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Tota Hip Arthroplasty System
Overview

The MALUCTM Total Hip Arthroplasty System (THA) is used for primary total hip replacement in skeletally mature individuals. 

The system consists of monolithic cemented and press-fit femoral stems, modular CoCr and BIOLOX® delta femoral heads in various sizes and offsets, uncemented acetabular shells and conventional polyethylene liners. 

Accessory components include distal centralizers, cancellous bone screws and cement restrictors. Instrumentation necessary for proper implantation is also included.

Features
The MALUCTM Total Hip Arthroplasty System (THA) is available in a wide range of sizes, offering uncompromising intraoperative flexibility and full interchangeability of femoral, tibial and patellar components. Some notable design features include:
Features
  • Bipolar System For Hemiarthroplasty
  • ACETABULAR LINER
  • ACETABULAR SHELL
  • FEMORAL HEADS - CoCr
  • FEMORAL HEADS - Ceramic
  • MALUC STEM TPS/HA COATED
  • Flexible Matching

    MALUC Bipolar System List

    Bipolar Shell Spec.: 38-58 in 2 inc
    Bipolar Liner Assembly Spec.: 38/22, 40/22, 42/22, 44/28, 46/28, 48/28, 50/28, 52/28, 54/28, 56/28, 58/28
    Metal Femoral Head Spec.: 22M 22L
    ACETABULAR LINER

    1. Available in both conventional and highly cross-linked polyethylene (PE) (XLPE not cleared by FDA yet).
    2. Snap fit feature saves time in OR.
    3. Locking groove fracture enhances stability and minimizes potential for rotation metal and ceramic femoral heads.
    ACETABULAR SHELL

    1. Hemispherical in shape with an exterior of Titanium alloy material.
    2. Cluster hole design for the insertion of acetabular screws.
    3. Coatings available both in HA and TPS to enhance bony impaction.
    4. Scallop design to minimize potential for liner rotation.
    CoCr Femoral Heads
    1. Designed to enhance hip stability and minimize dislocation.
    2. Larger configuration heads with 12/14 taper to maximize range of motion.
    3. Multiple offset options to optimize anatomical fit.
    BIOLOX Delta-Ceramic Heads
    1. Increased Fracture Strength.
    2. Excellent Wear Properties.
    3. Unlimited Biocompatibility.
    1. Dual taper design increases rotational stability.
    2. Reduced neck geometry optimizes range of motion and reduces potential for femoral fracturing.
    3. Coatings available in both Titanium Plasma Spray (TPS) & Hydroxyapatite (HA) to enhance mechanical engagement in bone.
    4. Compatible with both metal and ceramic femoral heads. 
    1. In the selection of high-crosslinked polyethylene acetabular lining for the same acetabular cup, ball heads of different diameters can be selected for combination by adjusting the acetabular lining to meet different needs of doctors and patients.
    2. Various articular surface combinations meet different clinical needs.


Materials of Components:

Metal Femoral Head: Config Drawing No: SW-00006-14 Material = CoCrMo (casted)
Ceramic Femoral Head: Config Drawing No: SW-00006-32 Material = Ceramic
Titanium Femoral Stem (Ti Plasma): Config Drawing No: SW-00006-01 Material = Ti-6Al-4V ELI ASTM F136 (forgedTi Plasma
Titanium Femoral Stem (HA Coating): Config Drawing No: SW-00006-33 Material = Ti-6Al-4V ELI ASTM F136 (forgedHA Coating
Polished Femoral Stem: Config Drawing No: SW-00006-15 Material = CoCrMo (casted)
Polished Femoral Stem LONG: Config Drawing No: SW-00006-28 Material = CoCrMo (casted)
Distal Cement Plug: PMMA  Centralizer: PMMA
Acetabular Cup (Ti Plasma): Config Drawing No: SW-00006-27 Material = Ti-6Al-4V ELI ASTM F136 (forged) Ti Plasma
Acetabular Cup (HA Coating): Config Drawing No: SW-00006-34 Material = Ti-6Al-4V ELI ASTM F136 (forgedHA Coating
CVT-UHMWPE ACETABULAR LINER: Config Drawing No: SW-00006-26 Material = Conventional UHMWPE
Fastening Screw: Ti-6Al-4V ELI ASTM F136
Instruments
System Components
Thoughtful, surgeon-friendly design and modular, space-saving trays help reduce patients' time under anesthesia by making instrument identification and access quick and easy. The design also reduces space needed in the OR and facilitates efficient, effective in-hospital instrument processing. Essential components of the The MALUCTM Total Hip Arthroplasty System Instrument Set include:
Instruments
  • A Full Set of Tools Layer II
  • A Full Set of Tools Layer I
    16. Biological stalk medullary cavity file 17. Biological handle intramedullary knife 18. Acetabular file power link 19. Acetabulum file 20. Cup holder 21. Probe 22. Bit Guide 23.Soft Drill Connector 24. Universal screwdriver 25. Nail-holding forceps 26. Mortar lining installer 27. Medullary cavity file with smooth bone cement handle 28. Cement handle distal reamer 29. Distal plug installer 30. Cement handle installer
    1. Osteotomy indicator plate 2. Femoral head extractor 3. Medullary opener 4. Grooved hammer 5. Connecting handle 6. Scraper spoon 7. Connector of medullary file 8. Handle mounter 9. Test head 10. Test head 11. Quick Change Handle 12. Test cup 13. Test cup connecting handle 14. Handle penetrator 15. Biological stalk medullary cavity file
Indication


The SurgTech MALUCTM System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.



(1) patients with old femoral neck fracture, femoral head or acetabular damage and pain, which affects joint function.

(2) patients with avascular necrosis of the femoral head, collapse and deformation of the femoral head and destruction of the acetabulum
(3) patients with osteoarthritis, acetabular changes, pain and dysfunction
(4) patients with rheumatoid arthritis, ankylosing spondylitis, joint pain, deformity, limited movement.
(5) degenerative osteoarthritis: it is more common in the elderly over 50 ~ 60 years old, with acetabular damage and femoral head deformation.
(6) low-grade malignant tumors located in the neck of the femoral head or acetabulum.
(7) acetabular dysplasia, chronic hip dislocation, congenital hip dislocation, and trauma-induced hip dislocation.

Contraindication

1. Patients with various acute inflammatory lesions or hip infection foci
2. Hip neuropathy
3. Lack of hip muscle strength
4. Patients with immature bone development
5. Patients with diseases of vital organs that have not been effectively controlled
6. Patients who are difficult to cooperate with treatment
7. Pathological obesity
8. Patients with severe vascular disease of the lower extremities

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