(112 days)
The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend 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 Ascend 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
All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.
The Ascend Shoulder System consists of a humeral stem, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.
The present device submission corresponds to changes made to the version of the device cleared in 510(k) K071147.
The provided text describes a Special 510(k) Premarket Notification for the Tornier Inc. Ascend Shoulder System, which is a medical device. This type of submission is for modifications to a previously cleared device and focuses on establishing substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria through clinical studies.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document. The document focuses on regulatory classification, device description, indications for use, and a summary of non-clinical testing to demonstrate substantial equivalence to a predicate device (Tornier Nexa Orthopedics Total Shoulder System, K071147).
The non-clinical testing performed includes:
- Taper disassembly strength
- Mismatch evaluation
- Extraction testing
- Cadaveric evaluation
The document explicitly states: "The results of these non-clinical tests allow us to conclude that the Ascend Shoulder System described in this submission is substantially equivalent and as safe and effective as the original device." This indicates that no separate study proving the device meets specific acceptance criteria as defined by performance metrics (like sensitivity, specificity, accuracy, etc.) was conducted or reported in this submission format, as it's not typically required for a Special 510(k) for a modified Class II orthopedic implant.
§ 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.”