# K132867: Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with Inserter, 2.2MM

- Pathway: 510(k) (Traditional)
- Applicant: Cayenne Medical, Inc.
- Decided: Dec 30, 2013 after 108 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K911837 (1991). 97 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111779: Y-Knot All-Suture Anchor Model HF13, Conmed Linvatec (2011)
- K040472: Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture, Teleflex Medical (2004) Summary page 5.
- K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture, Teleflexmedical, Inc. (2007) Summary page 5.
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures, Beere Precision Medical Instruments, Kmedic, Telef (2009) Summary page 5.
- K100506: Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:X-5000FFK, X-5001FFK, X-5002FFK, Teleflex Medical (2010) Summary page 5.

## Cited in the summary but kept off the family tree
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need, Riverpoint Medical (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K151068: SureLock W Suture Anchor (2015), 6 descendants of its own
- K172186: BioWick X Implant with Driver (2017), 4 descendants of its own
- K183236: Rotium Bioresorbable Wick (2019), 3 descendants of its own
- K201414: Rotium Bioresorbable Wick (2020), 2 descendants of its own
- K231641: Rotium Bioresorbable Wick (2023), 1 descendant of its own

## Indications for use
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

Source page: https://510kreport.com/device/K132867
Methodology: https://510kreport.com/methodology