K Number
K122310
Device Name
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
Date Cleared
2013-01-18

(170 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.
Device Description
The 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 a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates. The Geminus Volar Distal Radius Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis, fixed angle pegs are used for distal bone fragments. The titanium Hook Plate Extension locks to the plate by a means of titanium screw. The system is provided non-sterile and is sterilized in the user facility. The Geminus Volar Distal Radius Plate System is comprised of: - · Titanium alloy plates, washers and screws - · Cannulated cobalt chrome polyaxial locking screws - · Titanium alloy hook plate extension - · Stainless steel k-wires (for provisional fixation not for implantation) - · System specific instrumentation.
More Information

Not Found

No
The description focuses solely on the mechanical components and materials of a surgical plate system for bone fixation. There is no mention of software, algorithms, or data processing that would indicate AI/ML.

No
The device is intended for fixation of fractures and osteotomies, which is a supportive and structural role, not a therapeutic one that actively treats a disease.

No

The device is a system of plates, screws, and instruments used for surgical fixation of fractures and osteotomies of the distal radius, which is a therapeutic function, not diagnostic.

No

The device description explicitly lists multiple hardware components including bone plates, screws, pegs, and instrumentation, indicating it is a physical medical device system, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the "fixation of fractures and osteotomies of the distal radius." This describes a surgical procedure to repair bone, not a test performed on samples taken from the body to diagnose a condition.
  • Device Description: The description details bone plates, screws, pegs, and instrumentation used for surgical implantation. This is consistent with a surgical implant and its associated tools, not an in vitro diagnostic device.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.

IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is used in vivo (inside the body) as a surgical implant.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

HRS

Device Description

The 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 a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The Geminus Volar Distal Radius Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis, fixed angle pegs are used for distal bone fragments. The titanium Hook Plate Extension locks to the plate by a means of titanium screw. The system is provided non-sterile and is sterilized in the user facility.

The Geminus Volar Distal Radius Plate System is comprised of:

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

distal radius

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Preclinical analysis and testing demonstrated that the Skeletal Dynamics Geminus Volar Distal Radius Plate System is substantially equivalent to the predicate devices which are currently marketed. Mechanical testing which established equivalency included static and dynamic testing. Therefore, the subject device is equivalent to the legally marketed predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111620, K122737, K963798, K951303

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

0

510(k) SUMMARY

SKELETAL DYNAMICS, LLC's GEMINUS VOLAR DISTAL RADIUS PLATE SYSTEM

JAN 1 8 2013

January 11, 2013

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 namesGeminus Volar Distal Radius Plate System
Common name:Plate, fixation, bone
Classification:21 CFR §888.3030, Single/Multiple Component Metallic Bone Fixation
Appliances and Accessories
Product code:HRS
Class:Class II

Predicate devices:

Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K111620, K122737), Synthes Distal Radius Plate (K963798), and Medpac SFC (K951303)

Description of the device:

The 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 a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The Geminus Volar Distal Radius Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis, fixed angle pegs are used for distal bone fragments. The titanium Hook Plate Extension locks to the plate by a means of titanium screw. The system is provided non-sterile and is sterilized in the user facility.

The Geminus Volar Distal Radius Plate System is comprised of:

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

Intended use:

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

1

Summary of technological characteristics / substantial equivale nce:

The substantial equivalence of the Skeletal Dynamics Geminus Volar Distal Radius Plate System to the predicate devices 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:

Preclinical analysis and testing demonstrated that the Skeletal Dynamics Geminus Volar Distal Radius Plate System is substantially equivalent to the predicate devices which are currently marketed. Mechanical testing which established equivalency included static and dynamic testing. Therefore, the subject device is equivalent to the legally marketed predicate devices.

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 minor difference in the hook plate extension does 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 Geminus Volar Distal Radius Plate System (K111620, K122737) and therefore is substantially equivalent to its predicate devices.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a stylized human figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: January 18, 2013

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

Re: K122310

Trade/Device Name: 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: November 30, 2012 Received: December 3, 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 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

3

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 yours,

Mark N. Melkerson

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

Enclosure

4

Indications for Use Statement

510(k) Number (if known): K122310

Device Name: GEMINUS Volar Distal Radius Plate System

Indications for Use:

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

Prescription Use × (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)

Michael C. Owens 2013.01.18 14:23:35 -05'00'

Division of Orthopedic Devices