Auxilock PEEK Optima Screw-In Suture Anchor
The AUXILOCK 4.5 mm PEEK OPTIMA Screw-In Suture Anchor attaches soft tissue to bone in adult patients. This configuration carries two size 2 BioBraid sutures and MO-6 needles for passing…
The AUXILOCK 4.5 mm PEEK OPTIMA Screw-In Suture Anchor attaches soft tissue to bone in adult patients. This configuration carries two size 2 BioBraid sutures and MO-6 needles for passing the sutures through tissue during repair.
The nonabsorbable PEEK anchor is fully threaded, with dual threads that engage cortical and cancellous bone. It comes preloaded on a disposable inserter. A flat tip protects the sutures and assists insertion.
Listed Item
AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid: White & White/Blue, with Needles: MO-6
Materials and Supply
The anchor uses implant grade PEEK OPTIMA LT1, and the BioBraid sutures are made from ultrahigh molecular weight polyethylene. The implant is supplied sterile after ethylene oxide processing for single use. Its sutures are intended to remain part of the assembled implant rather than be used separately.
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) | K213110 |
| Record published | 2026-01-20 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6-016-01 | 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.