(185 days)
No
The document describes a system of plates and screws for bone fracture fixation, which are purely mechanical devices. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
The device is a plating system intended for long bone fracture fixation, non-unions, malunions, osteotomies, and periprosthetic fractures. It provides mechanical support rather than therapeutic action.
No
The device, AxSOS 3 Ti Plating System, is described as a system of plates and screws intended for long bone fracture fixation, non-unions, malunions, and osteotomies. Its function is to fix bones, not to diagnose conditions.
No
The device description clearly states it consists of various monoaxial plates and screws made from Ti-6AI-4V, which are physical hardware components used for fracture fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "long bone fracture fixation." This is a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is described as a "Plating System" consisting of plates and screws made from titanium. These are implants used to stabilize bones.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) to provide information about a physiological state, health, or disease.
IVD devices are used in vitro (outside the body) to diagnose or monitor conditions. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
AxSOS 3 Ti is intended for long bone fracture fixation.
Indications include:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions and malunions
- · Normal and osteopenic bone
- · Osteotomies
- · Periprosthetic fractures of the femur and proximal tibia
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- · Periprosthetic fractures
- · Diaphyseal and metaphyseal areas of long bones in pediatric patients.
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The AxSOS 3 Ti Plating System consists of various monoaxial plates and screws made from Ti-6AI-4V (ASTM F-136 ELI). The system contains previously cleared distal lateral femur plates, proximal lateral tibial plates, distal anterolateral tibia plates, distal medial plates, proximal medial tibia plates and proximal humerus plates provided in various lengths (K123964, K133440, K141121, and K143138). This premarket notification introduces 4.0 mm waisted compression plates and 5.0 mm broad and narrow waisted compression plates in various lengths and number of holes. The system contains previously cleared screws with various lengths and diameters and provided in various configurations (fully or partially threaded) identified in previously cleared premarket notifications (K123964, K133440, K141121, and K143138). This premarket notification introduces blind screws used with the 4.0 mm and 5.0 mm waisted compression plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone, femur, proximal tibia, scapula, pelvis
Indicated Patient Age Range
Pediatric 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)
Bench Testing: An engineering analysis was performed comparing the specific predicate devices.
Animal Testing: Animal testing was not required for this submission.
Clinical Testing: 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.
K141121, K143138, K113048, K122005, K132591
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
Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
Stryker GmbH Saad Attiyah Senior Regulatory Affairs Manager Bohnackerweg 1 2545 Selzach, CH 2545 SWITZERLAND
Re: K153379 Trade/Device Name: AxSOS 3 Ti 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: April 25, 2016 Received: April 26, 2016
Dear Saad Attiyah:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name AxSOS 3 Ti
Indications for Use (Describe)
AxSOS 3 Ti is intended for long bone fracture fixation.
Indications include:
- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions and malunions
- · Normal and osteopenic bone
- · Osteotomies
- · Periprosthetic fractures of the femur and proximal tibia
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- · Periprosthetic fractures
- · Diaphyseal and metaphyseal areas of long bones in pediatric patients.
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Pg.1/3
Section 7. 510(k) Summary
| Submitter: | Stryker GmbH
Bohnackerweg 1
2545 Selzach
Switzerland |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Saad Attiyah
Senior Regulatory Affairs Manager
Phone: 201-831-5655
Fax: 201-831-4691 |
| Establishment Number
Date Prepared: | 8031020
May 24, 2016 |
| Name of Device: | AxSOS 3 Ti |
| Common or Usual Name | Bone Plates
Bone Screws |
| Classification Name: | Single/multiple component metallic
bone fixation
Appliance and accessories |
| | 21 CFR §888.3030 |
| | Smooth or threaded metallic bone
fixation fastener |
| Regulatory Class: | 21 CFR §888.3040
II |
| Product Codes: | HRS: Plate, Fixation, Bone
HWC: Screw, Fixation, Bone |
| Predicate Device: | AxSOS 3 Ti Locking Plate System
(K141121)
AxSOS 3 Ti Locking Plate System
(K143138)
OrthoHelix Surgical Design (K113048,
K122005, K132591) |
| Reference Device: | Zimmer NCB Blind Screw Insert
(K113718) |
4
The AxSOS 3 Ti Locking Plate System is
intended for long bone fracture fixation Indications for Use: AxSOS 3 Ti is intended for long bone fracture fixation. Indications include: · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions and malunions · Normal and osteopenic bone · Osteotomies · Periprosthetic fractures of the femur and proximal tibia The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: · Periprosthetic fractures • Diaphyseal and metaphyseal areas of long bones in pediatric patients. The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis. Description: The AxSOS 3 Ti Plating System consists of various monoaxial plates and screws made from Ti-6AI-4V (ASTM F-136 ELI). The system contains previously cleared distal lateral femur plates, proximal lateral tibial plates, distal anterolateral tibia plates, distal medial plates, proximal medial tibia plates and proximal humerus plates provided in various lengths (K123964, K133440, K141121, and K143138). This premarket notification introduces 4.0 mm waisted compression plates and 5.0 mm broad
Intended Use:
5
| K153379 | Pg.3/3 | |
|---|---|---|
| and narrow waisted compression | ||
| plates in various lengths and number of | ||
| holes. | ||
| The system contains previously cleared | ||
| screws with various lengths and | ||
| diameters and provided in various | ||
| configurations (fully or partially | ||
| threaded) identified in previously | ||
| cleared premarket notifications | ||
| (K123964, K133440, K141121, and | ||
| K143138). This premarket notification | ||
| introduces blind screws used with the | ||
| 4.0 mm and 5.0 mm waisted | ||
| compression plates. | ||
| Bench Testing: | An engineering analysis was performed | |
| comparing the specific predicate | ||
| devices. | ||
| Animal Testing: | Animal testing was not required for this | |
| submission. | ||
| Clinical Testing: | Clinical testing was not required for this | |
| submission. | ||
| Substantial Equivalence Statement: | Documentation is provided which | |
| demonstrates that the AxSOS 3 Ti is | ||
| substantially equivalent to its predicate | ||
| and reference devices in terms of its | ||
| material, design, and indications for | ||
| use, and performance characteristics. |