The Wrist Arthrodesis Nail System is intended for wrist arthrodesis. Specific indications include posttraumatic arthritis of the joints of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis of the wrist, severe unremitting wrist pain related to motion, brachal plexus nerve palsies, tumor resection, and spastic deformities.

Device Description

The Wrist Arthrodesis Nail System is designed as an intramedullary nailing platform to address wrist arthrodesis procedures utilizing a minimally invasive dorsal approach into the third metacarpal and distal radius by trained physicians. The IMPLATE Wrist Arthrodesis Nails are secured within the intramedullary canals by means of bone screws, and then assembled into a completed construct using a Connector. The IMPLATE Wrist Arthrodesis Nail System is comprised of a titanium (Ti 6AL-4V) Distal Radius Intramedullary Nail, various lengths of titanium (Ti 6AL-4V) Metacarpal Intramedullary Nails, multiple titanium (Ti 6AL-4V) nail Connectors in various lengths and angles, and Unicortical Screws of various lengths, Pins and System specific instrumentation

AI/ML Overview

The acceptance criteria and the study proving the Skeletal Dynamics Wrist Arthrodesis Nail System meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria	Reported Device Performance
Static four-point bending test (ASTM F82)	Demonstrate bending strength comparable to the predicate device, with no failure.	All subject devices tested passed the acceptance criteria without failure, demonstrating comparable yield point and bending stiffness to the predicate.
Dynamic four-point bending test (ASTM F1264)	Achieve a maximum run-out value at 1,000,000 cycles without failure.	The testing confirmed an endurance value of 1,000,000 cycles without evidence of failure.
Torque Test (Connector Strength)	Withstand torsional forces without failure.	All subject devices tested passed the acceptance criteria without evidence of failure.
Pull Test (Interconnection Strength)	Maintain secure interconnection between the connector, metacarpal, and radius nails without failure.	All subject devices passed the acceptance criteria without evidence of failure.
Cadaver Lab (Surgical Procedure Repeatability)	Demonstrate that the surgical procedure is feasible and repeatable. (Implicit acceptance: successful completion and documentation of the procedure).	The lab documented that the procedure is feasible and repeatable, confirming successful and consistent surgical execution.

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

The document does not specify exact numerical sample sizes for each mechanical test performed (e.g., how many nails or connectors were tested). It generally refers to "All subject devices tested." The cadaver lab's sample size is also not specified numerically.

Regarding data provenance, the document does not provide details on the country of origin or whether a retrospective/prospective study design was used for any of the tests. These are non-clinical (mechanical and cadaveric) tests.

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

This information is not applicable for this device as the studies conducted are non-clinical (mechanical and cadaveric) and do not involve human subject data or ground truth established by experts in a diagnostic or clinical evaluation context. The "experts" in this context would be the engineers and technicians performing the tests, and the surgeons in the cadaver lab; however, their number and formal qualifications beyond "trained physicians" (for the cadaver lab) are not detailed.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical or diagnostic studies involving human assessment or interpretation (e.g., reviewing medical images). These engineering and cadaveric tests do not involve such adjudication. The acceptance criteria for each test (e.g., "without failure," "confirmed endurance value") serve as the definitive evaluation metric.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or algorithms, often involving human readers interpreting medical data with and without AI assistance. The Wrist Arthrodesis Nail System is a medical implant, and its evaluation focuses on mechanical properties and surgical feasibility.

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

No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an algorithm or AI system. The tests performed are for the physical properties and surgical utility of the device itself.

7. The Type of Ground Truth Used

For the mechanical tests, the "ground truth" is defined by the predetermined physical and engineering standards set by ASTM (e.g., F82, F1264) and the specific design requirements of the device (e.g., strength of connectors). Failure to meet these established engineering specifications constitutes a deviation from the "truth" of acceptable performance.

For the cadaver lab, the ground truth is the demonstrable feasibility and repeatability of the surgical procedure in an anatomical context.

8. The Sample Size for the Training Set

This medical device is a physical implant, not an AI or machine learning model. Therefore, there is no "training set" in the context of data used to train an algorithm. The development of the device's design would have involved iterative prototyping and testing, but these are distinct from a training set for an AI system.

