ActivaScrew™ Interference
ActivaScrew Interference is a bioabsorbable screw that fixes ligament or tendon to bone, or a bone-tendon graft to bone. The fully threaded screw provides interference fixation at the…
ActivaScrew Interference is a bioabsorbable screw that fixes ligament or tendon to bone, or a bone-tendon graft to bone. The fully threaded screw provides interference fixation at the repair site.
The material is poly(L-lactide-co-glycolide), or PLGA. Different screw diameters and lengths provide options for fixation sites in the knee, shoulder, elbow, ankle, foot, hand or wrist.
Listed Item
ActivaScrew™ Interference 10 x 28 mm
Size and Fixation Scope
Diameters range from 4 to 10 mm and lengths from 10 to 33 mm; a listed 10 by 28 mm screw is one configuration. The fixation is used with appropriate immobilization or controlled mobilization.
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 | Bioretec Ltd., Finland |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K130716 |
| Record published | 2015-08-20 |
| Record revised | 2024-01-03 (version 5) |
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 59 to 86 °F; Storage environment temperature 15 to 30 °C |
| Sizes | Width 4 to 10 mm; length 10 to 33 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B-AI-0820 | Width 8 mm | In distribution |
| B-AI-0410 | Width 4 mm | In distribution |
| B-AI-0420 | Length 20 mm | In distribution |
| B-AI-0730 | Length 30 mm | In distribution |
| B-AI-0415 | Length 15 mm | In distribution |
| B-AI-0920 | Length 20 mm | In distribution |
| B-AI-1028 | Width 10 mm | In distribution |
| B-AI-0933 | Length 33 mm | In distribution |
| B-AI-0515 | Length 15 mm | In distribution |
| B-AI-0924 | Width 9 mm | In distribution |
| B-AI-0828 | Width 8 mm | In distribution |
| B-AI-0626 | Length 26 mm | In distribution |
| B-AI-0415 | Length 15 mm | In distribution |
| B-AI-0930 | Width 9 mm | In distribution |
| B-AI-0924 | Width 9 mm | In distribution |
| B-AI-0720 | Width 7 mm | In distribution |
| B-AI-1024 | Length 24 mm | In distribution |
| B-AI-0724 | Length 24 mm | In distribution |
| B-AI-1024 | Length 24 mm | In distribution |
| B-AI-0928 | Width 9 mm | In distribution |
| B-AI-0420 | Length 20 mm | In distribution |
| B-AI-0720 | Width 7 mm | In distribution |
| B-AI-0920 | Length 20 mm | In distribution |
| B-AI-0730 | Length 30 mm | In distribution |
| B-AI-0615 | Length 15 mm | In distribution |
| B-AI-0824 | Length 24 mm | In distribution |
| B-AI-1028 | Width 10 mm | In distribution |
| B-AI-0515 | Length 15 mm | In distribution |
| B-AI-0724 | Length 24 mm | In distribution |
| B-AI-0833 | Width 8 mm | In distribution |
| B-AI-0933 | Length 33 mm | In distribution |
| B-AI-0510 | Width 5 mm | In distribution |
| B-AI-0820 | Width 8 mm | In distribution |
| B-AI-0510 | Width 5 mm | In distribution |
| B-AI-0830 | Length 30 mm | In distribution |
| B-AI-0833 | Width 8 mm | In distribution |
| B-AI-0930 | Width 9 mm | In distribution |
| B-AI-1033 | Width 10 mm | In distribution |
| B-AI-0726 | Width 7 mm | In distribution |
| B-AI-0520 | Width 5 mm | In distribution |
| B-AI-0824 | Length 24 mm | In distribution |
| B-AI-0626 | Length 26 mm | In distribution |
| B-AI-0928 | Width 9 mm | In distribution |
| B-AI-0410 | Width 4 mm | In distribution |
| B-AI-0520 | Width 5 mm | In distribution |
| B-AI-0726 | Width 7 mm | In distribution |
| B-AI-1030 | Length 30 mm | In distribution |
| B-AI-0830 | Length 30 mm | In distribution |
| B-AI-1033 | Width 10 mm | In distribution |
| B-AI-0620 | Width 6 mm | In distribution |
| B-AI-0828 | Width 8 mm | In distribution |
| B-AI-0620 | Width 6 mm | In distribution |
| B-AI-1030 | Length 30 mm | In distribution |
| B-AI-0615 | Length 15 mm | 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 |
| 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 |
| Twist AP Suture Anchors | Parcus Medical, LLC | 17 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130716 | 2013-08-28 |
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.