Summary for ARTG Entry:
Smith & Nephew Pty Ltd - Prosthesis, internal, ligament, anchor
ARTG entry for
Medical Device Included Class IIb
Smith & Nephew Pty Ltd
PO Box 393, North Ryde, NSW, 1670
ARTG Start Date
Medical Device Class IIb
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
7000 West William Cannon Drive
Austin, TX, 78735-8531
United States Of America
1. Prosthesis, internal, ligament, anchor
Single Device Product
36174 Ligament anchor
The device is intended to be used for soft tissue to bone fixation for:
Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral
reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis
Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus
reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair
Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon
Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and
posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus
advancement (VMO); joint capsule closure
Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in
phalanx; Volar plate reconstruction
Hip: Acetabular labral repair
No Specific Conditions included on Record
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