(90 days)
The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plate, short (Length =1 1 5mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the greater trochanter.
The NCB Periprosthetic Trochanter Plate when used in combination with the NCB Periprosthetic Proximal Femur Plates (Length =245mm, 324mm, 363mm, 401mm) is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the proximal femur.
In addition, both combinations are indicated for:
- · Re-attachment of the greater trochanter following osteotomy in THA
- Re-attachment of the greater trochanter following fracture of greater trochanter
- · Periprosthetic fractures
- Comminuted fractures
- · Fractures in osteopenic bone
- · Nonunions
- · Malunions
The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in long bones.
-
The NCB (Non-Contact-Bridging) Periprosthetic Trochanter Plates and Screws are a line of locking plates for the treatment of proximal femur fractures, which includes greater trochanter fractures and osteotomies. The NCB Periprosthetic Trochanter Plate and the Connection Screw for NCB Periprosthetic Trochanter Plate are used in combination with the NCB Periprosthetic Proximal Femur Plate, short (Length =115mm). The NCB Periprosthetic Trochanter Plate can also be used in combination with the existing NCB Periprosthetic Proximal Femur Plates (Length =245mm, 285mm, 324mm, 363mm, 401mm) from the NCB Periprosthetic Femur Polyaxial Locking Plate System. The NCB System technology used on the NCB Periprosthetic Proximal Femur Plates allows for polyaxial screw placement (30° cone) with screw locking achieved with the use of locking caps that are threaded into the plate holes. The NCB Periprosthetic Trochanter Plate contains threaded conical holes which allow for monoaxial screw placement using locking screws with threaded heads. Non-locking cortical screws can also be used. All the plates are made of Ti-6Al-4V alloy. The Connection Screw for NCB Periprosthetic Trochanter Plate is also made of Ti-6Al-4V alloy.
-
The NCB Cable Button for NCB Polyaxial Locking Plate is a temporary internal fixation component used in conjunction with Zimmer NCB Plates, Zimmer NCB Periprosthetic Plates and Cerclage Cables. The Cable Button is threaded into a vacant screw hole of Zimmer NCB Plates or Zimmer NCB Periprosthetic Plates and provides a positioning point for a Cerclage Cable. The Cable Button is made up of Ti-6Al-4V alloy and is color anodized.
This 510(k) summary (K120772) describes the Zimmer NCB Periprosthetic Trochanter Plates and Screws and the NCB Cable Button for NCB Polyaxial Locking Plate. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-clinical submission for orthopedic implants, the "acceptance criteria" and "reported device performance" are typically defined by engineering standards for mechanical strength, fatigue, and other biomechanical properties. The document does not provide specific numerical acceptance criteria or performance values beyond stating that the testing "demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices."
The types of tests performed indicate the implicit acceptance criteria:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| NCB Periprosthetic Trochanter Plates and Screws: | |
| Torsional strength of Connection Screw | Demonstrated safety, effectiveness, and substantial equivalence to predicate devices. |
| Fatigue strength of Periprosthetic Trochanter Plate (with/without cable and hex button) | Demonstrated safety, effectiveness, and substantial equivalence to predicate devices. |
| Stiffness of Periprosthetic Trochanter Plate | Demonstrated safety, effectiveness, and substantial equivalence to predicate devices. |
| Removal Torque of ULS Tivanium® Ti-6Al-4V Alloy 3.5mm locking screws | Demonstrated safety, effectiveness, and substantial equivalence to predicate devices. |
| NCB Cable Button for NCB Polyaxial Locking Plate: | |
| Seating and Removal Torque of Cable Button | Demonstrated safety, effectiveness, and substantial equivalence to predicate devices. |
| Loading analysis of Cable Button | Demonstrated safety, effectiveness, and substantial equivalence to predicate devices. |
| Overall: Substantial equivalence to predicate devices for intended use, materials, sterility, and performance characteristics. | The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of samples (e.g., number of plates, screws, cable buttons) used for each non-clinical test. This information is typically detailed in the full test reports, which are not included in this summary.
- Data Provenance: The data is from non-clinical (lab) performance testing. The location of the testing is not explicitly stated, but Zimmer's address is Switzerland, and the contact person is in Indiana, USA. However, the tests are physical engineering tests, not involving human or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a non-clinical submission involving mechanical testing of orthopedic implants, "ground truth" is established by adherence to recognized engineering standards and methodologies (e.g., ASTM, ISO). The performance is assessed against these standards and compared to previously cleared predicate devices, not against expert human interpretations of images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study requiring adjudication of expert opinions. The "adjudication" in a non-clinical context would be the review and verification of test protocols, data, and conclusions by qualified engineers and regulatory specialists.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This submission is for mechanical orthopedic implants, not an AI software device, and therefore no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for mechanical orthopedic implants, not an AI software device.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established engineering principles, biomechanical testing standards, and comparative performance to legally marketed predicate devices. This includes:
- Physical measurements of strength, stiffness, fatigue life, and other mechanical properties.
- Conformity to material specifications (Ti-6Al-4V alloy).
- Demonstration of substantial equivalence to the performance characteristics of predicate devices in identical or similar non-clinical tests.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not a machine learning or AI device that requires a training set or its associated ground truth establishment.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.