(137 days)
The Humelock Reversed Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.
The humeral stem of the Humelock Reversed Cemented Shoulder Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prosthesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotation spoiler can be used with either the cementless or the cemented stems.
The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.
The Humelock Reversed Shoulder is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this design is inverted compared to a traditional total shoulder prosthesis. The reverse shoulder is designed so that the ball of the articulation is on the glenoid side and the mating cup fits into the humeral stem. The components of the system include a glenoid baseplate, standard and locking bone screws, optional baseplate post extensions, centered and eccentric glenospheres with and without central screws, humeral cups, cementless and cemented humeral stems, optional cortical bone screws, an optional humeral spacer, an optional anti-rotation spoiler and an optional taper adapter for use in hemi-shoulder replacement.
The Humelock glenoid baseplate has a round base with a central, cannulated post and four peripheral, threaded screw holes. The outer edges of the baseplate are tapered to lock with the glenosphere component.
The glenoid baseplate is used with 4.5mm standard or locking bone screws for added stability. The bone screws are available in lengths from 20 - 50mm in 5mm increments.
Optional post extensions are available to extend the central post of the baseplate and provide additional anchoring in cases with poor bone quality. The post extensions are available in 6mm and 10mm lengths. When used, the post extensions screw into the baseplate post.
The glenoid baseplate, standard and locking screws, and post extensions are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxyapatite coating.
The Humelock Reversed Glenosphere is available in 36 and 40 mm diameter sizes in centered and eccentric styles. The eccentric glenospheres are designed to be offset from the center of the glenoid baseplate. All glenospheres have a 10° tilt. Although not physically tilted, the curvature of the glenosphere extends 10° beyond the equator of a hemisphere. This additional articular surface lateralizes the center of rotation to help reduce the potential for scapular notching by the humeral cup. All glenospheres mate with the glenoid baseplate via a taper lock; the glenosphere incorporates a female taper while the edges of the baseplate form a male taper. The glenospheres are also available with an optional central, cannulated screw. This screw can be threaded through the central post of the baseplate for additional security.
The glenospheres are manufactured from Co-Cr-Mo conforming to ISO 5832-12. The glenosphere screw is manufactured from Ti-6Al-4V conforming to ISO 5832-3.
The humeral cups are one-piece constructs consisting of a pre-assembled Ti-6Al-4V alloy shell and a UHMWPE insert. A 24mm diameter tapered post on the inferior surface of the shell locks into the female taper on the superior surface of the humeral stem. The humeral cups are available in 36mm and 40mm diameters and in standard and mobility styles. The standard cups offer a slightly deeper articular surface to provide additional constraint while the mobility cups are not as deep to provide slightly less constraint. The humeral cups are available in heights of +3mm, +6mm.
If additional height of the humeral articulation is needed, a +9mm humeral spacer can be used between the humeral stem and the humeral cup. The +9mm humeral spacer adds 9mm of height resulting in construct heights of +12mm, +15mm. The spacer has a 24mm male taper that mates with the humeral stem and a 24mm female taper that mates with the humeral cup.
The humeral cups are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and UHMWPE conforming to ISO 5834-1 and ISO 5834-2. The +9mm humeral spacers are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.
The Humelock Reversed Shoulder includes both cemented humeral stems. The cementless humeral stems are available in diameters 8 to 16 mm. The distal end is cylindrical with a grit blasted surface and two unthreaded screw holes oriented in the medial/lateral direction. Bone screws can be used to provide additional early fixation and stability of the stem. Cortical bone screws are available in lengths from 18 - 40mm in 2mm increments. The proximal portion of the cementless humeral stem has a plasma sprayed CP Titanium and Hydroxyapatite coating.
Cemented stems are available in diameters 6 to 14 mm. The distal end of the cemented humeral stem is trapezoidal with a polished surface. The cemented humeral stems incorporate a 24mm diameter female taper for attachment of compatible components.
Both the cementless and cemented stems are compatible with an optional spoiler, which can be attached to the lateral side of the stem to provided additional resistance to rotation. The spoiler is fixed to either stem using an M6 hex screw.
The spoiler and hex screw are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.
During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, the Humelock Reversed cementless and cemented stems can be used with an eccentric taper adapter and 50, 52 or 54mm eccentric humeral heads for conversion to an anatomic shoulder hemi-arthroplasty. The taper adapter has a 24mm male taper to mate with the humeral stem and a 10mm male taper to mate with the humeral head. The taper adapter is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The eccentric humeral heads are manufactured from wrought Co-Cr-Mo conforming to ISO 5832-12.
This document does not contain an acceptance criteria table or a study description as typically found in submissions for AI/ML-based medical devices. The document is a 510(k) premarket notification for a Class II medical device, the Humelock Reversed Shoulder, a type of shoulder prosthesis.
Here's why the requested information isn't available in this document:
- Device Type: This document pertains to a physical medical device (a shoulder joint prosthesis), not a software or AI/ML-based diagnostic/therapeutic tool.
- Regulatory Pathway: The 510(k) pathway for traditional medical devices primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, often through non-clinical performance testing (mechanical, biocompatibility, etc.) rather than extensive clinical studies with specific performance metrics like accuracy, sensitivity, or specificity commonly seen in AI/ML device submissions.
- Focus of Testing: The non-clinical testing described (range of motion, fatigue, torsional fatigue, pyrogenicity) evaluates the physical and mechanical integrity and safety of the implant, not its diagnostic or predictive performance.
Therefore, I cannot provide the requested information. The document explicitly states under "Clinical Testing": "Clinical testing was not necessary to determine substantial equivalence of the Humelock Reversed Shoulder to the predicate devices." This confirms that no clinical study, of the type you're asking about, was conducted or required for this particular 510(k) submission.
§ 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.”