Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors
FIX-MAX ZIP ANCHOR SELF PUNCHING Ø1,9mm 2 TAPES 2,0mm WHITE/BLACK AND WHITE/BLUE 4 NEEDLES 26mm 1/2 CIRCLE CYLINDER TIP
7manufacturers in China registered for this device type
78catalogue numbers in this listing
1510(k) clearance
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 | GM DOS Reis Industria E Comercio Ltda, Brazil |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2024-01-12 |
| Record revised | 2025-12-08 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
|---|---|---|
| Mini Zip Anchor | In distribution | |
| Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Fix-Max Zip Anchor | In distribution | |
| Hip Zip Anchor | In distribution | |
| Mini Zip Anchor | In distribution | |
| Super Max Zip Anchor | In distribution | |
| Zip Anchor | In distribution | |
| Super Max Zip Anchor | In distribution | |
| Super Max Zip Anchor | In distribution | |
| Fix-Max Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Zip Anchor | In distribution | |
| Micro Zip Anchor | In distribution | |
| Mini Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Mini Zip Anchor | In distribution | |
| Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Max HTA | In distribution | |
| Mini Zip Anchor | In distribution | |
| Mini Zip Anchor | In distribution | |
| Hip Zip Anchor | In distribution | |
| Hip Zip Anchor | In distribution | |
| Fix-Max Zip Anchor | In distribution | |
| Super Max Zip Anchor | In distribution | |
| Fix Super Max Zip Anchor | In distribution | |
| Mini Zip Anchor | In distribution | |
| Fix Super Max Zip Anchor | In distribution | |
| Fix-Max Zip Anchor | In distribution | |
| Hip Zip Anchor | In distribution | |
| Zip Anchor | In distribution | |
| Mini Zip Anchor | In distribution | |
| Micro HTA | In distribution | |
| Zip Anchor | In distribution | |
| Fix Super Max Zip Anchor | In distribution | |
| Fix-Max Zip Anchor | In distribution | |
| Micro Zip Anchor | In distribution | |
| Mini Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Nano HTA | In distribution | |
| Hip Zip Anchor | In distribution | |
| TMJ Zip Anchor | In distribution | |
| HTA | In distribution | |
| Max Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Super Max Zip Anchor | In distribution | |
| Zip Anchor | In distribution | |
| Fix Super Max Zip Anchor | In distribution | |
| Micro Zip Anchor | In distribution | |
| Micro Zip Anchor | In distribution | |
| Zip Anchor | In distribution | |
| Mini HTA | In distribution | |
| Mini Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Super Max Zip Anchor | In distribution | |
| HTA | In distribution | |
| Max HTA | In distribution | |
| Max Zip Anchor | In distribution | |
| Mini Zip Anchor | In distribution | |
| Zip Anchor | In distribution | |
| Fix Super Max Zip Anchor | In distribution | |
| Fix Super Max Zip Anchor | In distribution | |
| Fix-Max Zip Anchor | In distribution | |
| Hip Zip Anchor | In distribution | |
| Mini Zip Anchor | In distribution | |
| Zip Anchor | In distribution | |
| Fix Super Max Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Super Max Zip Anchor | In distribution | |
| Super Max Zip Anchor | In distribution | |
| Fix Super Max Zip Anchor | In distribution | |
| Hip Zip Anchor | In distribution | |
| Max Zip Anchor | In distribution | |
| Hip Zip Anchor | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| 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 |
| Twinfix | Smith & Nephew, Inc. | 45 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252664 | 2025-11-04 |
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.