Orthopedic › ProstheticScrew, Fixation, Bone

SI-LOK

The SI-LOK screw is an implant for sacroiliac joint fusion in conditions including joint disruption and degenerative sacroiliitis. It belongs to a fixation system designed around cannulated…

Registry build 21.09.26

The SI-LOK screw is an implant for sacroiliac joint fusion in conditions including joint disruption and degenerative sacroiliitis. It belongs to a fixation system designed around cannulated screws with preassembled contouring washers.

The screws and washers are made from titanium alloy. The family includes partially and fully threaded configurations, different diameters and lengths, and options with or without hydroxyapatite coating.

Listed Item

SI-LOK 10.0mm HA Lag Screw, SL, 55mm

Fixation Arrangement

The contouring washer is assembled onto the screw before use. Additional screws may provide supplemental fixation as required within the system. The screw implant supplies the fixation element across the treated sacroiliac region.

31manufacturers in China registered for this device type
89catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWC
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11

Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone

Record

Regulatory record for SI-LOK
Listed by Globus Medical, Inc., United States
FDA product code HWC
Device type Screw, Fixation, Bone
Device class Class 2
Regulation 21 CFR 888.3040
Establishment Manufacturer, Exporter
510(k) K112028
Record published 2015-10-22
Record revised 2025-07-02 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date
Sizes Outer diameter 8 to 12 mm; length 25 to 60 mm

Catalogue Numbers

Catalogue numbers for SI-LOK
Catalogue number Size Status
139.314 Outer Diameter 11 mm In distribution
139.282 Length 30 mm In distribution
139.526S Length 50 mm In distribution
139.317 Length 55 mm In distribution
139.326 Length 50 mm In distribution
139.404 Length 40 mm In distribution
139.718S Length 60 mm In distribution
139.426 Outer Diameter 12 mm In distribution
139.722S Length 30 mm In distribution
139.388 Outer Diameter 8 mm In distribution
139.318 Outer Diameter 11 mm In distribution
139.325 Length 45 mm In distribution
139.115 Outer Diameter 11 mm In distribution
139.296 Length 50 mm In distribution
139.607S Length 55 mm In distribution
139.517S Outer Diameter 11 mm In distribution
139.126 Outer Diameter 12 mm In distribution
139.395 Length 45 mm In distribution
139.125 Length 45 mm In distribution
139.522S Length 30 mm In distribution
139.687S Outer Diameter 8 mm In distribution
139.502S Length 30 mm In distribution
139.207 Length 55 mm In distribution
139.506S Outer Diameter 10 mm In distribution
139.507S Outer Diameter 10 mm In distribution
139.785S Length 45 mm In distribution
139.414 Length 40 mm In distribution
139.217 Outer Diameter 11 mm In distribution
139.524S Outer Diameter 12 mm In distribution
139.625S Outer Diameter 12 mm In distribution
139.313 Length 35 mm In distribution
139.616S Outer Diameter 11 mm In distribution
139.825S Length 45 mm In distribution
139.618S Length 60 mm In distribution
139.516S Length 50 mm In distribution
139.685S Length 45 mm In distribution
139.688S Length 60 mm In distribution
139.416 Outer Diameter 11 mm In distribution
139.427 Outer Diameter 12 mm In distribution
139.815S Length 45 mm In distribution
139.205 Outer Diameter 10 mm In distribution
139.398 Length 60 mm In distribution
139.501S Length 25 mm In distribution
139.528S Outer Diameter 12 mm In distribution
139.287 Outer Diameter 8 mm In distribution
139.312 Outer Diameter 11 mm In distribution
139.788S Length 60 mm In distribution
139.515S Length 45 mm In distribution
139.692S Length 30 mm In distribution
139.327 Outer Diameter 12 mm In distribution
139.606S Length 50 mm In distribution
139.283 Length 35 mm In distribution
139.407 Outer Diameter 10 mm In distribution
139.226 Length 50 mm In distribution
139.323 Length 35 mm In distribution
139.284 Outer Diameter 8 mm In distribution
139.415 Outer Diameter 11 mm In distribution
139.307 Outer Diameter 10 mm In distribution
139.725S Outer Diameter 12 mm In distribution
139.724S Length 40 mm In distribution
139.127 Length 55 mm In distribution
139.303 Length 35 mm In distribution
139.827S Length 55 mm In distribution
139.206 Length 50 mm In distribution
139.698S Outer Diameter 9 mm In distribution
139.315 Length 45 mm In distribution
139.697S Outer Diameter 9 mm In distribution
139.807S Length 55 mm In distribution
139.285 Length 45 mm In distribution
139.728S Length 60 mm In distribution
139.121 Length 25 mm In distribution
139.117 Length 55 mm In distribution
139.808S Outer Diameter 10 mm In distribution
139.105 Outer Diameter 10 mm In distribution
139.797S Length 55 mm In distribution
139.304 Length 40 mm In distribution
139.298 Length 60 mm In distribution
139.322 Length 30 mm In distribution
139.101 Length 25 mm In distribution
139.627S Length 55 mm In distribution
139.805S Outer Diameter 10 mm In distribution
139.806S Length 50 mm In distribution
139.824S Length 40 mm In distribution
139.386 Length 50 mm In distribution
139.693S Outer Diameter 9 mm In distribution
139.385 Outer Diameter 8 mm In distribution
139.796S Length 50 mm In distribution
139.508S Outer Diameter 10 mm In distribution
139.608S Outer Diameter 10 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Screw, Fixation, Bone Synthes Gmbh 3,975
Aptus Medartis Inc. 3,623
Acumed Acumed LLC 3,187
Arthrex® Arthrex, Inc. 2,781
OsteoMed Osteomed 2,764
Screw, Fixation, Bone AAP Implantate AG 2,176
Screw, Fixation, Bone Zimmer, Inc. 1,993
Arix System Bone Screw Jeil Medical Corporation 1,875
Cannulated Screw System + Tyber Medical 1,814
Cannulated Compression Headless Screw Tyber Medical 1,621
Microware Bone Plates and Bone Screws Microware Precision Co., Ltd. 1,601
Anthem Globus Medical, Inc. 1,538

Showing 12 of 5,775. All products under Screw, Fixation, Bone

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K222409 2022-09-08
K162825 2017-05-01
K112028 2011-12-09

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer