The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The GEMINUS Plate System is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis and fixed anale pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics GEMINUS Plate System is comprised of:

· Titanium alloy plates, washers and screws
· Cannulated cobalt chrome polyaxial locking screws
· Stainless steel k-wires (for provisional fixation not for implantation)
· System specific instrumentation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Skeletal Dynamics GEMINUS Volar Distal Radius Plate System." This submission is for a mechanical device (bone fixation plate system), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (like AI performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.

The "study" described in this document is performance testing, specifically static and fatigue testing of the mechanical device. The acceptance criteria for such a device are typically established based on recognized industry standards for orthopedic implants and direct comparison to a predicate device.

Here's an attempt to answer the questions based on the provided document, noting where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (as described)
Mechanical Performance	Device passed static and fatigue testing.
Equivalence to Predicate	"Equivalent to the cleared Geminus Volar Distal Radius Plate System (K111620)" and "as safe and effective as the Skeletal Dynamics Volar Distal Radius Plate System (K111620) and the Synthes Titanium Alloy Volar Distal Radius Plate System (K963798)."
Material Properties	Titanium alloy plates, washers, screws. Cannulated cobalt chrome polyaxial locking screws. (Implies materials meet standards for biocompatibility and strength, though not explicitly detailed as acceptance criteria).
Intended Use	"Intended for fixation of fractures and osteotomies of the distal radius." (Matches predicate and intended use).
Design	"Similarities in design (fundamental scientific technology)" to predicate. Minor differences (cobalt chrome polyaxial locking screw) do not raise new safety/effectiveness concerns.
Sterility	"Similarities in sterility" to predicate (provided non-sterile, sterilized in user facility).
Packaging	"Similarities in packaging" to predicate.

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

Sample Size: Not specified in terms of number of physical test units. Mechanical testing typically involves a specific number of samples to achieve statistical significance, but the exact count isn't in this summary.
Data Provenance: Not applicable in the context of patient data. The "data" here comes from mechanical laboratory testing of the device components/system.

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

Not applicable as this is a mechanical device. "Ground truth" in this context would be engineering specifications and standards for mechanical performance, not expert medical opinion on clinical cases. The testing would be performed by qualified engineers or technicians in a laboratory setting.

4. Adjudication Method for the Test Set

Not applicable for mechanical device testing. The results of static and fatigue tests are quantitative measurements assessed against pre-defined engineering standards or comparative data from predicate devices.

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 mechanical orthopedic implant, not an AI or SaMD.

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

Not applicable. This is a mechanical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for evaluating this device's performance would be recognized engineering standards for orthopedic implants (e.g., ASTM standards for static and fatigue testing of bone plates) and comparative data from the legally marketed predicate devices. The goal is to demonstrate that the new device performs at least as well as, or equivalently to, the predicate devices under these standard mechanical tests.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI or SaMD requiring a training set.

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

Not applicable. This is a mechanical device, not an AI or SaMD.

Summary

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

122737
510(k) SUMMARY

Page 1/2

OCT

3 2012

SKELETAL DYNAMICS, LLC's GEMINUS VOLAR DISTAL PLATE SYSTEM

October 2, 2012

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, President Email: aescagedo@skeletaldynamics.com Establishment registration number: 3006742481

Trade name, common name, classification:

Trade names	Skeletal Dynamics Geminus Volar Distal Radius Plate System
Common name:	plate, fixation, bone
Classification:	21 CFR §888.3030, Single/multiple component metallic bone fixationappliances and accessories
Product code:	HRS
Class:	Class II

Predicate devices:

Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K111620) Synthes Titanium Alloy Volar Distal Radius Plate System (K963798) Hand Innovations Multidirectional Threaded Peg (K060864)

Description of the device:

The Skeletal Dynamics GEMINUS Plate System is comprised of:

· Titanium alloy plates, washers and screws
· Cannulated cobalt chrome polyaxial locking screws
· Stainless steel k-wires (for provisional fixation not for implantation)
· System specific instrumentation.

Intended use:

The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.

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

K.122737

Summary of technological characteristics / substantial equivalence:

The substantial equivalence of the Skeletal Dynamics GEMNUS Volar Distal Radius Plate system to the predicate device are 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:

Static and fatigue testing was performed which shows that the Geminus Volar Distal Radius Plate System is equivalent to the cleared Geminus Volar Distal Radius Plate System (K111620),

Conclusion

The Skeletal Dynamics Geminus Volar Distal Radius Plate System has the same intended use and indications, principles of operation and technological characteristics as the predicate. The minor differences in the addition of a cobalt chrome polyaxial locking screw (the same material as the Hand Innovations Multidirectional Threaded Peg (K060864)) do not raise any new questions of safety or effectiveness. Performance data demonstrates that the Geminus Volar Distal Radius Plate System is as safe and effective as the Skeletal Dynamics Volar Distal Radius Plate System (K111620) and the Synthes Titanium Alloy Volar Distal Radius Plate System (K963798). Thus, the Geminus Volar Distal Radius Plate System is substantially equivalent to its predicate device.

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

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

OCT
3 2012

Skeletal Dynamics, LLC % Ms. Ana Escagedo President 8905 Southwest 87th Avenue, Suite 201 Miami, Florida 33176

Re: K122737

Trade/Device Name: Skeletal Dynamics Geminus Volar Distal Radius Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: September 5, 2012 Received: September 6, 2012

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 hiability 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

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

Page 2 - Ms. Ana Escagedo

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 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 yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ·

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

Indications for Use Statement

K122737 510(k) Number (if known):

Device Name: Skeletal Dynamics Fossa Specific Plate System

Indications for Use:

The Skeletal Dynamics GEMINUS Fossa Specific Plate System is intended for fixation of fractures and osteotomies of the distal radius.

Prescription Use x (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashf

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

K122737 510(k) Number J

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.