(27 days)
Not Found
No
The summary describes a mechanical implant system for bone fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended for the "fixation of fractures and osteotomies of the distal radius," which is a therapeutic intervention aimed at restoring function and promoting healing of an injured anatomical site.
No
The device is a system of plates, screws, and instrumentation intended for fixation of fractures and osteotomies, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly lists hardware components such as bone plates, screws, pegs, and instrumentation, indicating it is a physical implant system, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of fractures and osteotomies of the distal radius." This describes a surgical implant used to stabilize bone, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details bone plates, screws, pegs, and instrumentation used in surgery. It does not mention any components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
This device is clearly a surgical implant for orthopedic use.
N/A
Intended Use / Indications for Use
The Skeletal Dynamics GEMINUS Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.
The Skeletal Dynamics GEMINUS Fossa Specific Plate System is intended for fixation of fractures and osteotomies of the distal radius.
Product codes
HRS
Device Description
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.
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)
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K111620), Synthes Titanium Alloy Volar Distal Radius Plate System (K963798), Hand Innovations Multidirectional Threaded Peg (K060864)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 fixation |
| appliances 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 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.
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