Who else makes this device?

Name: Speedbutton
Brand: Speedbutton

Orthopedic › ProstheticFastener, Fixation, Nondegradable, Soft Tissue

Speedbutton

The SPEEDBUTTON™ Suture Anchor is intended to be used for suture or tissue fixation in the foot and ankle. Specific indications are listed below: Foot/Ankle: Lateral Stabilization, Medial…

Registry build 21.09.26

The SPEEDBUTTON™ Suture Anchor is intended to be used for suture or tissue fixation in the foot and ankle. Specific indications are listed below: Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction

7manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MBI
Manufacturer	City	Province	Registered as	Device types
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Suzhou Kangli Orthopaedics Instrument Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	11
Renolit Hansen Packaging Tech. (BJ) Ltd.	Beijing	Beijing	Contract manufacturer	1
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38
Suzhou Endophix Co., Ltd.	Suzhou	Jiangsu	Manufacturer	17
Zhejiang Decans Medical Devices Co., Ltd.	Jiaxing	Zhejiang	Manufacturer	10

Record

Regulatory record for Speedbutton
Listed by	Crossroads Extremity Systems LLC, United States
FDA product code	MBI
Device type	Fastener, Fixation, Nondegradable, Soft Tissue
Device class	Class 2
Regulation	21 CFR 888.3040
Establishment	Complaint-file establishment, Manufacturer
510(k)	K153585
Record published	2021-01-22
Record revised	2025-05-30 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Speedbutton
Catalogue number	Size	Status
SpeedButton Kit 1x4mm		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Arthrex®	Arthrex, Inc.	362
HNM Sports Medicine	HNM Stainless, LLC.	150
Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors	GM DOS Reis Industria E Comercio Ltda	78
Juggerknot®	Biomet Orthopedics	77
Fastener, Fixation, Nondegradable, Soft Tissue	Parcus Medical, LLC	74
endophix	Suzhou Endophix Co., Ltd.	71
Titan	Medline Industries, Inc.	68
TopLock	Fusion Orthopedics, LLC	67
HNM Medical	HNM Stainless, LLC.	59
Orthobutton CL	Riverpoint Medical LLC	55
Apollo	Medline Industries, Inc.	53
JuggerKnot Soft Anchor	Riverpoint Medical LLC	46

Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K220797	2022-04-15
K160118	2016-05-03

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.