 5…K132867 (PAGE 5/5) 5 10(k) Summary SureLockTM All-Suture Anchor (K040472, K070673, K092533, and K 100506). The substantial equivalence of SureLockTM All-Suture Anchor is based on similarities in indications for use, intended use, desi… | 2010 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151068 | SureLock W Suture Anchor | 2015 | 6 |
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 22 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 14 of the 97 ancestors have a recall of any class.
- Of its descendants, K151068 (Cayenne Medical, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K111779.
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. 2013, 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 Cayenne Medical, Inc. SureLockm All- Suture Anchor is intended to rcattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can 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…
Read the full statement (240 words)
The Cayenne Medical, Inc. SureLockm All- Suture Anchor is intended to rcattach soft tissue to bone in orthopedic surgical procedures. The system may be used in either arthroscopic or open surgical procedures. After the anchor is deployed in the bone, the floating sutures can 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.
The Cayenne Medical, Inc. SurcLockTh All-Suture Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:
Shoulder
- Capsular stabilization
o Bankart repair
o Anterior shoulder instability
o, SLAP lesion repairs
o Capsular shift or capsulalabral reconstructions
- Acromioclavicular separation repairs
- Deltoid repairs
- Rotator cuff repairs
- Biceps tenodesis
Foot and Ankle
- Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- Mid and forefoot reconstructions
- Metatarsal ligament/tendon repairs/reconstructions
- Bunionectomy
Elbow
- Ulnar or radial collateral ligament reconstruction
- Lateral epicondylitis repair
- Biceps tendon repair
Hand and Wrist
- Collateral ligament repair
- Scapholunate ligament reconstruction
- Volar plate reconstruction
- Tendon transfers in phalanx
Hip
- Acetabular labral repair
Knee
- Extra-capsular repairs
o Medial collateral ligament
o Lateral collateral ligament
o Posterior oblique ligament
- Patellar realignment and tendon repairs
- lliotibial band tenodesis
- VMO, advancement
- Joint capsule closure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132867: Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with Inserter, 2.2MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132867
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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