SuperBall 12 Degrees Reverse
The SuperBall 12° Reverse Meniscal Repair System is an all-inside suture retention device for meniscal repair. It is used for percutaneous or endoscopic soft tissue procedures, including…
The SuperBall 12° Reverse Meniscal Repair System is an all-inside suture retention device for meniscal repair. It is used for percutaneous or endoscopic soft tissue procedures, including repair of the lateral and medial meniscus within the outer two-thirds of the meniscal zone.
Two nonabsorbable soft suture implants and a one-way self-locking securing element are preloaded in a curved needle delivery system. The implants and sutures contain polyester and ultra-high molecular weight polyethylene. The device delivers the implants sequentially to secure the repair.
Listed Item
The SuperBall™ Meniscal Repair System 12 Reverse is a single-patient and single-use device for repair procedures in the lateral and medial meniscus and for meniscal implant fixation. The SuperBall™ System is provided EtO sterile.
Depth Control and Supply
The delivery system has an integrated depth limiter adjustable from 10 to 18 mm between the limiter and needle tip. The system is supplied ethylene oxide sterile for single-patient, single use.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| 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 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Arcuro Medical Ltd., Israel |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Manufacturer |
| 510(k) | K223500 |
| Record published | 2025-06-30 |
| Record revised | 2026-04-13 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223500 | 2023-08-10 |
| K180191 | 2018-06-05 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | Davis & Geck, Inc. |
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.