(112 days)
IN ANATOMIC:
The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The AEQUALIS FLEX REVIVE Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints disabled by:
- Rheumatoid arthritis with pain
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- · Correction of functional deformity
- · Fractures of the humeral head
- · Traumatic arthritis
- · Revision of other devices if sufficient bone stock remains
IN REVERSE:
The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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
- · Traumatic arthritis
- · Massive and non-repairable rotator cuff tear
- · Revision of the devices if sufficient bone stock remains
The reversed tray and polyethylene insert are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.
Notes:
- 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 intents 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.
AEQUALIS FLEX REVIVE Shoulder System (AFR) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. AFR includes a proximal body (metaphysis), spacer(s), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts.
The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Ascend Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery.
The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 180 mm (using the standard proximal body, spacers, and stem) in 10mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.
The proximal body, stem, and spacers are made from Ti6Al4V per ASTM F-136. The proximal body and stem have a Titanium plasma coating. The assembly screw and locking cap are made from of CoCr per ISO 5832-121. They are single use and packaged sterile, using gamma radiation at a minimum dose of 25 KGy to an SAL of 1x10-6.
The provided text describes the AEQUALIS FLEX REVIVE Shoulder System, a medical device, and summarizes the non-clinical performance testing conducted to support its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance and Conclusion |
|---|---|---|
| Fatigue Testing | The humeral stems were tested to 10 million cycles (5 million in each configuration) without failure, fracture, or dislocation when inspected after each tested configuration at a magnification of 50X. | Met acceptance criteria. Tested without failure, fracture, or dislocation. |
| Range of Motion | The Aequalis Flex Revive Shoulder System met the range of motion requirements in ASTM F1378-12. | Met acceptance criteria. |
| Taper Tensile | Taper resultant force were not significantly lower than those of the Ascend Flex taper connections when analyzed with a 2-sample T-test. | Met acceptance criteria. Taper resultant force was not significantly lower than predicate. |
| Tensile Static Torque | The disassociation torque of the male taper from the female taper was not statistically lower than 1.72Nm, or two times the anticipated frictional torque between glenoid sphere and the reversed insert. | Met acceptance criteria. Disassociation torque was not statistically lower than specified value. |
| Press Fit Preparation | The AFR Shoulder System achieved a press-fit for the proximal body and distal stem allowing the implant to attain proper seating and acceptable fixation. | Met acceptance criteria. Achieved proper seating and acceptable fixation. |
| Cemented Preparation | The AFR Humeral Stem cement mantle thickness met or exceeded the Ascend Flex cement mantle thickness. | Met acceptance criteria. Cement mantle thickness met or exceeded predicate. |
| Biocompatibility | Biocompatibility requirements per ISO 10993-1 were met. | Met acceptance criteria. |
| Endotoxin | Endotoxin results per ST72 demonstrated |
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”