The CSS Cannulated Screw System consists of cannulated screws of various diameters, lengths and thread configurations. The system also includes correspondingly sized washers, the use of which are optional, as well as guide wire and various instruments.
The cannulated screws are self tapping. They are made from made from Titanium Ti-6Al-4V ELI Alloy in conformance with ASTM F-136 Standard Specification for Wrought Titanium 6Al-4V ELI Alloy for Surgical Implant Applications.
The CSS System includes (4) different types of washers. These are; Flat Washers, Contoured Washers, Partial Contoured Washers, and Domed Washers. The various styles are intended to offer the surgeon a variety of anatomical fit to the bone in certain applications.

AI/ML Overview

The provided text describes the CSS Cannulated Screw System and its substantial equivalence to a predicate device, the Howmedica Asnis III Cannulated Screw System (K000080).

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Performance Measure)	Reported Device Performance (CSS Cannulated Screw System)
Substantial Equivalence to Predicate Device (Howmedica Asnis III) in terms of mechanical performance.	Results clearly demonstrate that the CSS System is substantially equivalent to its' predicate based on Finite Element Analysis (FEA) and performance testing.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a separate "test set" in the context of clinical data for the device's performance. The performance evaluation was primarily mechanical and computational.

Sample size for test set: Not applicable in the context of human data. For the mechanical and computational analysis, the "samples" would refer to the designs modeled and tested. The document implies a comparison of the CSS Cannulated Screw System against the predicate device.
Data provenance: Not applicable. The data is from in-vitro mechanical testing and computational modeling (Finite Element Analysis) performed by the manufacturer, OrthoHelix Surgical Designs, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. Ground truth in this context refers to mechanical properties and substantial equivalence, not clinical diagnostic accuracy or efficacy requiring expert consensus for a test set.

4. Adjudication Method for the Test Set:

Not applicable. This concept pertains to resolving discrepancies in expert interpretations of clinical data, which is not relevant to this type of device submission.

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. The CSS Cannulated Screw System is a physical medical device (cannulated screws) for orthopedic fixation, not a software or AI-driven diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. As noted above, this device is not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for demonstrating substantial equivalence was the known mechanical performance and design specifications of the legally marketed predicate device, the Howmedica Asnis III Cannulated Screw System. This served as the benchmark against which the CSS Cannulated Screw System's performance (via FEA and performance testing) was compared.

8. The Sample Size for the Training Set:

Not applicable. The concept of a "training set" typically refers to data used to train machine learning models and is not relevant to the evaluation of this physical medical device. The design and materials are based on established engineering principles and materials science for medical implants.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set in the context of machine learning, no ground truth was established for it. The design and manufacturing process would adhere to established standards (e.g., ASTM F-136) and engineering best practices for orthopedic implants.

Summary

{0}------------------------------------------------

510(k) Premarket Notification

CSS Cannulated Screw System

510(k) SUMMARY

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

OrthoHelix Surgical Designs, Inc. 1815 W. Market Suite 205 Akron, Ohio 44313 Phone: (330) 869-9563 Fax: (330) 869-9583

Contact Person: Lee A. Strnad Senior Development Manager OrthoHelix Surgical Designs, Inc.

Date Prepared: February 13, 2006

Name of Device

CSS Cannulated Screw System

Common or Usual Name

Cannulated Screws

Classification Name

Screw, Fixation, Bone

Single/Multiple Component Metallic Fixation Appliances and Accessories

Predicate Devices

Howmedica Asnis III Cannulated Screw System (K000080)

Intended Use

The CSS Cannulated Screw System will be indicated for use in long and small bone fracture fixation, which includes the following;

· Fractures of the tarsals and metatarsals

{1}------------------------------------------------

510(k) Premarket Notification

CSS Cannulated Screw System

· Fractures of the olecranon, distal humerous
· Fractures of the radius and ulna
· Patella fractures
· Distal tibia and pilon fractures
· Fractures of the fibula, medial malleolus, os calcis
· Tarso-metatarsal and metatarsal phalangeal arthrodesis
· Metatarsal and phalangeal osteotomies
· Osteochondritis dissecans
· Ligament fixation
· Other small fragment, cancellous bone fractures and osteotomies

Device Description

The cannulated screws are self tapping. They are made from made from Titanium Ti-6Al-4V ELI Alloy in conformance with ASTM F-136 Standard Specification for Wrought Titanium 6Al-4V ELI Alloy for Surgical Implant Applications.

The CSS System includes (4) different types of washers. These are; Flat Washers, Contoured Washers, Partial Contoured Washers, and Domed Washers. The various styles are intended to offer the surgeon a variety of anatomical fit to the bone in certain applications.

Performance Data

A Finite Element Analysis (FEA) was performed on the CSS Cannulated Screw System, in comparison to its' predicate, the Asnis III. Performance testing was also conducted to confirm the results of the FEA. Results clearly demonstrate that the CSS System is substantially to its' predicate.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 7

OrthoHelix Surgical Designs, Inc. C/o Mr. Lee A. Strnad Senior Development Manager 1815 West Market Street, Suite 205 Akron, Ohio 44313

Re: K060428

Trade/Device Name: CSS Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HWC, HTN Dated: February 13, 2006 Received: February 21, 2006

Dear Mr. Strnad:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Mr. Lee A. Strnad

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Qmee

Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K060428

Indications for Use

510(k) Number (if known): TBD

Device Name: CCS Cannulated Screw System

Indications for Use: The CSS Cannulated Screw System will be indicated for use in long and small bone fracture fixation, which includes the following:

Fractures of the tarsals and metatarsals .
Fractures of the olecranon, distal humerous
Fractures of the radius and ulna �
Patella fractures ●
Distal tibia and pilon fractures .
Fractures of the fibula, medial malleolus, os calcis ●
Tarso-metatarsal and metatarsal phalangeal arthrodesis .
Metatarsal and phalangeal osteotomies
Osteochondritis dissecans
Ligament fixation

Other small fragment, cancellous bone fractures and osteotomies
Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Page ___ of ___
-----------------	--

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	K060428
---------------	---------

Regulation Number and Section

§ 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.