SF Push-in Anchor 1.6
The SF Push-in Anchor 1.6 fixes soft tissue to bone using suture in specified hand, wrist, elbow, shoulder, foot, ankle and knee repairs. It is a fully bioresorbable polymer implant. The…
The SF Push-in Anchor 1.6 fixes soft tissue to bone using suture in specified hand, wrist, elbow, shoulder, foot, ankle and knee repairs. It is a fully bioresorbable polymer implant. The 1.6 mm anchor is designed to be inserted only with the SupraFuser ultrasonic generator.
A sonotrode attached to the handpiece transmits ultrasonic vibration to the anchor in a predrilled hole. Energy liquefies polymer at the bone interface, allowing it to flow into spaces within the surrounding cancellous bone. The polymer then solidifies to anchor the implant.
Anchor and Suture
The implant is made of poly-L-lactide-co-D,L-lactide and is supplied sterile. The 1.6 mm configuration is 5.2 mm long and accepts sutures from USP 4-0 to 0. Suture fixation uses manual knotting.
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 | Surgical Fusion Technologies GmbH, Switzerland |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K240288 |
| Record published | 2024-04-12 |
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 | Special storage condition: max.43.3 Celcius |
| Sizes | Width 1.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SF Push-in Anchor 1.6 | Width 1.6 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 |
| 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 |
|---|---|
| K260294 | 2026-03-27 |
| K240288 | 2024-04-01 |
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.