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510(k) Data Aggregation
(150 days)
In Anatomic:
Tornier HRS Max humeral assembly can be used for anatomic arthroplasty when used with a humeral head. It can be used as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total replacement.
Tornier HRS Max is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with an intact or reconstructable rotator cuff with pain disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (i.e., osteoarthritis and avascular necrosis)
- Fractures of the humeral head
- Post-Traumatic arthritis
- Oncology applications including bone loss due to tumor resection
- Significant humeral resection where adequate fixation can be achieved
In Reverse:
Tornier HRS Max is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the humeral head
- Post-Traumatic arthritis
- Massive and non-repairable rotator cuff tear
- Oncology applications including bone loss due to tumor resection.
- Significant humeral resection where adequate fixation can be achieved
The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of a well-fixed humeral assembly during revision surgery for patients with a functional deltoid muscle.
Notice:
- All components are single-use.
- The coated humeral stem is intended for cemented or cementless use
- The all-poly glenoid components are intended for cemented use only.
- The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
- Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
The HRS Max System is designed to address massive proximal humeral bone loss and provide for deltoid wrapping. The modular functionality of the HRS Max Shoulder System allows clinicians to create constructs that can address unique anatomies which include proximal humeral bone loss, while also allowing for use in anatomic hemiarthroplasty or reversed configuration.
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