(29 days)
No
The device description and performance studies focus on the mechanical properties and design of bone plates and screws, with no mention of AI or ML.
Yes
The device is described as "Plating System" that consists of "washers, screws, and plates" intended for "fracture fixation of long bones," which directly treats a medical condition.
No
The document describes the VariAx Elbow Plating System, which is a device intended for the fixation and repair of fractures in long bones. It does not perform any diagnostic functions or provide information on the state of a patient's health for diagnosis.
No
The device description explicitly states that the VariAx Elbow Plating System consists of washers, screws, and plates, which are physical hardware components made of Titanium Alloy. The submission is for a line extension of these physical plates.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fracture fixation of long bones," specifically the distal humerus and proximal ulna. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device consists of "washers, screws, and plates," which are implants used to stabilize bone fractures. This is consistent with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used to treat a physical condition (fractures).
N/A
Intended Use / Indications for Use
The VariAx Elbow Plating System is intended for fracture fixation of long bones.
The distal humerus plates are indicated for:
- intra-articular or extraarticular fractures of the distal humerus
- osteotomies
- nonunions
The olecranon plates are indicated for:
- intra-articular or extraarticular fractures of the proximal ulna
- osteotomies ●
- . nonunions
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Elbow Plating System, which was previously cleared in the VariAx Elbow Plating System (K073527 & K101056). The VariAx Elbow Plating System consists of washers, screws, and plates. This submission is intended to introduce 2 & 3-hole plates to the Lateral and Posterior Lateral plate range as well as 3-hole plates to the Posterior Medial, Medial Extended and the Olecranon plate ranges. All of the plates except for the Olecranon plates are Distal Humerus plates. The subject plates are fixed to the distal humerus and Olecranon using 2.7mm or 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056, K132502 and K140769. The subject plates are available sterile and non-sterile. The subject and predicate plates are manufactured from Titanium Alloy per ASTM F136 and Commercial Pure Titanium per ASTM F67.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal humerus, proximal ulna (Olecranon)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. The following testing was performed: "Standard Specification and Test Method for Metallic Bone Plates" as per ASTM F382-. 99 (reapproved 2008). Testing demonstrated that the subject plates are substantially equivalent to the currently marketed predicate devices. Clinical testing was not required for this submission.
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.
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.
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
JUL 2 2 2014
| Proprietary Name: | VariAx Elbow Plating System |
|---|---|
| Common Name: | Plate, Fixation, Bone |
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliance |
| and accessories 21 CFR §888.3030 | |
| Regulatory Class: | Class II |
| Product Codes: | HRS: Plate, Fixation, Bone |
| Sponsor: | Stryker Trauma AG |
| Contact Person: | Elijah N. Wreh |
| Regulatory Affairs Specialist | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| elijah.wreh@stryker.com | |
| Phone: 201-831-5691 | |
| Fax: 201-831-4691 | |
| Date Prepared: | June 20, 2014 |
Description
This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Elbow Plating System, which was previously cleared in the VariAx Elbow Plating System (K073527 & K101056). The VariAx Elbow Plating System consists of washers, screws, and plates. This submission is intended to introduce 2 & 3-hole plates to the Lateral and Posterior Lateral plate range as well as 3-hole plates to the Posterior Medial, Medial Extended and the Olecranon plate ranges. All of the plates except for the Olecranon plates are Distal Humerus plates. The subject plates are fixed to the distal humerus and Olecranon using 2.7mm or 3.5mm locking or non-locking screws. These screws were cleared in K073527, K101056, K132502 and K140769. The subject plates are available sterile and non-sterile. The subject and predicate plates are manufactured from Titanium Alloy per ASTM F136 and Commercial Pure Titanium per ASTM F67.
1
Intended Use
The VariAx Elbow Plating System is intended for fracture fixation of long bones.
Indications for Use
The VariAx Elbow Plating System is intended for fracture fixation of long bones. The distal humerus plates are indicated for:
- intra-articular or extraarticular fractures of the distal humerus .
- osteotomies .
- nonunions .
The olecranon plates are indicated for:
- intra-articular or extraarticular fractures of the proximal ulna .
- osteotomies ●
- . nonunions
Summary of Technology
The device comparison showed that the subject device is substantially equivalent in intended use, design, materials and operational principles to the VariAx Elbow Plating System (K101056) and the Synthes 3.5mm LCP Distal Humerus System (K033995) for fracture fixation of long bones.
Non-Clinical Testing
Non-clinical laboratory testing was performed on the worst case subject plates to determine substantial equivalence. The following testing was performed:
- "Standard Specification and Test Method for Metallic Bone Plates" as per ASTM F382-. 99 (reapproved 2008)
Testing demonstrated that the subject plates are substantially equivalent to the currently marketed predicate devices.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject VariAx Elbow Plating System is substantially equivalent to the predicate devices identified throughout this submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2014
Stryker Trauma AG Mr. Elijah N. Wreh Regulatory Affairs Specialist 325 Cornorate Drive Mahwah, New Jersey 07430
Rc: K141677
Trade/Device Name: VariAx Elbow Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS Dated: June 20, 2014 Received: June 23, 2014
Dear Mr. Wrch:
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
3
Page 2 - Mr. Elijah N. Wreh
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| 510(k) Number (if known) | K141677 | |
| Device Name | VariAx Elbow Plating System | |
| Indications for Use (Describe) | The VariAx Elbow Plating System is intended for fracture fixation of long bones.
The distal humerus plates are indicated for:
• intra-articular or extraarticular fractures of the distal humerus
• osteotomies
• nonunions
The olecranon plates are indicated for:
• intra-articular or extraarticular fractures of the proximal ulna
• osteotomies
• nonunions | |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Elizabeth Frank -S |
|---|---|
| Division of Orthopedic Devices |
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