SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS

K111620 · Skeletal Dynamics, LLC · HRS · Aug 23, 2011 · Orthopedic

Device Facts

• Record ID: K111620
• Device Name: SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS
• Applicant: Skeletal Dynamics, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Aug 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Geminus Volar Distal Radius Plate System is a bone fixation device used for the repair of distal radius fractures and osteotomies. The system consists of medical-grade titanium alloy plates, cortical locking screws, and fixed-angle pegs, along with stainless steel K-wires for provisional fixation and specialized instrumentation. The device is provided non-sterile and requires sterilization at the user facility. It is intended for use by surgeons in a clinical or hospital setting to stabilize bone fragments. The plates are affixed to the diaphysis using cortical locking screws, while fixed-angle pegs secure distal bone fragments. By providing rigid internal fixation, the system supports bone healing and restores structural integrity to the distal radius.

Clinical Evidence

No clinical data. Substantial equivalence is supported by preclinical mechanical testing, including static, fatigue, and dynamic testing, and cadaveric testing.

Technological Characteristics

Materials: Medical grade titanium alloy (plates, screws, washers), stainless steel (K-wires). Design: Bone plate system with cortical locking screws and fixed-angle pegs. Connectivity: None. Sterilization: Non-sterile, user-facility sterilized.

Indications for Use

Indicated for fixation of fractures and osteotomies of the distal radius in patients requiring surgical stabilization.

Regulatory Classification

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.

Predicate Devices

• Synthes Titanium Alloy Volar Distal Radius Plate System (K963798)

Submission Summary (Full Text)

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K111620

12

AUG 2 3 2011

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## 510(k) Summary of Safety and Effectiveness Skeletal Dynamics Geminus Volar Distal Radius Plate System

August 3, 2011

## Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 201 Miami, FL 33176 Tel: [phone] Fax: [phone] Contact: Ana M. Escagedo, Vice President Email: [e-mail]

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 Product Code HRS Class Class II

#### Predicate Devices:

Synthes Titanium Alloy Volar Distal Radius Plate System (K963798)

#### Description of the Device:

The Skeletal Dynamics Geminus Volar Distal Radius Plate System contains bone plates for the repair of either distal or volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation.

The Skeletal Dynamics 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 and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics Geminus Volar Distal Radius Plate System is comprised of:

- · titanium alloy plates, washers and screws
- · stainless steel K-wires (for provisional fixation not for implantation)
- · system specific instrumentation.

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### Intended Use:

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

### Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Geminus Volar Distal Radius Plate 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 analysis and cadaveric testing demonstrated that the Skeletal Dynamics Geminus Volar Distal Radius Plate System is substantially equivalent to the predicate device which is currently marketed. Mechanical testing which established equivalency included static, fatigue and dynamic testing. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

#### Conclusion:

The Skeletal Dynamics Geminus Volar Distal Radius Plate System is substantially equivalent to the predicate device identified in this premarket notification.

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KIII620

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

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

AUG 23 2011

Re: K111620

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: II Product Code: HRS, HWC Dated: August 2, 2011 Received: August 4, 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.

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

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Page 2 - Ms. Ana Escagedo

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 forth in the quality systems (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin I. Keith

-S- 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): KHI620

Device Name: Skeletal Dynamics 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 X (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 Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111620