(82 days)
The Bio-Modular Shoulder System is intended for partial or total shoulder ioint arthroplasty. Total shoulder replacement devices are intended to be inserted with bone cement. Non-porous coated humeral stems being implanted for hemi-arthroplasty may be press fit.
Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Treatment of acute fracture of the humeral head unmanageable using other treatment methods
- Cuff tear arthroplasty
The Bio-Modular Shoulder System consists of humeral stems of various lengths and porous coating levels, humeral heads of various diameters and neck lengths, and both all polyethylene and metal backed polyethylene glenoid components. Each type of component will be described individually.
Humeral Stems: The Bio-Modular Humeral stem features a bi-planer taper to promote stress transfer down the length of the stem. This minimizes removal of endosteal bone and enhances the ease of stem insertion. Each stem has a lateral fin to provide rotational stability. Holes in the fin provide the surgeon with the option of suture attachment during fracture reconstruction. A collar minimizes subsidence. Stems are available in a primary lenath of 115mm in 1mm incremental stem diameters from 6 to 17mm. Longer stems (190mm) are available in 2mm incremental diameters from 7 to 13mm.
Humeral stems are available in either an Interlok (grit blasted) finish or with plasma spray porous coating. Porous stems are circumferentially porous coated proximally to enhance cement fixation. Centering sleeves are available to assist in stem alignment during cementina.
Humeral Heads: All humeral stems feature a reverse Morse taper for attachment of the modular humeral head. This means that instead of the tapered post being on the humeral stem like traditional devices, the post is on the modular head and the bore is in the stem. The advantage of the reverse taper configuration is that it allows for maximum exposure of the glenoid when the stem is in place. Therefore, the humeral stem may be implanted prior to glenoid resurfacing. Humeral heads are available in a variety of diameters and neck lengths. In addition to the standard symmetrical bearing surface, heads are available with articular extensions to enhance component stability.
Glenoid Components: Although the humeral stem and head may be implanted as a hemishoulder replacement, glenoid components are available for total shoulder replacement. All polyethylene alenoid components come in two styles. The keeled component features a triangular keel that may be trimmed for better fit during surgery. This style is available in 3 sizes and 2 thicknesses. The second style features 3 pegs to assist in fixation and is available in 3 sizes and 1 thickness. Both styles have an embedded x-ray marker.
A modular, porous coated, metal backed glenoid component provides distribution of stresses into the cement. The device features a central tapered peq and the option of screw fixation.
I am sorry, but the provided text from the K992119 document does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.
The document is a 510(k) premarket notification for the Bio-Modular Shoulder System, focusing on:
- Device Description: Details on humeral stems, heads, and glenoid components.
- Intended Use and Indications for Use: What the device is meant to treat.
- Substantial Equivalence: Comparing the device to other legally marketed predicate devices.
- FDA Decision: Granting substantial equivalence and allowing market entry.
This type of document typically focuses on demonstrating equivalence to existing devices rather than presenting the results of a standalone study against specific, novel acceptance criteria defined by the manufacturer. Therefore, I cannot extract the requested information from the provided text.
§ 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.”