Auxilock® 3.5mm Titanium Screw-In Suture Anchor With Two #2 BioBraid: White/Blue
The Auxilock 3.5 mm Titanium Screw-In Suture Anchor attaches soft tissue to bone during orthopedic repair in adults. Its threaded, tapered body fixes within bone and supports the attached…
The Auxilock 3.5 mm Titanium Screw-In Suture Anchor attaches soft tissue to bone during orthopedic repair in adults. Its threaded, tapered body fixes within bone and supports the attached #2 BioBraid sutures used to secure the repaired tissue.
The nonabsorbable titanium alloy anchor is supplied preassembled on an appropriately sized inserter. Its self-tapping screw design provides mechanical anchorage. The implant is supplied sterile following ethylene oxide sterilization and is intended for a single use.
Listed Item
AUXILOCK® 3.5mm Titanium Screw-In Suture Anchor With Two #2 BioBraid: White/Blue & White/Black
Repair Applications
Indications include selected shoulder, foot and ankle, elbow, wrist, hand, knee and hip repairs, including rotator cuff and labral repairs, tendon reattachment and ligament reconstruction. The BioBraid suture is used with the assembled implant rather than as a standalone product.
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 | Auxein medical Private limited, India |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K213104 |
| Record published | 2026-04-30 |
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 |
| Storage | Storage environment humidity 10 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6-005-02 | 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 |
|---|---|
| K213110 | 2022-12-16 |
| K213018 | 2022-11-18 |
| K213109 | 2022-08-22 |
| K213104 | 2022-07-29 |
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.