ZipE Knotless Tissue Repair and Attachment Devices
The ZipE suture-capture components retain tissue during knotless repair. A resorbable button-like capture advances over pre-tied protuberances on a braided suture and locks against backward…
The ZipE suture-capture components retain tissue during knotless repair. A resorbable button-like capture advances over pre-tied protuberances on a braided suture and locks against backward movement. The implantable capture and suture are distinct from the nitinol holders and stainless-steel insertion driver.
The system is intended for tissue-to-bone or tissue-to-tissue fixation. Its suture is #2 ultra-high-molecular-weight polyethylene. The broader system can include a titanium screw or biocomposite bone anchor, while individual products may be supplied separately.
Listed Item
Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4 , # 4 resorbable captures/capture holster, 2 #2 USP UHMWPE braided suture, two thermoplastic tip covers
Repair Configurations
Applications include specified shoulder, foot and ankle, knee, hand and wrist, and elbow repairs. The driver moves the capture forward along the suture to secure the tissue. Tip protectors and capture holders are delivery components rather than implanted fixation elements.
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Ziptek LLC, United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K162429 |
| Record published | 2024-06-03 |
| Record revised | 2019-03-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Rb41-S-4 | In distribution | |
| RA6-6550-S | In distribution | |
| RA6-6550-S | In distribution | |
| RA6-6565-S | In distribution | |
| RA6-6565-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 545 |
| Fix2Lock | Osteonic Co., Ltd. | 118 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 110 |
| Reunite Screw System | Biomet Orthopedics | 85 |
| ComposiTCP | S.B.M | 61 |
| ActivaScrew™ Interference | Bioretec Ltd. | 54 |
| Ligafix | S.B.M | 40 |
| Twinfix | Smith & Nephew, Inc. | 28 |
| Biosure | Smith & Nephew, Inc. | 27 |
| TorqLoc Interference | Bioretec Ltd. | 27 |
| FiberFIX | Nanova BIO Materials Inc | 25 |
| AlphaVent | Stryker GmbH | 23 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162429 | 2017-03-13 |
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.