The Dynamic Hip Screw System devices are used in the treatment of femoral neck fractures in the pertrochanteric, intertrochanteric and high subtrochanteric regions of the femur, or in the treatment of combinations of these fractures.

Pertrochanteric fractures occur from the greater to lesser trochanter. Intertrochanteric fractures occur within the trochanteric area. High subtrochanteric fractures occur immediately below the trochanter.

The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral fracture.

The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.

Device Description

The Dynamic Hip Screw System comprises stainless steel Dynamic Compression Plates and Compression Lag Screws and optional Hexagonal Screw for use in the fixation of femoral neck fractures.

The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral neck fracture. The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.

A dedicated Corifix Dynamic Hip Screw instrument set is used to implant the devices or Stratetc (Synthes) instruments may be used.

Each of the implantable devices is manufactured form stainless steel which in certified to BS 7252 Part 1.

AI/ML Overview

This is a 510(k) summary for the Corifix Dynamic Hip Screw System, a medical device for femoral neck fractures. The document is a premarket notification for a traditional medical device, not an AI/ML SaMD, so the requested information about acceptance criteria and study data relevant to AI/ML performance is not applicable. The device is a physical implant, and its equivalence is based on material and structural similarity to a predicate device.

Here's a breakdown of why this submission doesn't contain the requested AI/ML-specific information:

Device Type: This is a physical orthopedic implant (Dynamic Hip Screw System), not a software device or an AI/ML-powered system.
Approval Pathway: This is a 510(k) submission, specifically demonstrating substantial equivalence to a predicate device (Stratec (Synthes) DHS System). This pathway focuses on comparing the new device's design, materials, and intended use against a legally marketed predicate, rather than providing extensive clinical trial data for novelty or performance claims.

Therefore, the following points from your request are not present or applicable in this document:

A table of acceptance criteria and the reported device performance: This document doesn't provide specific performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). Acceptance criteria here relate to manufacturing standards (BS 7252 Part 1 for stainless steel) and design similarities to the predicate.
Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 device does not involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for this device's acceptance is its substantial equivalence to the predicate device, supported by material specifications and design dimensions.
The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
How the ground truth for the training set was established: Not applicable.

Summary of Device Acceptance Information from the Document:

Acceptance Criteria & Reported Performance (Based on Substantial Equivalence):

Acceptance Criterion (Similarity to Predicate)	Reported Device Performance (Corifix DHS System)
Material	Manufactured from 316 LVM stainless steel
Plate Angles & Holes	Similar range of plate angles and holes
Intended Use	Designed to treat proximal hip fractures
Plate Thickness & Width	Same thickness and width as predicate
Outside Barrel Diameter	Same outside barrel diameter as predicate
Clinical Use History	In clinical use outside USA for three years with no postoperative problems reported. Competitor's device has been in clinical use for over twenty years with no significant problems.

Study Information Pertaining to Traditional Device Submission:

Study That Proves the Device Meets Acceptance Criteria: The submission is a comparison study demonstrating substantial equivalence to the Stratec (Synthes) DHS System, which is a legally marketed predicate device. The "proof" lies in the direct comparison of design characteristics and materials.
Sample Size Used: Not applicable in the sense of a clinical trial or AI test set. The comparison is made against the specifications and design of the predicate device.
Data Provenance: Not applicable for AI/ML. For this traditional device, the data provenance relates to the specifications of the Corifix device and the predicate device. Clinical use history mentioned (3 years for Corifix outside USA, 20+ years for predicate) is likely gathered from market surveillance or internal records, not a specific "study" with a defined sample size in the clinical trial sense.
Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device. The Corifix system is deemed substantially equivalent because its characteristics sufficiently match those of the predicate, and it uses materials certified to a recognized standard (BS 7252 Part 1).

Summary

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510(k) SUMMARY

Name of Company:	Corifix LtdThe Corinium CentreCirencesterGloucestershireGL7 1YJEngland
Name of Device:	Corifix Dynamic Hip Screw System

The Dynamic Hip Screw System comprises stainless steel Dynamic Device Description: Compression Plates and Compression Lag Screws and optional Hexagonal Screw for use in the fixation of femoral neck fractures.

A dedicated Corifix Dynamic Hip Screw instrument set is used to implant the devices or Stratetc (Synthes) instruments may be used.

Each of the implantable devices is manufactured form stainless steel which in certified to BS 7252 Part 1.

SUBSTANTIAL EQUIVALENCE AND SAFETY AND SUMMARY OF EFFECTIVENESS

The Corifix Dynamic Hip Screw System is substantially equivalent to the Stratec (Synthes) DHS System for the following reasons:

Both are manufactured from 316 LVM stainless steel. a)
Both have a similar range of plate angles and holes. b)
c) Both are designed to be used to treat proximal hip fractures.
Both of the plates are the same thickness and width. d)
Both have the same outside barrel diameter. e)

This type of device has been in clinical use for over twenty years and no significant problems have been reported.

The Corifix Hip Screw has been in clinical use outside the USA for three years and no postoperative problems have been reported.

The Corifix product design is generic and equivalent to the Synthes DHS System.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird, with three human profiles incorporated into its design. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Mr. Craig Corrance President Corin U.S.A. 10500 University Center Drive Suite 130 Tampa, Florida 33612

K973231 Re: Corifix Dynamic Hip Screw Trade Name: Regulatory Class: II Product Code: COKTT Land: Comm Dated: August 12, 1997 Received: August 27, 1997

Dear Mr. Corrance:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਖੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Craig Corrance

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

G. Celia M. Whitton, Ph.D., M.

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

The Corifix Dynamic Hip Screw System Device Name:

INDICATIONS FOR USE

Pertrochanteric fractures occur from the greater to lesser trochanter. Intertrochanteric High subtrochanteric fractures occur fractures occur within the trochanteric area. immediately below the trochanter.

The devices provide support to the femur and femoral head during the natural process of bone regeneration to repair the femoral fracture.

The devices are designed to withstand the in vivo loads experienced during normal activity throughout the life of the implant.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation

signature

(Division Sign-Off) Division of General Restorative Devices

510(k) Number K973231

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 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.