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

As stated above, there is no "training set" for this device in the context of AI. The "ground truth" for the device's design and manufacturing process would be established through engineering principles, material science, and adherence to relevant industry standards (e.g., ASTM) and regulatory requirements.

Summary

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K092720

JUN 2 9 2010

510(k) Summary of Safety and Effectiveness Wrist Arthrodesis Nail System System

June 18, 2010

Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 102 Miami, FL 33176 Tel: (305) 596-7585 Contact: Ana M. Escagedo / Vice President Quality & Regulatory Affairs Email: aescagedo@skeletaldynamics.com

FDA Establishment Registration Number: Pending

Trade Name, Common Name, Classification: Device Trade Name: Wrist Arthrodesis Nail System IMPlate Wrist Arthrodesis Nails

Device Common or Usual Names: Intramedullary fixation rod

Product Code: HSB

Classification: Class II, 21 CFR 888.3020

Predicate Device: Synthes - LCP Wrist Fusion - K042355

Description of the Device:

The IMPLATE Wrist Arthrodesis Nail System is comprised of a titanium (Ti 6AL-4V) Distal Radius Intramedullary Nail, various lengths of titanium (Ti 6AL-4V) Metacarpal Intramedullary Nails, multiple titanium (Ti 6AL-4V) nail Connectors in various lengths and angles, and Unicortical Screws of various lengths, Pins and System specific instrumentation

Intended Use:

The Wrist Arthrodesis Nail System is intended for wrist arthrodesis. Specific indications include post-traumatic arthritis of the joints of the wrist, rheumatoid wrist deformities requiring restoration, complex carpal instability, post-septic arthritis of the wrist, severe unremitting wrist pain related to motion, brachial plexus nerve palsies, tumor resection, and spastic deformities.

Page 1 of 2

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Technological Characteristics:

The Wrist Arthrodesis Nail System has the foilowing similarities to the LCP Wrist Fusion manufactured and distributed by Synthes pursuant to K042355:

The same indications for use and intended use .
The same materials .
The same load strength .
Accommodate different size anatomies. �

Biocompatibility:

The materials selected for the Wrist Arthrodesis Nail System have a long history of safe use in the orthopedic industry. The materials are medical grade titanium alloy and cobalt chrome.

Comparison of Technological Modifications:

In contrast to the predicate device, the Wrist Arthrodesis Nail System was designed to be placed within the medullary canal. Placement within the medullary canal reduces the possibility of soft tissue irritation and subcutaneous prominence. Intramedullary placement also minimizes the size of the surgical incision.

Summary of Non-Clinical Testing:

The following tests were performed to demonstrate that the Wrist Arthrodesis Nail System is safe and effective:

Static four point bending test in accordance with ASTM F82 was performed to determine . the bending strength of the subject device and compare the yield point and bending stiffness to that of the predicate. All subject devices tested passed the acceptance criteria without failure.
A dynamic four point bending test in accordance with ASTM F1264 was performed to . determine the maximum run out value at 1,000,000 cycles. The testing confirmed the endurance value of 1,000,000 cycles without evidence of failure.
A torque test was performed to challenge the strength of the connector. All subject . devices tested passed the acceptance criteria without evidence of failure.
A pull test was performed to challenge the interconnection of the connector to the . metacarpal and radius nails. All subject devices passed the acceptance criteria without evidence of failure.
A cadaver lab was performed to confirm the repeatability of the surgical procedure. The . lab documented that the procedure is feasible and repeatable.

Conclusion:

We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

Skeletal Dynamics, LLC % Ms. Ana M. Escagedo Vice President Quality & Regulatory Affairs 8905 Southwest 87 Avenue, Suite 102 Miami, Florida 33176

JUN 2 9 2010

Re: K092720

Trade/Device Name: Wrist Arthrodesis Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 22, 2010 Received: June 23, 2010

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Ana M. Escagedo

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.htm 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.

Sincerely, yours,

Barbary Brielund

Mark N. Melke 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): Y. O9 27 ZO

Device Name: Wrist Arthrodesis Nail System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ulla Dneun

Orthopedic. ivision of Surg and Restorative Devices

510(k) Number K092730

Page li of 1

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.