Bone cement, β-TCP graft substitute, PEEK and all-suture anchors, polymer ligating clips — made in our own plants since 1990, shipped to 80+ countries, with the CE and ISO 13485 files your registration needs already on the shelf.
Medical Fair Asia draws over 13,700 attendees from 60 countries, and more than 40% travel in — largely from Malaysia, Indonesia, Thailand, the Philippines and Vietnam. If you are building an orthopaedic or general-surgery portfolio for one of those markets, three things usually decide it.
Two PMMA cements, a 100% β-TCP graft substitute, a four-anchor rotator-cuff system and a polymer ligating clip line. One contract, one shipment, one set of payment terms — instead of four vendors and four sets of lead times.
CE marking, ISO 13485:2016 and KGMP certification, plus Free Sale Certificates and Certificates of Origin. That is the evidence pack HSA, MDA, Kemenkes and Thai FDA all start from — so your filing begins on day one, not month three.
Our own facilities in Korea, China and Vietnam — including in-house UHMWPE suture and PMMA production. That is what makes OEM, private label, custom packaging and territory-specific configurations a real conversation rather than a polite no.
Every specification below is from our current product documentation. Full IFUs, brochures and test reports are available at the booth or on request.
PMMA BONE CEMENT · VERTEBROPLASTY & KYPHOPLASTY
PMMA bone cement for vertebral augmentation, formulated with 60% zirconium dioxide as radiopacifier. Supplied as a powder and liquid set.
| Order no. | BG001 |
|---|---|
| Components | Powder 20 g · Liquid 8.5 g |
| Radiopacifier | Zirconium dioxide, 60% |
| Presentation | Powder / liquid, hand mixed |
| Marking | CE |
ANTIBIOTIC PMMA BONE CEMENT · GENTAMICIN
PMMA bone cement for arthroplasty, containing 4.22% gentamicin sulfate in the powder. Violet pigment in the liquid component. Sets in eight minutes at 21 °C.
| Antibiotic | Gentamicin sulfate 4.22%, in powder |
|---|---|
| Setting time | 8 min @ 21 °C |
| Pigment | Violet, in liquid |
| Indications | Hip · TKA · hybrid & uni knee · elbow · shoulder stem · glenoid |
100% BETA-TRICALCIUM PHOSPHATE BONE GRAFT SUBSTITUTE
Synthetic osteoconductive bone graft substitute, 100% beta-tricalcium phosphate. Supplied as wedges, cylinders, taper cylinders, chips and granules.
| Material | 100% synthetic β-TCP |
|---|---|
| Porosity | 50 – 70% (granule and block forms) |
| Macropores | 100 – 450 µm |
| Micropores | < 10 µm |
| Compressive strength | 3 – 5 MPa |
| Wedge sizes | 7 / 10 / 13 mm × 35 mm and × 45 mm |
| Cylinder sizes | Ø11 / 16 / 25 mm × 10 / 20 / 30 mm |
| Forms | Wedge · cylinder · taper cylinder · chip · granule |
METAFIX PK · METAFIX KNOTLESS PK · METALOCK KNOTLESS PK · AUTOKNOT
A complete suture-bridge construct from one box: a PEEK-OPTIMA medial-row anchor, two tap-in knotless lateral-row anchors, and a ball-shaped all-suture anchor for minimal bone removal. All loaded with #2 UHMWPE.
| MetaFix PK | Medial row, knotted · PEEK-OPTIMA · Ø4.5 / 5.5 mm · 7-rev double thread |
|---|---|
| MetaFix Knotless PK | Lateral row, tap-in · Ø4.5 / 5.5 mm · inner-screw fixation, torque limiter |
| MetaLock Knotless PK | Lateral row, tap-in · Ø4.75 / 5.5 mm · wide eyelet, 6 sutures at once (max 8) |
| AutoKnot | All-suture, ball type · Ø1.8 / 2.8 mm · single or double loaded |
| Hole depth | 22.5 mm (PEEK) · 18 / 26 mm (all-suture) |
| Suture | UHMWPE, #2 and #0, colour-coded |
| Instruments | 3.8 mm awl · 4.5 / 5.5 mm awl dilators · reusable drill guides |
POLYMER LIGATING CLIPS · OPEN AND LAPAROSCOPIC
Non-absorbable polyoxymethylene ligating clips with a patented circular projection inside the jaw, a flexible hinge and a locking mechanism. Four sizes, with matching reusable stainless appliers.
| Size M | 2 – 7 mm · REF PCMM01A |
|---|---|
| Size ML | 3 – 10 mm · REF PCML02A |
| Size L | 5 – 13 mm · REF PCLL03A |
| Size XL | 7 – 16 mm · REF PCXL04A |
| Packing | 6 clips / cartridge · 14 cartridges / box · 84 clips / box |
| Material | Polyoxymethylene, non-absorbable |
| Appliers | Stainless, non-detachable · premium 210 mm · standard 280 mm |
| Sterilisation | Pre-vacuum 132 °C / 4 min · 134 °C / 3 min |
| Marking | CE |
SINGLE-PORT ACCESS DEVICE, FILTER & WOUND RETRACTOR
Single-incision laparoscopic access device with a transparent window, a locking plate mechanism and a filter component, supplied with a wound retractor.
| Use | Single-incision laparoscopic surgery |
|---|---|
| Window | Clear and transparent, direct field view |
| Filter | Replaceable filter component |
| Attachment | Locking plate, tool-free attach / detach |
| Marking | CE |
We would rather answer them now, so the booth conversation can be about your territory instead of our paperwork.
Yes, by territory and by product family, against an agreed annual volume and a registration timeline. Terms are set case by case — bring your volume forecast.
There is no fixed minimum per item — you can mix SKUs to reach a minimum order value, so cements, clips and anchors travel in the same shipment. Your first market-seeding order is treated separately: tell us what your surgeons need to evaluate and we will work to that, not to a container.
Yes. We manufacture in our own plants, so your brand, your packaging and your carton artwork are all on the table. This is a large share of our existing export business.
CE certificate, ISO 13485:2016, KGMP, Declaration of Conformity, Free Sale Certificate, Certificate of Origin and IFUs. Summary technical documentation on request under NDA. Legalisation supported where required.
4 – 5 weeks from order as standard. Cements and β-TCP are produced to stock; anchor and instrument sets are built to order, which is where the upper end of that range comes from.
Product training for your sales team, surgeon workshop support, marketing artwork in editable format, and direct access to our RA team during your filing.
One thing worth knowing before you file: in Singapore the registrant owns the registration, and moving it to another distributor later is a paid Change of Registrant application with its own waiting period. Worth agreeing who holds it before anyone submits anything.
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