(93 days)
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis: .
- Inflammatory degenerative joint disease such as rheumatoid arthritis: .
- Treatment of acure fractures of the humeral head that cannot be treated with other fracture fixation . methods:
- Revision of a failed primary implant; .
- . " Cuff tear arthropathy (CTA Heads only).
The Large Resection Stems (not available in the US) are indicated for oncology applications.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). 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.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented use as specified in the following table.
In the Anatomic shoulder the humeral consists of the humeral stem. the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid consists of the metal back, the connector and the glenosphere. On the glenoid side, the fixation of the all polyethylene glenoid or the metal-back-determines if the construct is cemented or uncemented.
The SMR 3-Pegs Glenoids are made from standard UHMWPE ). They are intended for cemented fixation only.
The SMR 3-Pegs Glenoids are available in two sizes (Small and Standard). They are characterized by an articulating surface with a radius of curvature greater than the corresponding humeral head. This mismatch allows for translation of the head in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has three pegs for fixation in the glenoid.
The SMR 3-Pegs Glenoids are designed to articulate with the Limacorporate SMR humeral heads indicated for use in total shoulder replacement.
This document describes the premarket notification (510(k)) for the Limacorporate SMR 3-Pegs Glenoids, a component for shoulder joint replacement. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The device is a medical implant, and its performance is evaluated based on mechanical and material properties, rather than diagnostic accuracy as would be common for AI devices. Therefore, the "acceptance criteria" here refer to meeting established mechanical testing standards and material specifications, and "reported device performance" refers to the results of those tests confirming compliance.
| Acceptance Criteria (Mechanical/Material) | Description | Reported Device Performance |
|---|---|---|
| ASTM F1829 Compliance | Standard Test Method for Static Evaluation of Glenoid Locking Mechanism in Shear. This standard assesses the static mechanical shear strength of the glenoid component and its ability to resist translation relative to the bone or fixation. | Mechanical testing performed. Results demonstrated the device's ability to perform under expected clinical conditions. (Exact numerical results not provided in summary) |
| ASTM F2028 Compliance | Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation. This standard assesses the dynamic mechanical fatigue strength of the glenoid component and its resistance to loosening or disassociation under physiological loading. | Mechanical testing performed. Results demonstrated the device's ability to perform under expected clinical conditions. (Exact numerical results not provided in summary) |
| Range of Motion Simulation | Ensure the device design does not overly limit the range of motion of the shoulder joint when implanted. | Range of Motion simulation performed. Results ensured that the device design does not overly limit range of motion. |
| Material Specifications | Made from standard Ultra-High Molecular Weight Polyethylene (UHMWPE) or UHMWPE X-Lima. | The SMR 3-Pegs Glenoids are made from UHMWPE, or UHMWPE X-Lima, the same material as other cleared SMR System cemented glenoids. |
| Sterilization | Sterilized by ethylene oxide (EtO) with a Sterility Assurance Level (SAL) of 10-6 and a shelf life of 5 years. | Sterilization method (EtO), SAL, and shelf life are identical to cleared cemented glenoids of the SMR Systems. |
2. Sample Sizes Used for the Test Set and Data Provenance
This is a medical device approval based on non-clinical testing (mechanical and materials), not an AI/software device. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the same way they would be for an AI study.
- Test Set Sample Size: "All mechanical testing was done on worst case components or constructs." The specific number of physical units tested is not provided in this summary.
- Data Provenance: Not applicable as it's mechanical testing of physical components, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for mechanical testing is established by conforming to predefined engineering standards (ASTM standards) and manufacturing specifications, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as this refers to expert review of clinical data, which was not performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI device or an imaging device requiring human reader interpretation. No MRMC study was performed.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device. There is no algorithm, and therefore no standalone algorithm performance to evaluate.
7. Type of Ground Truth Used
The "ground truth" for this medical device submission is established through:
- Engineering Standards: Compliance with established ASTM (American Society for Testing and Materials) standards (F1829 and F2028) for mechanical properties relevant to glenoid components.
- Material Specifications: Adherence to specifications for UHMWPE and UHMWPE X-Lima.
- Design Specifications: Ensuring the dimensions and design features (e.g., radius of curvature, peg design) match those of legally marketed predicate devices and achieve their intended purpose (e.g., range of motion).
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device approval. Performance is demonstrated through direct mechanical testing and comparison to predicate device characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.”