Fixone All Suture Anchor
Fixone All Suture Anchor reattaches soft tissue to bone during orthopedic surgery. Sutures secured to bone provide attachment for ligaments, tendons or joint capsules. The system is…
Fixone All Suture Anchor reattaches soft tissue to bone during orthopedic surgery. Sutures secured to bone provide attachment for ligaments, tendons or joint capsules. The system is intended to stabilize the damaged tissue together with appropriate postoperative immobilization throughout the healing period.
The anchor consists of a fix suture and one, two or three nonabsorbable sutures. The nonabsorbable strands are made from ultra-high-molecular-weight polyethylene and are preloaded on a handled insertion device for placement.
Listed Item
Fixone All suture anchor consists of one “fix Suture” and one,two or three non-absorbable Sutures. The non-absorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device isprovided sterile, for single use only. This device is medical device. Prescription use only.
Surgical Use
The anchor can be used during arthroscopic or open procedures. It is supplied sterile for a single use and is restricted to prescription use. The sutures remain nonabsorbable after placement.
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 | Aju Pharm Co., Ltd., South Korea |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K222423 |
| Record published | 2025-01-06 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FAS-1652803jw | In distribution | |
| FAM-7615802fg | In distribution | |
| FAF-24615802ig | 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 |
|---|---|
| K233601 | 2024-08-02 |
| K222423 | 2023-03-23 |
| K192709 | 2020-12-15 |
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.