(134 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is used for the "fixation of clavicle fractures," which is a medical intervention to treat an injury, thereby making it a therapeutic device.
No
The device is an internal fixation system (plates and screws) used for treating clavicle fractures, not for diagnosis.
No
The device description explicitly details physical implantable components (plates and screws made of 316L Stainless Steel) and associated surgical instrumentation. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of clavicle fractures" in adult patients. This is a surgical procedure performed directly on the patient's body to stabilize a broken bone.
- Device Description: The device consists of implantable plates and screws made of stainless steel, along with surgical instruments. These are physical components used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
This device is clearly an implantable surgical device used for orthopedic fixation, not for testing biological samples.
N/A
Intended Use / Indications for Use
The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.
Product codes
HRS, HWC
Device Description
The Suspension™ Clavicle Fracture Fixation System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from 316L Stainless Steel.
The device consists of the following implantable components (some or all of which may be used based on the nature of the injury):
-
- Three (3) Sizes of Clavicle Fracture Plate for Each Shoulder (i.e. small, medium, and large; each with Left & Right).
-
- Eight (8) Lengths each of 2.7mm Non-Locking & Locking Bone Screws.
-
- Eight (8) Lengths each of 3.5mm Non-Locking & Locking Bone Screws.
Implantable components are included in a surgical tray that must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but these components are for single use only.
The implants are used with instrumentation including:
- Hex Driver .
- o Handle and a 2.5mm hex driver for hand tightening bone screws
- Assorted Drill bits .
- o To create pilot holes for bone screws. The drill bits are compatible with most AO connections.
- Drill Guide Assemblies .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle / Shoulder
Indicated Patient Age Range
adult patients
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)
The material (316L Stainless Steel) selected is commonly used for orthopedic implants with a long history of biocompatibility.
The devices have been subjected to recognized consensus standards for these types of devices and perform in a manner equivalent to the predicate devices. The device has been subjected to non-clinical testing including Torsional Strength and Break, Four Point Bending, Screw Driving Torque, and Predicate Device Comparison Analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K102095 510(k) Summary
DEC - 7 2010
Suspension™ Clavicle Fracture Fixation System
July 23, 2010
Submitter/Regulatory Contact:
Joseph Azarv Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Email: joseph.azary@orchid-orthopedics.com
Sponsor/Manufacturer:
Suspension Orthopaedic Solutions, LLC 2635 Riva Road, Suite 100 Annapolis, MD 21401
FDA Establishment Registration Number: Pending
Trade Name, Common Name, Classification:
Device Trade Name: Suspension™ Clavicle Fracture Fixation System
Device Common or Usual Names: Bone Plates, Bone Screws
Classification: Class II
Classification Name: Single/Multiple component metallic bone fixation appliances and accessories
Regulation: 21 CFR 888.3030
Product Codes: HRS and HWC
1
Predicate Device:
Smith & Nephew Peri-Loc locking bone plates, locking and non-locking bone screws for the upper extremity - K061352
Description of the Device:
The Suspension™ Clavicle Fracture Fixation System is an internal fixation system consisting of various sized plates and screws. The plates and screws are fabricated from 316L Stainless Steel.
The device consists of the following implantable components (some or all of which may be used based on the nature of the injury):
-
- Three (3) Sizes of Clavicle Fracture Plate for Each Shoulder (i.e. small, medium, and large; each with Left & Right).
-
- Eight (8) Lengths each of 2.7mm Non-Locking & Locking Bone Screws.
-
- Eight (8) Lengths each of 3.5mm Non-Locking & Locking Bone Screws.
Implantable components are included in a surgical tray that must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but these components are for single use only.
The implants are used with instrumentation including:
- Hex Driver .
- o Handle and a 2.5mm hex driver for hand tightening bone screws
- Assorted Drill bits .
- o To create pilot holes for bone screws. The drill bits are compatible with most AO connections.
- Drill Guide Assemblies .
Intended Use:
The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. Suspension " Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.
2
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Technological Characteristics:
The subject devices are substantially equivalent to the predicate devices. Both the subject device and predicate device have indications for clavicle. However, the predicate device also has indications for many other bones (including tibia, femur, pelvis, humerus, metacarpals, etc). The devices are composed of the same materials, and have the same sterility. The devices are used with 3.5mm and 2.7mm locking or non-locking screws.
Performance:
The material (316L Stainless Steel) selected is commonly used for orthopedic implants with a long history of biocompatibility.
The devices have been subjected to recognized consensus standards for these types of devices and perform in a manner equivalent to the predicate devices. The device has been subjected to non-clinical testing including Torsional Strength and Break, Four Point Bending, Screw Driving Torque, and Predicate Device Comparison Analysis.
Conclusion:
We believe that based on the predicate device comparison and the non-clinical testing performed the subject devices are substantially equivalent to the predicate devices and conclude that the subject devices are as safe and effective as the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Suspension Orthopaedic Solutions, LLC % Mr. Curtis Raymond Senior Regulatory & Quality Consultant Orchid Design, A Division of Orchid Orthopedic Solutions 80 Shelton Technology Center Shelton, Connecticut 06484
DEC - 7 2010
Re: K102095
Trade/Device Name: Suspension™ Clavicle Fracture Fixation 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, HWC Dated: November 24, 2010 Received: November 29, 2010
Dear Mr. Raymond:
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
4
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 (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. 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):
DEC - 7 2010
Device Name: Suspension™ Clavicle Fracture Fixation System
Indications For Use:
់
The Suspension™ Clavicle Fracture Fixation System can be used for adult patients. The Suspension™ Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.
Prescription Use × (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)
Page 1 of 1
for M. Mulkerson
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102095
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