(64 days)
The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide internal fixation with minimal soft tissue irritation. It is a system which optimally engages the femoral head and permits impaction of bone fracture fragments. Osteo Cortical Bone Screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The Osteo Compression Hip Screw System is indicated for the following proximal fractures of the femur:
- Intracapsular fractures of the femoral neck. .
- Intertrochanteric fractures of the femur. .
The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo Cortical Bone Screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues.
Osteo Compression Hip Screw Plates:
The subject Osteo Compression Hip Screw Plates are part of the Osteo Compression Hip Screw System. These plates are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile and sterile.
130° Compression Hip Screw Plates: The Osteo 130° Compression Hip Screw Plates are available in three lengths (75mm, 91mm, and 107mm) with 4, 5, and 6 screw holes, respectively, for varied clinical situations. All plates have a 38mm barrel length and feature a 130° barrel angle. The barrel slides over the inserted lag screw; a compression screw may be used for additional compression of the fracture area. These plates have round holes which accommodate Osteo Cortical Bone Screws with a 4.5mm diameter.
Short Barrel Compression Hip Screw Plates: The Osteo Short Barrel Compression Hip Screw Plates are available in lengths of 75mm and 107mm, with either 4 or 6 screw holes, and two barrel angles (135° and 150°) for varied clinical situations. All plates have a 25mm barrel length.
Osteo Super Lag Screw:
The Osteo Super Lag Screw is available in lengths from 50mm to 145mm. All Osteo Super Lag Screws feature a 22mm thread length,14mm thread diameter, and self tapping thread. These lag screws are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM), and are offered both non-sterile and sterile.
This document is a 510(k) Premarket Notification for the Osteo Compression Hip Screw System - Product Line Extensions. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study with acceptance criteria.
Therefore, many of the requested sections about explicit acceptance criteria and a study proving those criteria are not directly available in this type of submission. 510(k) submissions for devices like this typically rely on comparison to existing legally marketed devices, material testing, and design features to demonstrate safety and effectiveness, rather than clinical efficacy studies with specific performance metrics and acceptance criteria.
However, I can extract information related to the device description and intended use, and explain why other sections are not present.
Acceptance Criteria and Reported Device Performance:
No explicit acceptance criteria or reported device performance metrics are provided in this 510(k) submission. The submission is based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance targets from a clinical study.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable - 510(k) submission focuses on substantial equivalence rather than explicit performance criteria. | Not explicitly reported as a performance study was not conducted for this 510(k) clearance. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable. This 510(k) submission does not describe a clinical performance study with a test set.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This 510(k) submission does not describe a clinical performance study requiring expert adjudication for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi-reader multicase (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 device is a mechanical orthopedic implant, not an AI-driven diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As a mechanical orthopedic implant demonstrating substantial equivalence, "ground truth" in the context of diagnostic accuracy or clinical outcomes is not the primary focus of this 510(k) submission. The "truth" here relates to the safety and mechanical function being similar to the predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Additional Information from the Submission:
- Device Description: The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw. It is intended to provide strong and stable internal fixation with minimal soft tissue irritation for intertrochanteric and intracapsular femoral neck fractures.
- Predicate Device: The Howmedica Omega Plus Compression Hip Screw System.
- Basis for Clearance: Substantial equivalence in design, materials, and intended use to the predicate device. The materials are ASTM F-138 Stainless Steel (Grade 2, 316LVM).
- This 510(k) is for "Product Line Extensions" of an existing system, indicating that the core technology was likely cleared previously.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.