Manufacturing Capabilities

3 Manufacturing Sites To Serve You Better

Mfg A
StraitsOrtho No. 1 Manufacturing Site at Prai, Penang
Mfg B
StraitsOrtho No. 2 Manufacturing Site at Penang Science Park, Penang
100K Cleanroom
StraitsOrtho No. 3 Cleaning & Packaging Site at Teluk Kumbar, Penang

Professional & Qualified Skilled Resources

StraitsOrtho employs more than 650 highly trained and skilled personnel.

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Straits’ Offerings

Straits has for more than a decade served legal manufacturers of orthopaedics devices from the Mature Markets and the Emerging Markets without any product recall with these capabilities:

      • Machining, including 5 axis milling, 10 axis Swiss turning, 6 axis CNC grinding, 4 axis wire EDM and 3 axis spark EDM
      • Welding (TIG, Plasma and Laser)
      • Surface treatment, including heat treat, electropolishing, titanium color anodizing, biocompatible low friction hard chroming and passivation
      • Labeling, including laser marking
      • Non Sterile and Sterile packaging and sterilization
      • Dock to stock
      • Production and kitting of instruments in a set and delivering to customer locations worldwide
      • Inspection (Dimensional, hardness, surface finish, functional and positioning)
Heat Treatment & Stress Relieving
Heat Treatment & Stress Relieving
Surface Treatment
Surface Treatment
TIG/Plasma/Laser Welding
TIG/Plasma/Laser Welding
CNC Milling
CNC Milling

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Advanced Technology & Equipment

Straits has invested in a comprehensive range of technology and equipment, including:

      • CNC mills
      • CNC Swiss turn
      • Wire and spark EDM
      • Various surface treatment
      • Laser marking (metal and polymers)
      • Ultrasonic cleaning and vapor degreasing
      • Passivation – citric and nitric
        100K Cleanroom for sterile packaging
      • OGP inspection
      • CMM – Brown & Sharpe PC-DMIS and Mitutoyo

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Straits’ Offerings

For more than a decade, Straits has and continues to contract manufacture the following main products for our customers at a component level, non-sterile packaged level, sterile packaged level, and Gamma sterilized, as the case may be:

      • Nails
      • Knee components for implant
      • Prep kit and cement products
      • Sutures
      • Pins and wires
      • Plates
      • Bone screws
      • External fixation devices
      • Complex instruments for hips, knees and nails including cutting blocks and broaches
      • Knee instruments in a set
      • Nail instruments in a set including target guides
      • Spine instruments
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Manufacturing site accepted in more than 100 importing countries:

Regulatory & Compliance Standards

      • StraitsOrtho is certified to EN ISO 13485:2016
      • StraitsOrtho is certified to ISO 9001:2015
      • StraitsOrtho is registered with the US FDA
        StraitsOrtho was inspected by the US FDA in 2019
      • StraitsOrtho has received a Confirmation Letter for JGMP Audit 30 July, 2019
gmp_image1
FDA
ISO 13485
ISO_9001-2015

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Straits Orthopaedics (Mfg) Sdn Bhd

2483, Tingkat Perusahaan 4A, Prai Free Industrial Zone

13600 Prai, Penang, Malaysia

Contact Us

Phone: +604-3838187

Email: [email protected]