The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

Device Description

The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The 2.5mm screw is available in 7 length configurations between 12mm - 24mm, with increments of 2mm. The 3.5mm screw is available in 7 length configurations between 14mm - 26mm, with increments of 2mm. The system is provided non-sterile and is sterilized in the user facility.

AI/ML Overview

The provided 510(k) summary for the Skeletal Dynamics Headless Compression Screw System describes a medical device (bone screw), not an AI/ML powered device or diagnostic software. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," and "training set sample size," are not applicable to this type of device and submission.

The acceptance criteria and study described pertain to proving substantial equivalence to a predicate device based on mechanical performance.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Substantial equivalence in compressive force testing to predicate device (HBS Headless Bone Screw (K030302)).	Preclinical compressive force testing demonstrated that the Skeletal Dynamics Headless Compression Screw is substantially equivalent to the predicate device.

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

Sample Size: Not explicitly stated. The document mentions "Preclinical compressive force testing," implying a laboratory-based study on physical samples of the screws.
Data Provenance: The data is generated from preclinical, laboratory-based mechanical testing of the device itself. This is not patient data from a specific country, nor is it retrospective or prospective in the clinical sense.

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

Not Applicable. For a medical device like a bone screw, "ground truth" is typically defined by engineering specifications and material properties, validated through standardized mechanical testing methods, rather than expert interpretation of data.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for mechanical performance testing of bone screws.

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 is a hardware medical device; it does not involve human readers or AI assistance.

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

Not Applicable. This is a hardware medical device; there is no algorithm involved.

7. The Type of Ground Truth Used:

The "ground truth" for this type of device is the mechanical performance (e.g., compressive strength) of the screws as measured in a laboratory setting, compared against a predicate device. This is based on engineering specifications and established mechanical testing standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.

Summary

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K112672

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510(k) Summary of Safety and Effectiveness Skeletal Dynamics Headless Compression Screw System

September 9, 2011

Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 201 Miami, FL 33176 Tel: (305) 596-7585 Fax: (305) 596-7591 Contact: Ana M. Escagedo, Vice President Email: aescagedo@skeletaldynamics.com

Establishment Registration Number: 3006742481

Trade Name, Common Name, Classification:

Trade Names Headless Compression Screw System Common Name Screw, fixation, bone 21 CFR §888.3040 Classification Product Code HWC Class Class II

Predicate Devices:

HBS Headless Bone Screw (K030302)

Description of the Device:

The system is provided non-sterile and is sterilized in the user facility.

Intended Use:

Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head

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fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Headless Compression Screw System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness.

Performance Testing:

Preclinical compressive force testing demonstrated that the Skeletal Dynamics Headless Compression Screw is substantially equivalent to the predicate device which is currently marketed. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

Conclusion:

The Skeletal Dynamics Headless Compression Screw System is substantially equivalent to the predicate device identified in this premarket notification.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

DEC 1 3 2011

Skeletal Dynamics, LLC % Ana M. Escagedo 8905 SW 87 Avenue. Suite 201 Miami. FL 33176

Re: K112672

Trade/Device Name: Headless Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 9th, 2011 Received: September 14th, 2011

Dear Ms. Escagedo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Ana M. Escagedo

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 CER Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Erine Keith

13 Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): k//2672

Device Name: Headless Compression Screw System

Indications For Use: The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include:

Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

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(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K11267d

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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.