Who else makes this device?

Name: SuperBall 24 degrees Up
Brand: SuperBall 24 degrees Up

General & Plastic Surgery › TherapeuticSuture, Nonabsorbable, Synthetic, Polyethylene

SuperBall 24 Degrees Up

The SuperBall™ Meniscal Repair System 24 Up is a single-patient and single-use device for repair procedures in the lateral and medial meniscus and for meniscal implant fixation. The…

Registry build 21.09.26

The SuperBall™ Meniscal Repair System 24 Up 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.

6manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shanghai (2), Shandong (2), Fujian (1).

Chinese manufacturers registered for FDA product code GAT
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

Regulatory record for SuperBall 24 degrees Up
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
Record published	2025-06-30
Record revised	2026-04-13 (version 2)

Specifications

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 numbers for SuperBall 24 degrees Up
Catalogue number	Size	Status
A		In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

FDA premarket approvals naming this product code
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.