Overview
The INTEOS® Distal Radius System M4 is Hofer Medical Solutions' current distal radius plate-and-screw system, which Hofer describes as multidirectional and angle-stable, built on the internal fixator principle. It is indicated for malposition or instability of a distal radius fracture at the typical site, with or without joint involvement, and for corrective osteotomy close to the joint for post-fracture malposition. The palmar plates use a standard flexor-side approach.
The M4 palmar plates are low-profile and made of titanium. The standard, narrow, wide and multihole plates are 2.0 mm thick, with four head widths from 21 mm (narrow) to 28 mm (wide), and take up to nine polyaxial, angular-stable epiphyseal screws. They use Ø 2.5 mm INTEOS® locking and standard screws with a ForceDRIVE T6 drive. Features include an oblong hole for primary variable fixation, a reduction window, a third screw row, direct styloid fixation and K-wire holes up to 1.2 mm. The shape-left (SL) and shape-right (SR) plates can each be used on either radius.
Hofer states that its INTEOS®Lock locking system gives angular variability of up to 70° with full angular stability. Hofer's instructions for use add that angular-stable locking is weaker with the screw angled than on axis. The system also includes XXL, watershed, Y, PI, osteotomy, rim, lunate facet and revision palmar plates, dorsal plates and a distal ulna plate. It is part of the Hofer Osteosynthesis range, used in internal osteosynthesis of the distal radius.
OrganoGEN is the exclusive distributor of the Hofer Medical Solutions INTEOS® distal radius system in Cyprus. The standard, narrow, wide and XXL M4 palmar plates are GESY-covered for distal radius fracture fixation. Other plates are confirmed case by case with OrganoGEN.
Indications & Contraindications
Indicated For
- Malposition or instability of a distal radius fracture at the typical site (loco typico), with or without joint involvement
- Corrective osteotomy close to the joint for malposition after a wrist fracture or after fracture healing
- Distal ulna plate: malposition or instability of a distal ulna fracture without joint involvement (23-A1 fracture), and corrective osteotomy close to the joint after fracture or fracture healing
Contraindicated For
- Absolute: known or suspected sensitivity to the implant material
- Absolute: application on the spine
- Absolute: a mainly ulnar-dorsal, displaced articular fragment that cannot be adequately reduced and fixed from the flexor side (Barton fracture, AO B2)
- Absolute: open wrist fracture grade 2 or 3 with wound contamination, without adequate intra-operative cleansing or soft-tissue cover
- Relative: acute, chronic or local infection or inflammation, reduced blood flow to the area, reduced bone stability for secure implant fixation, or inadequate soft-tissue cover
- Relative: open epiphyseal plates, obesity, or limited patient compliance with post-operative rehabilitation
Technical Specifications
| Manufacturer | Hofer GmbH & Co KG (Hofer Medical Solutions), Fürstenfeld, Austria |
|---|---|
| Distributor in Cyprus | OrganoGEN Limited (exclusive) |
| Plate families | Palmar (standard, narrow, wide, multihole, XXL, watershed, Y, PI, osteotomy, rim, lunate facet, revision), dorsal, distal ulna |
| Implant material | Titanium |
| Palmar head widths | Narrow 21 mm, standard 24.5 mm, multihole 26 mm, wide 28 mm |
| Plate thickness | 2.0 mm (standard, narrow, wide, multihole, watershed). XXL 3.2 mm. Revision 2.5 mm |
| Head screws | Up to 9 polyaxial, angular-stable epiphyseal screws |
| Screws (M4 palmar plates) | INTEOS® 2.5 locking screws 6 to 44 mm and standard screws 6 to 32 mm, in 2 mm steps, Ø 2.5 mm, self-tapping |
| Drill | Ø 2.0 mm standard. Ø 1.8 mm for poor bone quality |
| Drive | ForceDRIVE T6 |
| Locking system | INTEOS®Lock (Hofer: up to 70° with full angular stability) |
| Regulatory | CE-marked Class IIb under EU MDR 2017/745 (notified body 0483) for plates and screws. Instruments Class I or IIa |
| GESY status in Cyprus | Covered for distal radius fracture fixation with the standard, narrow, wide and XXL M4 palmar plates. Other plates case by case |
GESY Coverage & Pricing in Cyprus
The standard, narrow, wide and XXL M4 palmar plates are GESY-covered for distal radius fracture fixation. When they are implanted by a participating surgeon at a GESY-contracted hospital, the cost of the implants is included in the hospital reimbursement; patients are not billed separately. Other plates are confirmed case by case with OrganoGEN.
For self-pay or international patients, OrganoGEN provides hospital quotations on request. Request a quote.
Frequently asked questions
What is the INTEOS® Distal Radius System M4 indicated for?
Which plates does the INTEOS® Distal Radius System M4 include?
How does the INTEOS®Lock locking system work?
Is the INTEOS® Distal Radius System M4 CE-marked?
Is the INTEOS® Distal Radius System M4 covered by GESY in Cyprus?
Who manufactures the INTEOS® Distal Radius System M4?
How does the INTEOS® Distal Radius System M4 relate to the Hofer Osteosynthesis range?
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