(67 days)
To offer KLS Martin Quick Disc, KLS Martin Sternal Talon and KLS Martin Sternal Plating System in sterile packaging with the following indications for use:
K062857 KLS Martin Quick Disc is intended for reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures.
K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for stabilization and fixation of antenor chest wall fractures including sternal fixation subsequent to stemotomy and sternal reconstructive procedures.
The KLS Martin Quick Disc is a two-sided cranial closure device. The lower disc is attached to a threaded post. The upper disc is threaded down and locked on the post securely holding the bone flap in place. The KLS Martin Quick Disc diameters range from 12mm to 22mm in size
The KLS-Martin Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open
A second emergency re-entry is position. provided by cut points adjacent to the screw.
KLS - Martin Sternal Plating System consists of plates having a thickness from 1.0mm to 3.0mm and screws having a diameter of 2.3mm to 3.2mm.
This 510(k) premarket notification describes the KLS Martin Quick Disc, Sternal Talon, and KLS Martin Sternal Plating System in sterile packaging. The submission asserts substantial equivalence to previously cleared devices based on identical manufacturing and materials, with the primary difference being the sterile packaging and associated new stock numbers.
Here’s a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the way that would typically be seen for a novel device or a device with new technological characteristics requiring performance testing.
Instead, the submission leverages "substantial equivalence" to predicate devices. This means the performance is assumed to be equivalent to the predicate devices because the new device (KLS Martin Quick Disc, Sternal Talon, and Sternal Plating System in sterile packaging) is identical in manufacturing and materials to the non-sterile versions and substantially equivalent in sterilization and packaging to an already cleared sterile fixation system.
Therefore, the "acceptance criteria" here are met by demonstrating the following:
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Manufacturing and Materials: Identical to previously cleared, non-sterile versions (K062857, K051165, K032413). | Performance of the sterile Quick Disc, Sternal Talon, and Sternal Plating System is identical to their non-sterile predicate devices. This implies mechanical and functional equivalence. |
| Sterilization and Packaging: Identical to a previously cleared sterile fixation system (KLS Martin Rigid Fixation - Sterile K060177). | Performance related to sterility and packaging integrity is equivalent to the KLS Martin Rigid Fixation - Sterile (K060177). This implies maintained sterility and packaging effectiveness. |
| Intended Use/Indications: Same as the predicate devices. | The devices are intended for reattachment of cranial bone flaps, covering burr holes, fixation of cranial fractures (Quick Disc), and stabilization/fixation of anterior chest wall fractures including sternal fixation after sternotomy and sternal reconstructive procedures (Sternal Talon and Sternal Plating System). |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable. This submission relies on substantial equivalence to predicate devices, not on a new performance study with a test set of data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No new clinical or performance data requiring expert ground truth establishment for a test set was generated or submitted for this 510(k). The equivalence is based on engineering and material comparisons.
4. Adjudication Method for the Test Set
- Not applicable. No new performance study or test set requiring adjudication was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is not relevant to a submission based on substantial equivalence for a change in packaging and sterilization for an already cleared mechanical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is a mechanical surgical implant device, not an AI/algorithm-based diagnostic or therapeutic tool.
7. The Type of Ground Truth Used
- Not applicable / Implied by Predicate Device Clearance. The "ground truth" for the safety and effectiveness of these devices is implicitly established by the prior clearance of the predicate devices, which would have undergone their own regulatory review processes, potentially including clinical data, bench testing, and material biocompatibility assessments, all of which would have been reviewed by the FDA. For this 510(k), the "ground truth" is that the sterile versions are physically and functionally identical to the already cleared non-sterile versions, and their sterilization is equivalent to another cleared sterile device.
8. The Sample Size for the Training Set
- Not applicable. No training set for an algorithm was used or described.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set for an algorithm was used or described.
§ 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.