(85 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of metal plates, screws, and sutures for fracture fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, through its plates and screws, is intended for fixation of clavicle fractures, which directly treats and rehabilitates a medical condition.
No
Explanation: The device is described as a fixation system for clavicle fractures, consisting of plates, screws, and sutures used for repair. Its intended use is to mechanically support and stabilize fractured bones, not to diagnose medical conditions.
No
The device description explicitly lists implantable hardware components (plates, screws, suture anchor, etc.) made of stainless steel and polyethylene suture.
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 clavicle fractures in adult patients. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of implantable components (plates, screws, suture anchor, etc.) made of stainless steel and polyethylene suture. These are physical implants used to stabilize bone fractures.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is used on the clavicle and shoulder, which are parts of the human body, not in vitro specimens.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological specimens for diagnostic purposes. This device is clearly an implantable surgical device used in vivo (inside the body) for structural support.
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. For lateral clavicle fractures, the Suspension™ Clavicle Fracture Fixation System may also be used with the Suspension™ Acromioclavicular (AC) Repair System.
Product codes
HRS, HWC, MBI
Device Description
The subject device consists of the following implantable components:
-
- Three sizes of clavicle fracture plate for each shoulder (i.e. small, medium, and large; each with Left & Right configurations)
-
- Eight 2.7mm lengths of non-locking & locking bone screws
-
- Eight 3.5mm lengths of non-locking & locking bone screws
Implantable components are included in a carrier case and must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but are for single-use only. All implantable components are composed of stainless steel.
The optionally accompanying Suspension™ Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor with pre-threaded suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. Implantable portions of the device are: USP size 5 braided polyethylene suture, coracoid anchor, clavicle set screw, clavicle sleeve extension washer, clavicle sleeve.
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
hospital or surgical center
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
The subject device was tested in multiple cadaver shoulders using the proposed method of application. The subject device was compared to the currently marketed Smith & Nephew (K061352). Using an Instron™ device, assessments were made for yield load, stiffness, ultimate load and failure mode. Testing showed that the proposed method of application did not adversely impact the integrity of the construct and substantially equivalent results were observed compared to standard plates.
The subject device was tested in simulated bone. In all instances, the suture component of the subject Acromioclavicular System failed in pull tests before any damage was incurred by the Clavicle Plate. Testing showed that the proposed method of application did not adversely impact the integrity of the clavicle construct.
Engineering analysis has determined that the new connection between the clavicle washer sleeve in the Suspension™ Acromioclavicular Repair System and the subject clavicle plate does not represent a new worst case condition for concerns regarding fretting or corrosion.
Biocompatibility for the device was previously demonstrated in K102095. There have been no changes of any kind to the materials used in the device.
Sterility validation testing was previously presented in K102095. There have been no changes of any kind to the methods of sterilization or to the product packaging. Likewise, there have been no modifications to the design of any components of the device such that sterilization might be affected.
Additionally there have been no changes to the design, materials, packaging, sterilization or other features of the optionally accompanying Suspension™ Acromioclavicular (AC) System (K102143).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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DEC 2 7 2011
510(k) SUMMARY
December 23, 2011
Premarket Notification Number: K112923 Suspension™ Clavicle Fracture Fixation System
Device Classification: Class II (Ref. CFR 21 §888.3030) Single/multiple component metallic bone fixation appliances and accessories
Sponsor:
Suspension Orthopedic Solutions, Inc 1507 Richie Hwy. Suite 101 Arnold, MD 21012
Sponsor's Representative
Curtis Raymond Orchid Design 80 Shelton Technology Center Shelton Connecticut 06484 Telephone 203-922-0105
Device Description:
The subject device consists of the following implantable components:
-
- Three sizes of clavicle fracture plate for each shoulder (i.e. small, medium, and large; each with Left & Right configurations)
-
- Eight 2.7mm lengths of non-locking & locking bone screws
-
- Eight 3.5mm lengths of non-locking & locking bone screws
Implantable components are included in a carrier case and must be steam sterilized by the hospital or surgical center. These components are intended for re-sterilization, but are for singleuse only. All implantable components are composed of stainless steel.
The optionally accompanying Suspension™ Acromioclavicular (AC) Repair System is an internal fixation system consisting of a non-absorbable suture anchor with pre-threaded suture. The metallic suture anchor and metallic accessories are fabricated from 316L stainless steel. Implantable portions of the device are: USP size 5 braided polyethylene suture, coracoid anchor, clavicle set screw, clavicle sleeve extension washer, clavicle sleeve.
Intended 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. For lateral clavicle fractures, the Suspension™ Clavicle Fracture Fixation System may also be used with the Suspension™ Acromioclavicular (AC) Repair System.
Predicate Device(s):
No component of the subject device has been changed in its design, component material, sterilization method, or in any other way from that described in K102095. The sole change to
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KII2923
the device is to allow optional, concurrent use of the Suspension™ Acromioclavicular (AC) System in those instances where lateral clavicle fractures are encountered. Likewise, there have been no changes of any kind made to the Suspension™ Acromioclavicular (AC) System other than allowing its use in conjunction with the subject Clavicle Fixation Plate.
Performance Testing:
The subject device was tested in multiple cadaver shoulders using the proposed method of application. The subject device was compared to the currently marketed Smith & Nephew (K061352). Using an Instron™ device, assessments were made for yield load, stiffness, ultimate load and failure mode. Testing showed that the proposed method of application did not adversely impact the integrity of the construct and substantially equivalent results were observed compared to standard plates.
The subject device was tested in simulated bone. In all instances, the suture component of the subject Acromioclavicular System failed in pull tests before any damage was incurred by the Clavicle Plate. Testing showed that the proposed method of application did not adversely impact the integrity of the clavicle construct.
Engineering analysis has determined that the new connection between the clavicle washer sleeve in the Suspension™ Acromioclavicular Repair System and the subject clavicle plate does not represent a new worst case condition for concerns regarding fretting or corrosion.
Safety Testing:
Biocompatibility for the device was previously demonstrated in K102095. There have been no changes of any kind to the materials used in the device.
Sterility validation testing was previously presented in K102095. There have been no changes of any kind to the methods of sterilization or to the product packaging. Likewise, there have been no modifications to the design of any components of the device such that sterilization might be affected.
Additionally there have been no changes to the design, materials, packaging, sterilization or other features of the optionally accompanying Suspension™ Acromioclavicular (AC) System (K102143).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" and is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Suspension Orthopaedic Solutions, LLC % Orchid Design Mr. Curtis Raymond Senior Regulatory and Quality Consultant 80 Shelton Technology Center Shelton, Connecticut 06484
DEC 2 7 2011
Re: K112923
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, MBI Dated: September 30, 2011 Received: October 3, 2011
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.
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
3
Page 2 - Mr. Curtis Raymond
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 A. Milliken
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
K112923 510(k) Number (if known):_
Device Name: Suspension™ Clavicle Fracture Fixation System
Intended 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. For lateral clavicle fractures, the Suspension™ Clavicle Fracture
Fixation System may also be used with the Suspension™ Acromioclavicular (AC)
Repair System.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
ichel Nune
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number .
K12923
AS-