SureLock™
The FDA filing describes the SureLock All-Suture Anchor as a manually operated, single-procedure device for reattaching soft tissue to bone. The anchor is preloaded with floating suture and…
The FDA filing describes the SureLock All-Suture Anchor as a manually operated, single-procedure device for reattaching soft tissue to bone. The anchor is preloaded with floating suture and mounted on a disposable inserter.
The filing lists 1.4 mm and 2.2 mm sizes and describes use in arthroscopic or open orthopedic procedures. After deployment in bone, the floating sutures can reattach soft tissue such as ligaments, tendons or joint capsules.
Listed Item
SureLock™ All-Suture Anchor, 2.2mm pre-loaded implant, Flexible Inserter
Inserter Action
The inserter pushes the anchor construct into a drilled bone hole. Turning its knob tensions the floating suture to expand and deploy the anchor in the bone tunnel.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Renolit Hansen Packaging Tech. (BJ) Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Cayenne Medical, Inc., United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K132867 |
| Record published | 2015-10-09 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CM-9622 | In distribution | |
| CM-9622F | In distribution | |
| CM-9614F | In distribution | |
| CM-9614 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors | GM DOS Reis Industria E Comercio Ltda | 78 |
| Juggerknot® | Biomet Orthopedics | 77 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Parcus Medical, LLC | 74 |
| endophix | Suzhou Endophix Co., Ltd. | 71 |
| Titan | Medline Industries, Inc. | 68 |
| TopLock | Fusion Orthopedics, LLC | 67 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192428 | 2019-10-05 |
| K180274 | 2018-03-21 |
| K172186 | 2017-10-16 |
| K161033 | 2016-08-03 |
| K151068 | 2015-07-24 |
| K143473 | 2015-03-25 |
| K143392 | 2015-01-23 |
| K132867 | 2013-12-30 |
| K131325 | 2013-08-16 |
| K122314 | 2012-10-31 |
| K122463 | 2012-10-11 |
| K112814 | 2012-01-17 |
| K112960 | 2012-01-09 |
| K112876 | 2011-12-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.